Archive for July, 2014

Malnutrition in India, High Newborn Death Rate and Stunting of Children Age Under Five Years

Posted in Biomarkers & Medical Diagnostics, Biomedical Measurement Science, Bone Disease and Musculoskeletal Disease, Cerebrovascular and Neurodegenerative Diseases, Chemical Biology and its relations to Metabolic Disease, Curation, Discovery process, Experimental validation, Explanatory, Frontiers in Cardiology and Cardiovascular Disorders, Liver & Digestive Diseases Research, Metabolomics, Nutrigenomics, Nutrition, Origins of Cardiovascular Disease, Population Health Management, Nutrition and Phytochemistry, Proteomics, tagged Childhood malnutrition, Ganges River, Himalayan Plateau, hyperhomocysteinemia, Population sanitation, Protein-energy malnutrition, S deficiency, stunting of growth, Transthyretin on July 15, 2014| Leave a Comment »

Malnutrition in India, High Newborn Death Rate and Stunting of Children Age Under Five Years

Curator: Larry H Bernstein, MD, FCAP

 

A lead report in the New York Times focuses on a major public health problem in India today, with the irony of high growth rate and malnutrition and stunting of children under age 5 years that occurs in the majority and wealthy Hindu population, but not to any comparable degree in the Muslim population or in Bangladesh.  This is prevalent along the Ganges River, which crosses India below the Himalaya Mountains.  The inference is that the problem is perhaps solely related to poor sanitation, which is to a large degree indisputable, and the disease is related to the gut microbiome (not so stated), that leaves an intestinal mucosa with flattened epithelia, and no observation is made of the submucosal thymic-derived T-cell lymphocyte population, the largest in the human body.

Moreover, I might point out that the turnover of the intestinal epithelium with its large surface area is very high under normal metabolic circumstances.  The result is that the children are malnourished, and they have visceral protein losses as well as somatic protein loss (stunted growth, probably affecting both skeletal muscle and the metaphyseal growth plates of long bones).  This is not quite stated this way.

The irony is that they have sufficient food supply, except that if there is a diarrhea or intestinal malabsorption at an early age, the children just might not eat, except for perhaps soft foods.  So it is not explicitly cleat that their is sufficient animal protein in the diet, which has a S:N ratio that is roughly twice that of an exclusively plant diet.  The distinction is made between marasmus and kwashiorkor in that in kwashiorkor the protein deficiency is in the visceral compartment.  Consequently, there is a reprioriotization of the liver to synthesize acute phase proteins with a decline in albumin, transthyretin, and retinol-binding protein.  This is not insignificant, even though there may also be an inflammatory state, as from repeated infections.

I certainly would be interested in seeing data from the ongoing study that measures the serum protein analytes, and also a measurement of serum red cell Hb, serum cysteine, homocysteine, and glutathione, and perhaps a muscle biopsy.

I go directly to the article at this point.

Poor Sanitation in India May Afflict Well-Fed Children With Malnutrition

By GARDINER HARRIS      JULY 13, 2014
http://www.nytimes.com/2014/07/15/world/asia/poor-sanitation-in-india-may-afflict-well-fed-children-with-malnutrition.html

SHEOHAR DISTRICT, India — He wore thick black eyeliner to ward off the evil eye, but Vivek, a tiny 1-year-old living in a village of mud huts and diminutive people, had nonetheless fallen victim to India’s great scourge of malnutrition.

His parents seemed to be doing all the right things. His mother still breast-fed him. His family had six goats, access to fresh buffalo milk and a hut filled with hundreds of pounds of wheat and potatoes. The economy of the state where he lives has for years grown faster than almost any other. His mother said she fed him as much as he would eat and took him four times to doctors, who diagnosed malnutrition. Just before Vivek was born in this green landscape of small plots and grazing water buffalo near the Nepali border, the family even got electricity.

So why was Vivek malnourished?

‘Bihar grew at 12% last 7 years’

Abhay Singh, TNN | Feb 15, 2014, 02.15AM IST

 

Bihar’s average annual growth rate has been 12% in the last seven fiscal years

 

 

The report has taken 1999-2006 as the cut-off period to highlight spectacular Bihar turnaround story achieved under CM Nitish Kumar.

PATNA: Bihar’s average annual growth rate has been 12% in the last seven fiscal years, one of the highest among all Indian states, on the back of high growth rate achieved in the agriculture and allied sectors. Besides, advancement has also been made in healthcare and education.

The state’s Economic Survey Report for 2013-14, which was tabled in the assembly on Friday, has concluded this. The summary of the report said, “During 1990-91 to 2005-06, the state’s income at constant prices grew at an annual rate of 5.7%.” It said after that the economy witnessed a turnaround and grew at an annual rate of 12%. “The rate of growth achieved by the economy during 2006-13 is not only much higher, but also one of the highest among all Indian states.”

The report has taken 1999-2006 as the cut-off period to highlight spectacular Bihar turnaround story achieved under CM Nitish Kumar.

 

Poor Sanitation Linked to Malnutrition in India

New research on malnutrition, which leads to childhood stunting, suggests that a root cause may be an abundance of human waste polluting soil and water, rather than a scarcity of food.

SANITATION – bathing in Ganges River contaminated by human waste

 

 

Like almost everyone else in their village, Vivek and his family have no toilet, and the district where they live has the highest concentration of people who defecate outdoors. As a result, children are exposed to a bacterial brew that often sickens them, leaving them unable to attain a healthy body weight no matter how much food they eat.

“These children’s bodies divert energy and nutrients away from growth and brain development to prioritize infection-fighting survival,” said Jean Humphrey, a professor of human nutrition at Johns Hopkins Bloomberg School of Public Health. “When this happens during the first two years of life, children become stunted. What’s particularly disturbing is that the lost height and intelligence are permanent.”

