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Thread: Indian stem cell research takes human leap

  1. #1

    Indian stem cell research takes human leap

    Anyone knows about this company?

    About the stempeutics co:

    Indian stem cell research takes human leap

    Clinical trials on humans are set to start in February 2007. Stempeutics, a stem cell company will conduct trials in the areas of myocardial infarction, spinal cord injury and limb ischemia.
    "We have finished a pilot study in these areas and have found the results to be very good." said Dr Satish Totey, chief scientific officer, Stempeutics.
    The one-year-old company is accredited by the Indian Council of Medical Research (ICMR) and has its facilities based at Manipal Hospital, Bangalore. The trials will take place in five hospitals across the country and will be completed in one year.
    "We are following the US Food and Drug Administration (USFDA) guidelines for the pre-clinical studies. We will submit our data to the Indian Council of Medical Research and Drugs Controller General of India (DGCI) after the trails in Stage I and II. Once the drugs are ready, we wish to provide them in an injectable form at a very affordable price. We are planning to set up a facility in Bangalore where we can produce these stem cells and provide them to 300 tertiary hospitals once it is approved,'' said Dr Totey.
    While research on the use of stem cell for other diseases - such as osteoporosis, multiple-syrosis, diabetes, stroke, Parkinson's, breast cancer and some cardiac related problems - is already on, clinical trials for these will happen at a later stage. International collaborations too may be required for some of these trials.
    Dr Totey said that human embryonic stem cells will also soon be available in India for research and the research project at Stempeutics will be funded by the Centre's Department of Biotechnology.

    (Indian Express, 26.11.2006)

  2. #2
    Senior Member Leo's Avatar
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    Jul 2001
    Yankton, South Dakota
    Hi Wise, or if anyone else knows,

    What's the scoop on this group Indian Council of Medical Research (ICMR)?

    Sounds like India's version of our FDA?

    I know Wise you've mentioned something before about how India could be one of the countries that could do a big trial for various reasons.

    The sckeptic in me worries the ICMR is just a rubber stamp org?


    2010 SCINet Clinical Trial Support Squad Member

    "You kids and your cures, why back when I was injured they gave us a wheelchair and that's the way it was and we liked it!" Grumpy Old Man

    .."i used to be able to goof around so much because i knew Superman had my back. now all i've got is his example -- and that's gonna have to be enough."

  3. #3
    Senior Member Leo's Avatar
    Join Date
    Jul 2001
    Yankton, South Dakota
    Wow, manouli

    This does look promising, their going into phase 2 trials. Will some of you others look this over.

    Would be interesting to hear what Dr. Totey means by very good results from the trial that ended Nov. 06, his email is on the web site.

    could be their recruting for phase 2

    2010 SCINet Clinical Trial Support Squad Member

    "You kids and your cures, why back when I was injured they gave us a wheelchair and that's the way it was and we liked it!" Grumpy Old Man

    .."i used to be able to goof around so much because i knew Superman had my back. now all i've got is his example -- and that's gonna have to be enough."

  4. #4
    Quote Originally Posted by Leo
    Wow, manouli

    This does look promising, their going into phase 2 trials. Will some of you others look this over.

    Would be interesting to hear what Dr. Totey means by very good results from the trial that ended Nov. 06, his email is on the web site.

    could be their recruting for phase 2
    dr Totey works at Manipal hospital in Bengalore, which is a very renowned hospital. I went there last year in April to make an interview. At that time, there was no mention of the new company, although the trials had started already. I do not know if different trials are planned now, but at that time, it was bone marrow stemcells. I have not seen the results, but remember that they were planning some next steps, among others some tagging of the cells to be able to trace the cells after implementation.

  5. #5
    Senior Member
    Join Date
    May 2005
    All eyes towards India.

  6. #6
    Quote Originally Posted by Jawaid
    All eyes towards India.
    Well , i agree, but beware the fact that the first trial, as far as I know, was carried out on patients with chronic injuries, but very recent [a few months after injury]. So, I think that many more trials are actually necessary to assess results. because improvement recorded could come from natural recovery.
    So, as usual, more information will be needed before drawing any conclusion !

    Still, it's nice to see that trials are carried out a bit everywhere, well, hoping that the same trial is not carried out 20 times at different places of the globe, which is my fear !

  7. #7
    Quote Originally Posted by Leo
    Hi Wise, or if anyone else knows,

    What's the scoop on this group Indian Council of Medical Research (ICMR)?

