Hyderabad, April 8:

The Indian stem cell industry is in a nascent stage. There is potential for fast growth and global players will enter the market through mergers and acquisitions, says a study by YES Bank and the Federation of Asian Biotech Associations (FABA).

At present, the top five players in the Indian private sector space in stem cells are Reliance Life Sciences, Life Cell, Cryobanks India, Stempeutics and Trans-Scell Biologics. Most of the Indian companies are focussed on stem cell banking and research, the study released recently stated.

With the benefits of stem cell therapy growing, it is attracting several organisations and industry to invest, create and commercialise promising technologies. The global stem cell therapy market was pegged at $21 billion in 2010. It is projected to grow to $60 billion by 2015, the study pointed out.

Stem cells are unique as they have the ability to divide indefinitely and give rise to specialised types. Under specific conditions they can be induced to become tissue or organ specific cells with special functions. The main sources of these cells are embryos and adult tissues.

When it comes to treatment, it serves as an internal repair mechanism, dividing to replenish other cells. These characteristics of the stem cells are helping scientists to even tackle difficult diseases such as Alzheimer's or Parkinson's.

The market for stem cells will include specific products, services and technologies to aid in diagnosis to cure.

Though, the report did not give the size of the Indian market, it forecasts an annual growth rate of around 15 per cent, mainly driven by investments from the Government and private players.

The Indian Government has been quite proactive in promoting work in stem cells, especially in clinical trials, basic research and creating applications. The Department of Biotechnology has invested $60 million into stem cell research during 2005-2010.

The National Centre for Biological Sciences, Bangalore, is a major player. Similarly, the Hyderabad-based Centre for Cellular and Molecular Biology has set up a clinical research facility for stem cell technologies with an investment of Rs 24 crore last year. Other important centres for stem cell work are National Centre for Cell Sciences at Pune, LV Prasad Eye Institute, Hyderabad, Centre for Stem Cell Research at CMC, Vellore, National Brain Research Centre, New Delhi and so on, the report identified.

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Stem cells market all set to grow: Study

Public release date: 9-Apr-2012 [ | E-mail | Share ]

Contact: Jill Scoggins jill.scoggins@louisville.edu 502-852-7461 University of Louisville

LOUISVILLE, Ky. To paraphrase Yogi Berra: It's dj vu all over again with a twist.

A University of Louisville researcher known for his prowess at winning competitive grants from the National Institutes of Health has won another one his first for clinical research.

During his 18-year tenure at UofL, Dr. Roberto Bolli has generated more than $100 million in grants for basic research from the NIH. Today, Bolli joined with University of Louisville President James R. Ramsey to announce a new NIH grant he has won for clinical research, a seven-year, $3.4 million grant from the National Heart, Lung and Blood Institute to establish one of seven regional centers across the United States in the Cardiac Cell Therapy Research Network (CCTRN). The network conducts early clinical trials of adult stem cell therapies in patients with heart disease.

"Stem cell therapy holds great promise for treating heart disease, and researchers involved in CCTRN are helping determine how these promising therapies might be most beneficial to patients," said Dr. Sonia Skarlatos, deputy director of the Division of Cardiovascular Sciences in the NIH's National Heart, Lung, and Blood Institute. "This new round of funding is an important step in helping to improve cardiovascular health."

This move from basic to clinical research from "bench to bedside" in medical lingo will test the validity of new therapies by replicating studies in patients at two or more of the network's centers located at UofL, Stanford University, Texas Heart Institute, Minneapolis Heart Institute, University of Florida, University of Miami and Indiana University.

Replicating studies in several locations with a large number of patients is necessary for researchers to ultimately determine which ones can be submitted to the Food and Drug Administration for approval.

"Through the work of Dr. Bolli and his team, the UofL Health Sciences Center continues to fulfill the promise of a great metropolitan research university," Ramsey said. "Success like Dr. Bolli's in conducting basic research lays the foundation for him to conduct clinical studies that will determine the standard of care for the future.

"Clinical trials of new adult stem cell therapies are among the most promising and exciting areas of medical research today, and being part of a national network such as the CCTRN means UofL can bring this cutting-edge medicine to the people of Kentucky and beyond."

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From bench to bedside: NIH grant establishes cardiac clinical research center at UofL

Texas' proposed adult stem-cell regulations, up for approval this week, are under fire for circumventing the Food and Drug Administration and making the experimental therapy commercially available before it's been proven safe and effective.

The criticism of the Texas Medical Board draft policy, developed in the aftermath of Gov. Rick Perry receiving stem-cell treatment for his back problems, is coming from a host of pre-eminent scientists and institutions, including the influential scientific journal Nature and the International Society for Stem Cell Research.

"Texas officials should take the FDA's regulatory power over stem cells more seriously," editorialized Nature. "If the medical board were to act according to its stated pledge to protect patients, then it would make clear the need for clinical validation of adult stem cells before use and rescind the medical licenses of any doctors in breach of rules about using unapproved treatments."

Dr. Irving Weissman of the ISSCR called the draft "a clever way around the FDA's appropriate role overseeing clinical trials." Weissman, director of Stanford University's Institute for Stem Cell Biology and Regenerative Medicine, said the policy violates the ISSCR's guidelines for clinical use of adult stem cells.

The policy, thought to be the first of its kind, would allow Texas doctors to provide the unlicensed therapy as long as they have approval from a review panel that assesses the cells' use for patient safety, as is customary in clinical trials. But unlike most clinical trials, in which experimental therapy is provided free, the policy would allow Texas doctors to charge for it, typically tens of thousands of dollars.

Mari Robinson, executive director of the Texas Medical Board, denied that the proposed policy represents an alternative path than the FDA. She said that in the absence of definitive direction from the FDA, the board simply wants to ensure that "new and expanding areas of medicine" are safe for patients.

"The FDA has provided no definitive statement about the medical use of adult stem cells, including whether it even has jurisdiction if the cells are taken from patients and given back within the state," said Robinson. "The board wants to let the field come forward and grow but in a safe manner."

Robinson, a lawyer, said the courts ultimately may provide the answer about the FDA's jurisdiction. The federal agency last year filed an injunction to stop a Colorado clinic from treating patients with their own stem cells, arguing its failure to comply with FDA regulations "puts the public's health at risk."

Adult stem cells are cells in the body that multiply to replenish dying cells. Though they lack the ability of embryonic stem cells to morph into any kind of tissue, they have shown much promise in recent research treating a variety of conditions. Still, the therapy is mostly in early-stage clinical trials and considered five to 10 years away from FDA approval.

Clinics popping up

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Medical board's proposed stem-cell policy under fire