Two years ago, Unicef, the World Health Organization and the World Bank released a major report on child malnutrition that focused entirely on a lack of food. Sanitation was not mentioned. Now, Unicef officials and those from other major charitable organizations said in interviews that they believe that poor sanitation may cause more than half of the world’s stunting problems.

“Our realization about the connection between stunting and sanitation is just emerging,” said Sue Coates, chief of water, sanitation and hygiene at Unicef India. “At this point, it is still just an hypothesis, but it is an incredibly exciting and important one because of its potential impact.”

This research has quietly swept through many of the world’s nutrition and donor organizations in part because it resolves a great mystery: Why are Indian children so much more malnourished than their poorer counterparts in sub-Saharan Africa?

A child raised in India is far more likely to be malnourished than one from the Democratic Republic of Congo, Zimbabwe or Somalia, the planet’s poorest countries. Stunting affects 65 million Indian children under the age of 5, including a third of children from the country’s richest families.

This disconnect between wealth and malnutrition is so striking that economists have concluded that economic growth does almost nothing to reduce malnutrition.

Half of India’s population, or at least 620 million people, defecate outdoors. And while this share has declined slightly in the past decade, an analysis of census data shows that rapid population growth has meant that most Indians are being exposed to more human waste than ever before.

In Sheohar, for instance, a toilet-building program between 2001 and 2011 decreased the share of households without toilets to 80 percent from 87 percent, but population growth meant that exposure to human waste rose by half.

“The difference in average height between Indian and African children can be explained entirely by differing concentrations of open defecation,” said Dean Spears, an economist at the Delhi School of Economics. “There are far more people defecating outside in India more closely to one another’s children and homes than there are in Africa or anywhere else in the world.”

 

SANITATION-children defecate outside – 162 million malnourished and stunted

 

Not only does stunting contribute to the deaths of a million children under the age of 5 each year, but those who survive suffer cognitive deficits and are poorer and sicker than children not affected by stunting. They also may face increased risks for adult illnesses like diabetes, heart attacks and strokes.

“India’s stunting problem represents the largest loss of human potential in any country in history, and it affects 20 times more people in India alone than H.I.V./AIDS does around the world,” said Ramanan Laxminarayan, vice president for research and policy at the Public Health Foundation of India.

India is an increasingly risky place to raise children. The country’s sanitation and air quality are among the worst in the world. Parasitic diseases and infections like tuberculosis, often linked with poor sanitation, are most common in India. More than one in four newborn deaths occur in India.

Open defecation has long been an issue in India. Some ancient Hindu texts advised people to relieve themselves far from home, a practice that Gandhi sought to curb.

“The cause of many of our diseases is the condition of our lavatories and our bad habit of disposing of excreta anywhere and everywhere,” Gandhi wrote in 1925.

SANITATION-disposing of excreta anywhere and everywhere

 

 

Other developing countries have made huge strides in improving sanitation. Just 1 percent of Chinese and 3 percent of Bangladeshis relieve themselves outside compared with half of Indians. Attitudes may be just as important as access to toilets. Constructing and maintaining tens of millions of toilets in India would cost untold billions, a price many voters see no need to pay — a recent survey found that many people prefer going to the bathroom outside.

Few rural households build the sort of inexpensive latrines that have all but eliminated outdoor waste in neighboring Bangladesh.

“We need a cultural revolution in this country to completely change people’s attitudes toward sanitation and hygiene,” said Jairam Ramesh, an economist and former sanitation minister.

India’s government has for decades tried to resolve the country’s stubborn malnutrition problems by distributing vast stores of subsidized food. But more and better food has largely failed to reverse early stunting, studies have repeatedly shown.

India now spends about $26 billion annually on food and jobs programs, and less than $400 million on improving sanitation — a ratio of more than 60 to 1.

Lack of food is still an important contributor to malnutrition for some children, and some researchers say the field’s sudden embrace of sanitation has been overdone. “In South Asia, a more important factor driving stunting is diet quality,” said Zulfiqar A. Bhutta, a director of the Center for Global Child Health at the Hospital for Sick Children in Toronto.

Studies are underway in Bangladesh, Kenya and Zimbabwe to assess the share of stunting attributable to poor sanitation. “Is it 50 percent? Ninety percent? That’s a question worth answering,” said Dr. Stephen Luby, a professor of medicine at Stanford University who is overseeing a trial in Bangladesh that is expected to report its results in 2016. “In the meantime, I think we can all agree that it’s not a good idea to raise children surrounded by poop.”

Better sanitation in the West during the 19th and early 20th centuries led to huge improvements in health long before the advent of vaccines and antibiotics, and researchers have long known that childhood environments play a crucial role in child death and adult height.

The present research on gut diseases in children has focused on a condition resulting from repeated bacterial infections that flatten intestinal linings, reducing by a third the ability to absorb nutrients. A recent study of starving children found that they lacked the crucial gut bacteria needed to digest food.

In a little-discussed but surprising finding, Muslim children in India are 17 percent more likely to survive infancy than Hindus, even though Muslims are generally poorer and less educated. This enormous difference in infant mortality is explained by the fact that Muslims are far more likely to use latrines and live next to others also using latrines, a recent analysis found.

So widespread housing discrimination that confines many Muslims to separate slums may protect their children from increased exposure to the higher levels of waste in Hindu communities and, as a result, save thousands of Indian Muslim babies from death each year.