    Sounds like India's version of our FDA?

    I know Wise you've mentioned something before about how India could be one of the countries that could do a big trial for various reasons.

    The sckeptic in me worries the ICMR is just a rubber stamp org?


    The Indian Council of Medical Research (ICMR) is a semi-governmental organization that is funded by the Government of India through the Ministry of Health & Family Welfare. The governing body of the council is presided over by the Union Health minister, assisted by a Scientific Advisory Board that includes eminent experts from many organizations. The mission of the Council is to promote biomedical research through intramural and extramural research. The Countil has 21 "Permanent Research Institutes/Centres" that are located in different parts of India. So, the ICMR is a little bit like the NIH. It has peer review and many advisory groups and organizes research projects but I don't think that they are the treatment or product certification agency.

    There is a race between China and India in terms of US-approved drug manufacturing sites but this is from the perspective of carrying out clinical trials in India for US FDA approval. Because of the lax state of clinical trial regulations in India, many pharmaceutical companies have been doing their clinical trials in India. I have heard that over 90% of the international clinical trial contracts by large pharmaceutical companies have been going to India.

    India does not have a federal government agency like the US Food and Drug Administration (FDA). In 2005, the Indian Health Ministry recommended setting up an autonomous Drug Control Authority of India (DCAI) that will be patterned after the US FDA (Source). An organization called Central Drugs Standard Control Organization (CDSCO) is already in place with a national and regional structure and is responsible for approving clinical trials and drugs, as well as imports and bans of drugs. Some states also have organizations called the Drugs Regulatory Authorities (DRA) that control and monitor the quality of drugs on the market. There have been many calls for a single national agency called the National Drug Authority (NDA) and various Regional Drug Authorities (RDA's).

    An organization called DCA (Drug Control Authority) apparently exists and struggles to monitor drug quality in India and is chronically understaffed and underfunded. They are responsible for regulating some 20,000 registered pharmaceutical manufacturing units (Source).
    The drug regulation situation in India is in terrible shape. In one study, 10.4% of essential medicines samples collected failed assay analyses and 13-18% of drugs tested from 1996-2001 were substandard (Source).

    On February 5, 2007, the Indian cabinet approved the health minister proposal to establish the Central Drug Authority of India (CDAI) which would move the licensing authority for drugs from states to the national government. However, this is still at a proposal stage.,prtpage-1.cms

    Last edited by Wise Young; 02-06-2007 at 10:52 PM.

  8. #8
    Senior Member rvr's Avatar
    Join Date
    Jul 2003
    socal, usa
    kinda like our chemical industry selling leftover pesticides banned here to 3rd world countries... sure beats paying to have it disposed of properly, and worst case - settlements overseas are a bargain compared to here.

    so now india is our human pharma test lab? cool. I guess the movie "the constant gardener" put africa out of the business/too much into the spotlight.... either way, sure beats dealing w/a responsible agency, or a pack of PI lawyers I suppose - assuming the moral issues don't keep you up at night

    I just hope they have some quick successes before it gets shut down or something bad happens to anyone and they get reincarnated as an angry FDA official, ha!

  9. #9
    The following discussion illustrates what India is going through. They have regulations but nobody to enforce them. It is not clear that local IRB's have sufficient strength and knowledge to protect patients. When dealing with very poor people, the issue of money being an unethical incentive is not trivial. What choices do the poor people have? If the choice is between have no care and a risky experimental treatment, that is an unethical choice.
    Clinical Trials - Part III: ‘India is being projected as a global hub for clinical trials’

    By Sandhya Srinivasan

    Dr Vasantha Muthuswamy, who helped draw up the guidelines for biomedical research in India, discusses the difficulties of ensuring that the trials being conducted in the country do not risk the lives of Indians

    She has been called the Queen of Bioethics. Dr Vasantha Muthuswamy, head of basic medical sciences at the Indian Council of Medical Research, was responsible for coordinating the ICMR’s guidelines for biomedical research, finalised in 2000. Dr Muthuswamy was a keynote speaker at Indian Journal of Medical Ethics’ National Bioethics Conference held in Mumbai in the last week of November. She spoke about the difficulties of ensuring that the hundreds of trials being conducted in India do not risk the lives of Indians. Excerpts from the interview:

    We keep reading reports of unethical research. The latest seems to be clinics advertising stem cell procedures. We also read that the ICMR is aware of such things but has no control over them.

    We are a research organisation and have issued guidelines (ICMR: Ethical guidelines for biomedical research on human subjects, 2000). But we are not a policing authority and we have no legal authority to take any action against anybody. Even if the guidelines become law, there will have to be someone to implement the law, and this authority may or may not be the ICMR.

    The Drugs Controller General is the regulatory authority for clinical trials. Schedule Y of the Drugs and Cosmetics Act applies to trials of new drugs, but permission must be sought from the DCGI for other trials as well, of drugs which have received approval in other countries but have to be marketed in India.

    But there are laws governing research in India. Under the Drugs and Cosmetics Act all trials in India should follow the ICMR guidelines of 2000. The Medical Council of India (MCI) Act, amended in 2002, states that all research in India carried out by physicians has to follow the ICMR guidelines. So there is indirect power to enforce our guidelines.

    The Drugs Controller doesn’t have any responsibility for stem cell research. We drafted the stem cell guidelines at the request of the Drugs Controller. But now he says that the DCGI comes into the picture only when there is a tangible product; the stem cell is biological tissue so it comes under the purview of research. So it has to be done under the ICMR. We developed guidelines for stem cell research in 2002 and put them on our website. We have now revised these in consultation with the department of biotechnology and the final guidelines should be out by the end of this year. We have suggested a national apex body for cell-based therapy with membership for all scientific agencies.

    What regulatory role does the ICMR play in research?

    The ICMR has a mechanism of review for its own institutions, and so do other government agencies. The problem is with the private labs. There is no one supervising them. If we are funding the research then we do supervision. If we are not giving funding, then there is nothing. Now, if there was registration of all research …

    Which agencies have control over different aspects of supervision of a trial?

    Every doctor is governed by the MCI Act. Any doctor doing wrong in a trial or in practice can be prosecuted. The hospital can be closed. The MCI Act is very strong, the MCI has the power to take punitive measures. Whether they are using the power or not, we cannot say.

    The Drugs Controller has authority over any clinical trial for which DCGI permission has been sought and functions under the Drugs and Cosmetics Act. (Trials of recombinant or biotechnology products come under the Environmental Protection Act and the Department of Biotechnology and the Ministry of Environment have a regulatory role.)

    But if someone did a trial without asking the Drugs Controller because it is an approved drug and something goes wrong then the Drug Controller will not come to know.

    It has to come to their attention in some way…

    That’s right, somebody has to make a complaint to them. But they have the power on hearing or reading a report, they can institute an inquiry.

    People may have the power to act but they don’t take action because they are under-resourced…

    Lack of resources is always a problem. They also feel that unless a complaint comes they cannot take action on their own.

    People ask whether participants in some of these trials are able to give informed consent to participate.

    If you look at the quality of informed consent in the whole country, you will see that it is suspect. Who really explains trials to participants, except in a few centres? We are trying to improve the whole system, the informed consent process, so that people are able to take the time to explain to participants. If you look at it, generally (the doctor/ researcher) will say, “We are doing this treatment, we are going to use this medicine, we think it will work,” and immediately (the patient/ participant) says, “Yes we agree.” And that is the reality of the situation.

    A lot of ICMR research is done in public hospitals on people who don’t have any options. The ICMR’s guidelines do define a vulnerable population, but this is open-ended. I would characterise all public hospital patients as vulnerable populations.

    Whether it is the public sector or the private sector where we think the patients are more knowledgeable, the situation is the same. Patients think doctors are doing something for their good.

    I don’t think there is any difference between public and private institutions. The understanding of the whole thing is the same. Since we are a government institution, we do the trials at the hospitals which are attached to us … we are also doing this in private hospitals…. The ICMR is a funding agency and trials are done in hospitals where we do give funding, so private institutions are also involved. But we tell them the procedures -- ethics committee approval, informed consent, and so on.

    This country is changing, a lot of improvement has taken place, but we have a long way to go.

    There are a number of regulatory changes in India encouraging clinical trials here. What are the implications of such changes?

    Schedule Y of the Drugs and Cosmetics Act was amended in 2005. Earlier, we required that all foreign drugs be retested at one phase below the highest phase of testing abroad. Now parallel global clinical trials have come. Schedule Y now permits concomitant phase 2 and phase 3 trials. India can become part of global trials. But even then phase 1 has to be repeated for safety.

    But if we become part of a global trial, a part of a global movement to develop drugs, we can demand an affordable price. So if a new anti-malarial drug is developed by a multinational company, India is part of the global trial; India can have a claim on it.