SANITATION-one in 4 newborn deaths related to sanitation

 

 

Discussion:

The coexistence of poor sanitation, where has a very large cultural barrier, with serious protein-energy malnutrition, is a toxic mix.  There is the comparison with the Muslim population at the adjoining border of the Ganges River outflow in Bangladesh.  One might also look at the catholic Portuguese population in Goa, the Jewish population in Mumbai and Kochi, and the nearby Catholic population.  There is no malnutrition in those populations, or in the Siiks.  This is undoubtedly a cultural phenomenon of ancient origin.  (The migration of the jews and of the catholics to Kochi occurred around the Indian Ocean at the time of Christ.  The catholic population in Goa was from Portugal.

I don’t think we have enough of the story here.  The Ganges river flows centrally across India, and is not far from the Himalayas.  This has some significance in the sufficiency of animal protein availability, and most importantly, of what I might expect of the tissue S:N ratio, which is critical for availability of methionine, S-adenosyl methionine, and mitochondrial energy reactions.  These are also mediated by transsulfuration reactions and by cystathionine beta-synthase.  Detailed discussions are available elsewhere.   It has been pointed out by Vernon Young and Yve Ingenbleek that sulfur is insufficient in the soil where there is not a lava flow of volcanic ash, which could be the case here.  So it is at best not a good geographic situation, even before compounding the issue.

The relationship to heart attack and stroke is established for elevated homocysteine.

Homocysteine and Vascular Disease
STEVEN E . S. MINER , M.D. , DAVID E .C. COLE *, M.D. , PHD. AND DUNCAN J . STEWART, M.D.
Cardiology Rounds   A U G U S T 1 9 9 6 ;  I(5)

Homocysteine is a naturally occurring, sulfur-containing amino acid. Continuously formed and catabolized in vivo, its metabolism is dependent on a complex interaction of genetics and physiology (Fig. 1). Its relevance is based on the increasing recognition of the correlation between elevated levels of homocysteine and human disease.

Table 1
Selected Determinants of Plasma Homocysteine*
1. Genetic
• Cystathionine-beta-synthase:
heterozygote mutations 0.5-1.5% {451}
• Methionine synthase: rare
• MTHFR: heterozygote mutations
approximately 50% {403}
2. Physiologic
• age: Hcy increases with increasing age {336}
• sex: pre-and post-menopausal women
have lower levels than men {247}
• diet: related to methionine and vitamin cofactor
(folate, vitamins B6 and B12) intake {437}
• alcohol: relationship unclear {375}
3. Pathologic
• vitamin deficiency: increased homocysteine
concentrations {10}
• renal disease: increase correlated
with increasing serum creatinine {81}
• transplantation: increased levels {149, 435}
• post stroke: transiently decreased levels {341}
• severe psoriasis: elevated levels {438}
4. Medications
• oral contraceptives/hormone replacement:
decreased levels {269}
• corticosteriods: increased {159}
• cyclosporine: increased {393}
• smoking: increased {336}

Abstracts of Interest
Serum total homocysteine and coronary heart disease in middleaged
British men.
IJ PERRY, H REFSUM, RW MORRIS, SB EBRAHIM, PM UELAND, AG SHAPER.
D E PA RTMENT OF PRIMARY CARE & POPULATION SCIENCES, ROYAL FREE
H O S P I TAL SCHOOL OF MEDICINE, LONDON, AND DEPA RTMENT OF CLINICAL
B I O L O G Y, UNIVERSITY OF BERGEN, NORWAY.
Serum total homocysteine (tHcy) levels are inversely associated with dietary intake of folic acid and B vitamins. Raised tHcy levels have been linked with coronary heart disease (CHD). We have examined the association between tHcy concentration and the subsequent risk of CHD, using a nested case control study design, within a prospective study of cardiovascular disease in British men. tHcy concentration was measured in serum samples, stored at entry to the study, from 110 incident cases of myocardial infarction and 118 controls. Cases were randomly sampled from events which occured after the first five years of follow-up. Cases and controls were frequency matched by town and age group. Levels of homocysteine [geometric mean (95% CI)] were significantly higher in cases than controls: homocysteine 13.5 (12.6 – 14.3) μmol/L vs 11.9 (11.3 – 12.6) μmol/L; p=0.005. There was a graded increase in the relative risk (odds ratio; OR) of CHD in the 2nd, 3rd and 4th quartile of tHcy (OR 1.4, 1.9, 2.2; trend p=0.006) relative to the first quartile. Adjustment for age, town, social class, body mass index, smoking, physical activity, alcohol intake, hypertensive status, serum cholesterol, and serum creatinine did not attenuate this association, (OR 2.1, 2.3, 2.7; trend p=0.04). tHcy levels were higher at baseline in men with evidence of pre-existing CHD and (as expected) adjustment for this factor attenuated the linear association between tHcy and subsequent events, trend p=0.07. The findings suggest that homocysteine is an independent risk factor for CHD
with no threshold level.
Reprinted from Heart, Volume 75 /Number 5 (Supplement 1), May 1996.
Homocysteine and Coronary Atherosclerosis
ELLEN L. MAYER, MD, DONALD W. JACOBSEN, PHD, KILLIAN ROBINSON, MD,
FACC, CLEVELAND, OHIO
The conventional risk factors for premature coronary artery disease include smoking, hyperlipidemia, hypertension, diabetes and a positive family history. However, many patients have precocious atherosclerosis without having any of these standard risk factors. Identification of other markers that increase the risk of coronary disease may improve our understanding of the pathophysiologic mechanisms of this disorder and allow the development of new preventive or therapeutic measures. An elevated plasma homocysteine level has recently received greater attention as an important risk factor for vascular disease, including coronary atherosclerosis. This review discusses the biochemistry of homocysteine and the related metabolic importance of folate, vitamin B6 (pyridoxine) and B12 (cobalamin) as well as a number of essential enzymes. The major factors that influence homocysteine concentration are genetic, nutritional and pathologic.
There is a large body of experimental and clinical evidence for high plasma homocysteine to be a risk factor for vascular disease, including coronary atherosclerosis.
Excerpted from Journal of the American College of Cardiology 1996;27:517-27

An important meta-analysis by Boushey et al in 1995 further quantified the magnitude of risk. In their analysis of all major studies available at that time, they found a linear, independent risk  for increments in homocysteine. There were no levels above or below which an incremental rise in homocysteine did not affect cardiovascular risk. Specifically, every 5 μmol/L increment in homocysteine was found to be associated with odds ratios of 1.6 for m e n ; (95% Cl 1.4-1.7) and 1.8 for women; (95% CI 1.3-1.9) for coronary artery disease.

Cystathionine beta synthase (CBS) catalyzes the reaction taking homocysteine to cystathionine. This enzyme requires pyridoxine as a co-factor and is an integral part of the transsulfuration or
pyridoxine – dependent pathway. 33 distinct mutations have been identified with heterozygosity occurring at a prevalence of 0.5-1.5%. The majority of heterozygotes will have normal fasting homocysteine levels, but can be detected with a methionine load test.

Hyperhomocysteinemia is a Biomarker of Sulfur-Deficiency in Human Morbidities

Yves Ingenbleek
Laboratory of Nutrition, University Louis Pasteur Strasbourg, France
The Open Clinical Chemistry Journal, 2009, 2, 49-60

Abstract: Methionine (Met) is crucially involved in the synthesis of S-compounds endowed with molecular, structural and functional properties of survival value. Dietary Met may undergo transmethylation processes to release homocysteine (Hcy) which may either be regenerated to Met following remethylation (RM) pathways or catabolized along the transsulfuration
(TS) cascade. The activity of enzymes governing RM and TS pathways is depending on pyridoxine, folate and cobalamin bioavailability. Dietary restriction in any of these watersoluble B-vitamins may lead to hyperhomocysteinemia (HHcy) causing a panoply of cardiovascular disorders. Taken together, the vitamin triad only affords partial account of Hcy variance, prompting the search for additional causal factor(s). Body composition studies demonstrate that nitrogen (N) and sulfur (S) maintain tightly correlated concentrations in tissues of both healthy subjects and diseased patients. Any morbid condition characterized by insufficient N intake or assimilation, as seen in protein malnutrition or intestinal malabsorption, reduces body S accretion rates. Excessive urinary N-losses, as reported in acute or chronic inflammatory disorders, entail proportionate obligatory S-losses. As a result, lean body mass (LBM) undergoes downsizing and concomitant depletion of N and S body stores which depresses the activity of cystathionine-􀀁-synthase, thereby promoting upstream accumulation of Hcy and overstimulation of RM processes. HHcy thus appears as the dark side of efforts developed by S-deprived patients to safeguard Met homeostasis. Irrespective of vitamin-B status, Hcy values are negatively correlated with LBM shrinkage well identified by the serial measurement of plasma transthyretin (TTR). The S deprivation theory fulfills the gap and allows full causal coverage of the metabolic anomaly, hence providing together with vitamin-deficiencies an unifying overview of the main nutritional determinants implicated in HHcy epidemiology.

The Oxidative Stress of Hyperhomocysteinemia Results from Reduced Bioavailability of Sulfur-Containing Reductants

Yves Ingenbleek
Laboratory of Nutrition, Faculty of Pharmacy, University Louis Pasteur Strasbourg, France
The Open Clinical Chemistry Journal, 2011, 4, 34-44

Abstract: Vegetarian subjects consuming subnormal amounts of methionine (Met) are characterized by subclinical protein malnutrition causing reduction in size of their lean body mass (LBM) best identified by the serial measurement of plasma transthyretin (TTR). As a result, the transsulfuration pathway is depressed at cystathionine-beta-synthase (C-b-S) level triggering the upstream sequestration of homocysteine (Hcy) in biological fluids and promoting its conversion to Met. Maintenance of beneficial Met homeostasis is counterpoised by the drop of cysteine (Cys) and glutathione (GSH) values downstream to CbS causing in turn declining generation of hydrogen sulfide (H2S) from enzymatic sources. The biogenesis of H2S via non-enzymatic reduction is further inhibited in areas where earth’s crust is depleted in elemental sulfur (S8) and sulfate oxyanions. Combination of subclinical malnutrition and S8-deficiency thus maximizes the defective production of Cys, GSH and H2S reductants, explaining persistence of unabated oxidative burden. The clinical entity increases the risk of developing cardiovascular diseases (CVD) and stroke in underprivileged plant-eating populations regardless of Framingham criteria and vitamin-B status. Although unrecognized up to now, the nutritional disorder is one of the commonest worldwide, reaching top prevalence in populated regions of Southeastern Asia. Increased risk of hyperhomocysteinemia and oxidative stress may also affect individuals suffering from intestinal malabsorption or westernized communities
having adopted vegan dietary lifestyles.