    What proportion of these new drugs is relevant to India?

    We will never approve drugs not relevant to India, but how can you say a drug is not relevant to India? All drugs are needed. We have more cancer cases in India than in other countries. We are going to be a diabetic capital even as we struggle with malaria, etc.

    What do you fear?

    The fear is that India is being projected as a global hub for clinical trials. Will the ethics committees of each institution be strong enough? For example, will they understand the implications of post-trial benefits? Now the pharmaceutical industry will have its strategies, like selecting 30 centres with 10 cases each to arrive at the statistically valid sample of 300, but it is invalid per centre. Will the local institutional ethics committee have the power to ask the right questions?


  10. #10

    Clinical Trials - Part IV: Rogue research in the guise of stem cell therapy

    By Sandhya Srinivasan

    The stem cell therapy industry is booming in India, without regulation of any kind. Unorganised, unscientific ‘research’ is being passed off as therapy. Some of those offering stem cell therapy in India today may be preying on the desperation of seriously ill patients likely to agree to unknown risks

    The newspapers are filled with reports about the miracle cures of stem cell therapy. In November 2005, former Chhattisgarh Chief Minister Ajit Jogi declared that he felt a “remarkable improvement” after the first course of stem cell therapy. What is this treatment, what stage of development is it at, and where does India stand? And what does it say about the kind of research that is being done in this country?

    Perhaps we should take heed of the warnings in an editorial entitled ‘Stem cell therapy: Hope or hype?’ The drive to make the most of the stem cell “boom” may lead to disaster, note Stephen L Minger, Peter Braude and Ruth Warwick in a May 21, 2005 editorial in the BMJ.


    In recent years there have been a number of press reports of unethical practices in stem cell therapy or research in India.

    One of these was a US-funded project at the LV Prasad Eye Institute in Hyderabad, which was doing stem cell work as long back as 2001. The controversial research involved implanting foetal stem cells into patients with retinitis pigmentosa. The only problem: the research was being done only in India. When the institute approached the ICMR for additional funds, it was refused. The ICMR said: “…undertaking clinical trials on Indian subjects for an experiment which was not being conducted on US subjects was not ethical and hence not acceptable.” But it had no authority over privately-funded research and the tissue transplants continued, without ICMR funding. In 2005, the institute was reported to have used transplanted stem cells to treat more than 240 patients with damaged corneas. Two other private hospitals in Hyderabad are doing stem-cell therapy to treat damaged heart muscle. Others apparently plan to start stem cell therapy for cirrhosis and diabetes.

    The stem cell boom is not confined to private clinics. More recently, doctors at the Institute of Immunohaematology, an ICMR centre, used stem cell therapy developed by a UK-based company, Tristem, to treat four patients with aplastic anaemia at Mumbai's KEM hospital. White blood cells were taken from each patient, "transformed", and then re-infused into the patients. The problem: this, too, was an experimental treatment developed abroad, and was being tested exclusively on Indian patients. Further, poor patients in public hospitals were being subjected to questionable research.The trial was stopped after the ethics committee found out that patients' photographs and other details were posted on the company's website. After the press controversy, the company, Tristem, moved to Pakistan where it has been advertising stem cell therapy to treat thalassaemia and other diseases. Such advertisements contribute to the hype "generally nurtured by commercial interests" about this technology, noted Dr Farhat Moazam, chairperson of the Centre of Biomedical Ethics and Culture, Sind Institute for Urology and Transplantation, Karachi. "In the absence of ethical guidelines, Negligible oversight processes at institutional and national levels, and lack of regulation of healthcare services, it is not difficult to imagine a proliferation of clinics and hospitals promising desperate patients treatments for all manner of illnesses by using stem cells," she wrote in a letter to the newspaper Dawn.

    “We want to promote stem-cell technology but not in this scandalous way,” said Vasantha Muthuswamy, head of basic medical sciences at the Indian Council of Medical Research to Nature magazine, referring to the mushrooming of clinics offering stem cell therapy, without any evidence that they were following basic ethical guidelines and scientific practice.

    The new wave
    Guidelines are also becoming necessary as the government starts funding stem cell research in India. For example, in January 2006, KEM hospital in Mumbai announced the imminent opening of a stem cell centre with a grant of Rs 2 crore from the Union department of biotechnology. The centre plans to do work in orthopaedics, anatomy and cardiology. Clinical trials of stem cell therapy will be conducted for patients with certain cardiac problems. According to newspaper reports, stem cells from the patient’s bone marrow will be injected into the patient just before the surgery.