 

 

 

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A Great University engaged in Drug Discovery: University of Pittsburgh

Posted in Advanced Drug Manufacturing Technology, Automated Cell Processing, BioBanking, Cell Biology, Signaling & Cell Circuits, Chemical Biology and its relations to Metabolic Disease, Disease Biology, Small Molecules in Development of Therapeutic Drugs, Gene Regulation, Genome Biology, Immunodiagnostics, Innovation in Immunology Diagnostics, Intellectual Property, Innovations, Commercialization, Investment in technological breakthrough, Molecular Genetics & Pharmaceutical, Personalized and Precision Medicine & Genomic Research, Pharmaceutical Analytics, Pharmaceutical Discovery, Pharmacologic toxicities, Population Health Management, Genetics & Pharmaceutical, Proteomics, tagged Drug development, laboratory configuration, University of Pittsburgh Medical Center on July 15, 2014| Leave a Comment »

A Great University engaged in Drug Discovery: University of Pittsburgh

 

Reporter and Curator: Larry H. Bernstein, MD, FCAP

 

The US-based pharmaceutical companies have been consolidating and now are moving offshore to reduce taxes and other costs.  A part of the problem has been the large cost of clinical trials, the failure to detect toxicities in the early phases, and late phase failure or drug resistance conferring short term success.  This has been at a rate above 60%.  The result is that Big Pharma is looking to recycling old drugs for repurposing. Whatever success can be obtained from this, there is a larger problem in not having a comprehensive biological understanding of the problems imposed by the complexity on a deeper understanding.  I present here a major university, very well recognized in genetics, proteomics, and experimental pathology engaged in the drug development effort with reasonable promise of successes.

 

Perspective On: A Drug Discovery Lab

As lab manager at the University of Pittsburgh Drug Discovery Institute (UPDDI), Celeste Reese and her team use high-content imaging strategies and work with many other labs both within the university and outside the university on a wide range of projects.

By Rachel Muenz | July 03, 2014

 

We try to use new technologies and approaches and quantitative systems pharmacology (QSP) to complement the traditional drug discovery strategies

 

 

Finding Clinically Relevant Solutions

Hard work, teamwork, and a whole lot of multitasking help this lab overcome a tough economic environment

“We try to use new technologies and approaches and quantitative systems pharmacology (QSP) to complement the traditional drug discovery strategies that are used by the large pharmacy companies,” she explains, adding that, on average, they have seven to ten active projects going on at any given time. “Right now we have a metastatic breast cancer program, a head and neck cancer project, and a Huntington’s disease project. We do some zebra fish modeling, some development of novel HIV diagnostics, liver modeling, and a variety of other things.”

Those projects take place in the institute’s 11,000 square feet of space, which covers two floors of the building the institute occupies and includes a large open lab on the top floor and an imaging lab, automation lab, and tissue culture facility on the floor below. Working in that space are 34 staff, including seven faculty, four graduate students, and five undergraduates, with the rest made up of technical specialists, administrative staff, and Reese herself. As in many other labs, staff members have a wide range of education levels—from high school for the undergrads all the way up to extensive post-doctoral experience for the faculty, Reese says, adding that staff receive quite a bit of training when they begin.

“The university has a lot of training modules that we send people to for such things as chemical hygiene, safety, and blood-borne pathogens, even things like safe shipping,” she says. “Then there are modules like conflict of interest training and research integrity training, which are also provided by the university. In-house, we train everyone on our equipment and on the procedures and protocols that we use within our institute.”

Training the grads and undergrads on those lab procedures is a big part of Reese’s role as lab manager, a task that she considers one of the highlights of the position.

“I really like working with the graduate students who come into the lab,” Reese says. “They always have a fresh perspective and they’re always challenging established protocols. They’re fresh and enthusiastic.”

The Catalyst Express robot is used to load plates onto a high-content imaging platform.It was a similar enthusiasm for science that led Reese to pursue the field in university, which led to a job in a pharmacology lab after graduation, getting her interested in the drug discovery field and—after 14 years staying home to raise her children—eventually brought her to the UPDDI, where she has worked for the past eight years.

“I’ve always loved science in general but then after college I got the job in the pharmacology lab and I just really liked experimental design and problem solving and implementation—which eventually led into the lab management position,” says Reese, who has now been lab manager at the UPDDI for four years.

Because of her enjoyment of experimenting, along with her other management duties of looking after supplies and equipment, Reese also likes to keep a hand in what’s going on in the lab.

“I keep an active role in at least one of the research projects that we have going on,” she explains. “I find that that’s very helpful in the lab management area as well, because I see key things while I’m doing experiments that I normally wouldn’t see on a walkthrough.”

Blocking out the day

Liquid nitrogen cell bank.

 

 

Liquid nitrogen cell bank.For Reese, scheduling chunks of time for certain tasks is critical in ensuring she meets her goals for the day.

“Time management’s key when you’re trying to cover as many roles as it takes to do this job,” she says. “I try to keep the mornings for the lab management tasks and then the afternoons are usually taken up with meetings, experimental design and implementation, or data analysis.”

That means Reese’s mornings typically involve coming in, checking on what’s happening in the lab, looking after the ordering of supplies for the week, and attending to any equipment problems and emails. Along with meetings, her afternoons are usually taken up with running or designing experiments or analyzing data. Of course, the rest of the staff have a variety of different roles.

A few programs and regular inventory checks help keep everything organized.

“One of the big tools we have is a purchasing program that we have developed in-house—an access program that we use and a similar one for equipment reservations and things like that,” Reese says. “We do a weekly inventory. We have two stockroom areas and we have two student workers who go out and stock all the individual work areas for people every day. And then we also have written protocols and established procedures for things like routine equipment maintenance and buffer preparations and such.”

She adds that the main challenge her lab faces is the same one that many other labs face—doing more with less in the current tough economic climate. For her lab, multitasking and teamwork are a big part of solving that issue.

“We just have really talented people here,” Reese says of her staff. “Everybody takes on a variety of roles. Everybody pitches in with things like routine equipment maintenance and … rather than having one person in each job, everybody covers a variety of tasks.” Because of that strong teamwork, Reese finds she doesn’t need to do much to motivate members of the lab.

“I don’t manage people—I just try to lead by example and try to take care of any issues that come up promptly rather than put things off,” she explains. “Everybody’s pretty self-motivated and hardworking here.”

An automated compound storage system is used to store the institute’s screening libraries.

 

six separate tissue culture facilities

 

 

 

 

 

 

 

 

 

 

 

An automated compound storage system is used to store the institute’s screening libraries.

The UPDDI has six separate tissue culture facilities equipped with biosafety cabinets, incubators, and microscopes.

The tech side

Along with the aforementioned high-content imaging, Reese’s lab also uses automated liquid handling platforms, biosensors, microfluidics, and immunofluorescence and fluorescence microscopy, and they are starting to implement 3D cell culture strategies to tackle their many projects.

“These fluorescent proteins react to the physiological changes in the cell in real time,” Reese says of the lab’s work with biosensors. “And [with] microfluidics you actually have a moving system. The system is more clinically relevant— it’s a better model for the in vivo systems.”

By “clinically relevant” Reese says she basically means the center is trying to more closely model what is actually going on in the human body, rather than relying on traditional 2D cell culture models or high throughput methods. That focus on clinically relevant methods is a result of big changes in the pharmaceutical industry in recent years.

Top 5 Instruments in the Lab GE InCell6000 Imaging System Agilent (Velocity 11) Bravo Liquid Handling Platform Thermo Scientific Multidrop Combi Dispenser PerkinElmer EnVision 2103 Multilabel Plate Reader Brooks (Matrical) Ministore Automated Compound  Management System

“In the drug discovery field in general, big pharma has been using the mass-scale high throughput screening for a long time and of course now we’re coming to the patent cliff for a lot of the pharmaceutical companies, when a lot of their moneymakers are going off patent,” Reese explains. “So here, we’re trying to move away from that high throughput screening toward a more high-content [screening] where we’re looking at more clinically relevant methods and QSP approaches for drug discovery.”

And the most interesting work the lab is doing right now?

“I would say the coolest thing we have going on is a liver microphysiology project,” Reese says. “We’re making a liver biomimetic, which will be integrated with other organ biomimetics to create a human-on-a-chip for use as a model for drug toxicity and other kinds of organ analysis.”

Categories: Research-Specific Labs

Tags: Drug Discovery Labs

 

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Life-work in Engineering of Improved Heart Valve

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Atherogenic Processes & Pathology, Bio Instrumentation in Experimental Life Sciences Research, Bioengineering & reverse engineering design, Biomedical Measurement Science, Cardiac & Vascular Repair Tools Subsegment, Cardiac and Cardiovascular Surgical Procedures, Computational Biology/Systems and Bioinformatics, Discovery process, Ecosystems & Industrial Concentration in the Medical Device Sector, Experimental validation, Frontiers in Cardiology and Cardiovascular Disorders, Historical relevance, Intellectual Property, Innovations, Commercialization, Investment in technological breakthrough, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Patents, Personal Health Applications: Tech Innovations serves HealhCare, Technology Advance Assessment of, Valves & Tools, tagged aortic valve leaflets, Percutaneous aortic valve replacement, reverse engineering, TAV, TAVI, Transcatheter Aortic Valve Replacement (TAVR), working life of mechanical implant on July 15, 2014| Leave a Comment »

Life-work in Engineering of Improved Heart Valve

Curator and Reporter: Larry H Bernstein, MD, FCAP

 

An authority and author of the book on cardiovascular valve devices is challenged by patient’s mother to go beyond what is available.  The results are splendid after re-engineering the design to the problem.

 

Reverse Engineering A Human Heart Valve

By Jim Pomager

aortic valve – a remarkable piece of biomechanical engineering

 

 

 

The aortic valve is a remarkable piece of biomechanical engineering. On any given day, the leaflets (or cusps) of a healthy aortic valve will open and close 100,000+ times, allowing the proper amount of blood to flow from the heart to the rest of the body. Over a lifetime, a healthy valve endures more than 3.4 billion heartbeats.

Unfortunately, the aortic valve doesn’t always remain healthy. (What organ does?) According to the American Heart Association, up to 1.5 million people in the United States suffer from aortic stenosis (AS), a calcification of the aortic valve that narrows its opening and restricts blood flow. In the early stages, the disease is often asymptomatic, but as it progresses, it can cause chest pain, weakness, and difficulty breathing. And in approximately 300,000 people worldwide, the condition develops into severe AS, which has a one-year survival rate of approximately 50 percent, if left untreated.

Fortunately, there are treatment options.  The most common and successful is aortic valve replacement (AVR), wherein a mechanical or tissue-based valve is substituted for the diseased valve. For decades, replacement valves were implanted via open heart surgery, which involves an extended hospital stay and months of recovery. But in recent years, a promising new approach has emerged: transcatheter aortic valve implementation (TAVI), also known as transcatheter aortic valve replacement (TAVR). In TAVI, a tissue-based artificial valve is delivered into the diseased heart valve via a blood vessel, rather than through a large incision in the chest.

TAVI has many benefits, the most obvious (and compelling) of which is its noninvasiveness, which means shorter recovery times and faster attainment of quality-of-life outcomes for the patient. Replacement of a transcatheter aortic valve (TAV) can also be a minimally invasive exercise — a second TAV can simply be implanted within the first.

On the other hand, the use of TAVI procedures in U.S. hospitals is not yet widespread (though it is growing rapidly). The longevity of current-generation TAVs also remains unknown because it is an emerging technology, compared to evidence of 15+ years for surgically implanted heart valves. Plus, TAVI is only approved in the U.S. for use in AS patients who are either ineligible for surgical valve replacement or at high risk. (TAVI has been available in Europe since 2007, and clinical trials are underway in the U.S. for its use in intermediate-risk patients.)