    Private hospitals have also been announcing departments of stem cell therapy. In Mumbai, the Asian Heart Institute specialising in cardiac care announced its stem cell department as well. And a Mumbai-based institution doing eye surgery announced a tie-up with a Japanese institution for retinal stem cell research focusing on age-related macular degeneration.

    In July 2005, a US-based company, Histostem, announced a tie-up with the Maharashtra government to set up a national cord banking centre in Mumbai. The centres reportedly promised to offer “the latest stem cell-based medical treatment in India at affordable rates.” The chief executive office of Histostem said the company planned to invest $ 20 million over the next three years. “We intend to offer medical facilities using stem cell technology for spinal cord injuries, brain strokes, diabetes and bone cancer at much lower costs.” Industries secretary V K Jairath is reported to have said that the Maharashtra Industrial Development Corporation would have an equity partnership with the company, and the company would be entitled to various concessions such as subsidised land, stamp duty concessions and additional floor space index, “the same announced under the government policy”. Histostem also announced a tie-up with the New Delhi-based Apollo Hospitals to jointly develop new therapies using umbilical cord stem cells. Apollo’s inputs include assistance in obtaining umbilical cord blood. According to the news report, over 50,000 people donated cord blood for the company’s $80 million stem cell therapy centre in Korea.

    ICMR guidelines
    In 2002, the Indian Council of Medical Research drew up draft guidelines for stem cell research /regulation in India. This was partly in response to the controversies of stem cell therapy and partly in response to the anticipated growth in international collaborations in this field. The ICMR’s guidelines were preceded by guidelines from the Department of Biotechnology in the previous year, and there has been some confusion on which one of the two apply. However, it is understood that the two departments plan to cooperate to ensure ethical research and practice. Since 2000, the ICMR has had guidelines on all biomedical research; the new guidelines would supplement this earlier document.

    The ICMR draft guidelines discuss stem cell therapy in terms of the source of the stem cell – adult (in bone marrow and certain other tissues), cord blood (in the umbilical cord), foetus and embryos.

    “Realising the potentials of this new technology in modern therapeutics and biomedical research, it is strongly recommended that stem cell research and its clinical applications be promoted in the country.”

    However, it should be regulated properly and new research examined carefully before being approved. There is a need for regulation, and a regulatory body. A central committee will clear all research projects involving embryonic stem cells in the country. This will also survey and approve laboratories where embryonic research will be allowed, and IVF centres from where embryos are sourced.

    The ICMR draft guidelines note that since medical termination of pregnancy is legal in India, foetal stem cells can be obtained easily from MTP clinics, but termination for the purpose of obtaining stem cells is not permitted. Likewise, spare embryos for embryonic stem cells can be obtained from IVF clinics, but embryos should not be produced for the sake of stem cell therapy /research. (In fact, this is a real danger – that women will be coerced or paid to undergo risky procedures in order to produce spare material for stem cell research and therapy, and a simple ban on such practices may be insufficient.)

    The draft guidelines are reasonably general. Among the issues to be considered are whether the product has been obtained with the donor’s informed consent, whether research proposals are reviewed by an ethics committee, the possible commercial value of the product of research, and so on.

    Safety is a major issue, and the guidelines mention regulation of centres doing stem cell work to ensure that they are registered and follow standard practices for preservation of the tissue. As the writers of an editorial in the BMJ in May 2005 note, “The lessons of the premature application of gene therapy, the devastation caused by HIV transmission to people with haemophilia, the clinical and legal problems resulting from hepatitis C infection through blood transfusion, and the crisis caused by bovine spongiform encephalopathy should all be learning opportunities. Expansion of stem cell cultures could allow a single stem cell line to be used for many hundreds, if not thousands of patients, exponentially amplifying the potential risk of disease transmission from a single infected donor.”

    Even these very general guidelines are yet to be finalised. They would be read along with the ICMR’s more detailed guidelines for biomedical research, finalised in 2000. However, the 2000 guidelines are not legally binding, and in any case, there is little or no real regulation of medical practice in India. As a result, public and private hospitals around the country seem to be offering stem cell “therapy”. But is this therapy or some kind of research in the guise of therapy? Do patients know what they’re going in for?

    According to Dr Muthuswamy (as quoted in Nature), since the guidelines were issued, the ICMR has been receiving notification of various stem cell research projects. But many private clinics offering such procedures reportedly did not contact the ICMR at all.

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