What’s really needed is an improved TAV — one that outperforms current transcatheter valves, is as durable as a surgical valve, and operates more like … well, a healthy human aortic valve. Such a valve would open the door to TAVI’s use in the hundreds of thousands of lower-risk (and generally younger) AS patients whose only current option is a surgically implanted valve, and who would rather not have their chest opened.

Now, a man who has dedicated his professional career to studying the aortic valve has invented a new artificial valve design that he says will revolutionize TAVI. And if everything goes according to plan, his TAV will reach European patients in 2015 and U.S. patients soon after. How did he and his startup company design such technology? By reverse engineering the aortic valve.

The Man Behind The Valve

Mano Thubrikar

 

 

 

Mano Thubrikar, quite literally wrote the book on heart valves and heart disease — two of them, in fact. His The Aortic Valve (1989) and Vascular Mechanics and Pathology (2007) are leading textbooks in cardiovascular studies, and the former is widely used as a guide in the design of bioprosthetic heart valves.

After earning an undergraduate degree in metallurgy, a master’s in materials science, and a Ph.D. in biomedical engineering, Dr. Thubrikar spent the first 30 years of his career exclusively in academic research. He studied the aortic valve and bioprostheses from almost every conceivable angle while working at the University of Virginia (UVA) and at the Carolinas Medical Center and the University of North Carolina (UNC) at Charlotte.

But in 2003, Dr. Thubrikar received a phone call that would change the trajectory of his career and set him on the path to develop a novel TAV technology. A woman contacted him to discuss her son, a 35-year-old athlete with a calcified aortic valve. The condition was the result of a bicuspid valve, a congenital condition where the aortic valve has two cusps, rather than the customary three. The man needed a valve replacement, and his only choice was to have a mechanical heart valve surgically implanted. However, the surgical valve meant he would have to stay on anticoagulants for the rest of his life, effectively ending his athletic pursuits. Dr. Thubrikar informed the mother that there just weren’t any treatments available that would allow her son to continue his active lifestyle.

“Didn’t you write the book on the aortic valve?” she asked. “Why didn’t you make a valve that my son could use?”

The conversation and question deeply affected the researcher. “I went home and was so disturbed,” he told me during a recent visit to his office. “I talked to my wife and said, “You know what? Years of research, writing papers, and giving presentations — that’s done. I now need to make a heart valve.”

Soon after, Dr. Thubrikar left Carolinas Medical Center to embark on his new mission. He joined artificial heart valve pioneer Edwards Lifesciences as a Distinguished Scientist, but left after it became clear that the company’s plans for him didn’t align with his own.

So in 2007 — coincidentally, the same year Edwards launched the first commercially available TAV device — Dr. Thubrikar returned to academia, joining the staff at the South Dakota School of Mines & Technology. There he spent the next three years working on a new artificial valve design — one based on decades of research on the physics behind the human aortic valve.

Looking To The Human Body For Design Output
According to Dr. Thubrikar’s research, the natural aortic valve follows four strong design principles for maximum longevity and optimal hemodynamic performance. Those criteria are:

1. A specific coaptation height — When the valve’s three leaflets come together to close the valve, there is some surface-to-surface contact between the leaflets, rather than an edge-to-edge seal. This safety margin helps prevent against blood leakage back into the left ventricle.

2. No folds in the leaflets — Natural aortic valve cusps flex without folding. Folds would crease the tissue and cause unwanted stress on the leaflets, negatively impacting durability.

3. Minimum overall height — Extra height would produce dead space, which can lead to a variety of issues.

4. Minimum leaflet flexion — The human aortic valve manages to open completely with the leaflets moving only 70 degrees, not the 90 degrees you might expect. Again, this improves the valve’s longevity.

“You almost need to be a solid geometry design engineer to understand the math and the equations behind these principles,” he explained. “With these criteria, however, you have design parameters for the aortic valve. The mathematical equations give you the output of how an artificial valve should be designed.”

Dimensions of the natural aortic valve

Dimensions of the natural aortic valve

 

 

Based on these four principles, Dr. Thubrikar reverse engineered the aortic heart valve, developing a new artificial valve design that mimics the aortic valve’s precise geometry. In October 2010, he launched a startup company called Thubrikar Aortic Valve, Inc. to commercialize his new creation, which he calls Optimum TAV and touts as “nature’s valve by design.”

“When someone asks me, ‘How does your valve compare with Edwards’?’ or ‘How does your valve compare with Medtronic’s?’, I say ‘We don’t compare our valve to them,'” Dr. Thubrikar told me. “We compare our valve with the natural aortic valve.”

On the surface, Optimum TAV looks similar to other artificial heart valves on the market, with three leaflets of bovine pericardium tissue mounted on a metal stent-frame. (In fact, the design is often mistaken for another widely used surgical valve.) But according to Dr. Thubrikar, it has a unique combination of features that will help it overcome the major design limitations of current-generation TAVs (if we’re going to compare). Those design limitations include:

• Suture holes in the leaflet body — While all TAVs (including Optimum TAV) are constructed by sewing animal tissue to a metal frame, piercing the flexion zone of the leaflets leads to potential wear. Optimum TAV does not have a single suture hole in the working portion of the leaflet body.
• Blood flow through frame — Some TAV frames are as tall as 5 cm in height, extending up into the aorta once implanted. As a result, blood must pass through the frame to enter the coronary arteries. Proteins in the blood will accumulate on the frame, and can eventually break loose and cause thromboembolisms (blood clots).  Optimum TAV is only 2 cm in height. (Related, the low height of the Thubrikar valve also makes it less likely to require a pacemaker.)
• Thick outer frame — The thicker the frame, the smaller the valve opening will be, allowing less blood to pass through. This opening is referred to as the valve’s EOA, or effective orifice area. The average EOA of a surgical valve is around 1.9 cm², and some TAVs have EOAs as small as 1.5 cm²(technically, a mild form of stenosis). In bench tests, Optimum TAV’s EOA was 2.3 to 2.4 cm². (A healthy aortic valve has an EOA of approximately 2.7 cm².)
• Clipped calcified leaflets — Some current TAVs are anchored to the patient’s original valve using a paper-clip like mechanism. In this design, there is the potential that the TAVs leaflets will come into contact with the old, calcified leaflets during the operation, causing wear. Optimum TAV’s design eliminates the possibility of contact between the leaflets and native valve.
• Paravalvular leakage — In some cases, a space forms between the outside of a TAV and the surrounding heart tissue, and blood can leak through. Optimum TAV has a high skirt to prevent this type of gap from developing. In addition, Optimum TAV’s novel frame architecture allows it to conform to and seal off either a round or elliptical annulus (the ring-shaped base of the original valve). This is particularly helpful in minimizing or eliminating leakage in bicuspid patients, who often have an irregularly shaped annulus.
• Balloon expansion — TAV frames made of stainless steel must be forced open by a balloon. The TAV’s tissue can get caught between the balloon and the frame and potentially tear. Optimum TAV’s frame is made of nitinol, which automatically expands once deployed from the catheter.

 

optimum TAV

 

 

Optimum TAV

“Other technologies have built-in issues,” Dr. Thubrikar said. “To be able to avoid those problems in a comprehensive fashion is no small feat.”

Trial By Fire
During the two and a half years following the establishment of Thubrikar Aortic Valve, Optimum TAV seemed to be moving steadily toward market. The company raised enough funding to get started, primarily from friends, family, physicians, entrepreneurs, and technology industry executives. Patent applications were filed, suppliers were selected, valves were painstakingly produced (by hand, over one-and-a-half to two days each), and preclinical testing began.

Members of the Thubrikar Aortic Valve team

 

 

Members of the Thubrikar Aortic Valve team (left to right): Deodatt Wadke, member of the board of directors and cofounder; Samir Wadke, executive director of business development and cofounder; Dr. Mano Thubrikar, president and founder; Samuel Evans, research engineer II; and Nikhil Heble, counsel, secretary, and cofounder

But the fledgling company was dealt a major setback in April 2013, when a fire destroyed the Horsham, Pa. office building to which the Thubrikar Aortic Valve laboratory had recently relocated (from South Dakota). All of its equipment was destroyed and needed to be replaced. The company had to relocate to nearby Norristown, Pa. Not an ideal scenario for a startup trying to make the most of extremely limited resources.

The company was undeterred by the fire, and the last year has been a successful one for Thubrikar. The company completed most of its preclinical testing (including implants in 12 animals and two diseased human cadaver hearts), reached design freeze on Optimum TAV, filed a provisional patent application for its proprietary delivery catheter, and achieved almost $2 million in total funding. Perhaps the biggest milestone came in August 2013, when Optimum TAV met the International Organization for Standardization’s (ISO’s) durability requirements by surpassing 200 million cycles in a third-party ISO certified laboratory.

The durability testing has continued, and Optimum TAV continues to function beyond 390 million cycles, which approximates 11 years in vivo. Surgical valves typically last anywhere from 12 to 18 years, and Thubrikar expects his valve to last at least that long.

“I would not be surprised if it surpasses the longevity of even the surgical valve,” he said.

The company also received its first institutional investment, from Delaware Crossing Investor Group (DCIG), in 2014. The primary DCIG investor, Marv Woodall, led the commercialization of the world’s first stents as president of Johnson & Johnson Interventional Systems (now Cordis) and was on the board of director of the first TAV company, Percutaneous Valve Technologies (PVT, now part of Edwards Lifesciences). Thubrikar has recruited him as its business advisor.

What Lies Ahead
Like many other developers of novel medical devices, Thubrikar Aortic Valve has decided to take its product to market through Europe initially, given European regulators’ comfort level with TAV and the FDA’s steep requirement for clinical trials. “We have spoken to the FDA and will continue to do so on a regular basis,” according to Dr. Thubrikar. “But they asked for a lot more preclinical testing than the European Notified Bodies to start a clinical trial.”

The company is now working to raise an additional $2 million to $10 million, and expects the granting of its patent for Optimum TAV in 2014. The finances will enable Thubrikar to not only conduct a first-in-human (FIH) feasibility study in up to 15 patients this year, but also to expand to a full European clinical trial of about 65 additional patients in 2015. If all goes well, a 2015 CE Mark for Optimum TAV isn’t out of the question.

However, trial success is vital, since today’s investors — and large companies in search of technology acquisitions — wait for significant clinical data to accumulate before backing a medical device. “We realize that until we actually implant the valve in a patient, other companies will think, ‘You don’t know what can go wrong,'” Dr. Thubrikar explained. “We had one big company say, ‘We will pay you four times as much once the product is in a patient.’ They want you to de-risk everything, to work out all the bugs yourself on your own dime.”

Yet Dr. Thubrikar thinks its only a matter of time until his life’s work finally arrives in the hands of interventional cardiologists, who he said have been “knocking at his door” since he first presented a paper on the technology in 2012. Since then, he has spoken at several of the largest interventional cardiology conferences, and word continues to spread about Optimum TAV. Like many other researchers-turned-entreprenuers, he steadfastly believes that his invention will eventually reach the market, where it can begin helping patients — like the one whose mother contacted him a decade ago.

“If hell freezes over, if we don’t get any money, I don’t care,” he said. “I don’t care how it happens. We are going to make a heart valve. That’s the only mission in my life.”

For more information on Thubrikar Aortic Valve and Optimum TAV, visit http://tavi.us/.

 

 

 

 

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