India Stem Cell Therapy for Limb Girdle Muscular Dystrophy

After receiving stem cell therapy in April, a Nahik-based basketball coach can now confidently ride a bus to Mumbai for his appointments without fear that he might lose his balance.

Diagnosed with a Limb Girdle Muscular Dystrophy (LGMD) when he was 19, Saline Salve can now more easily perform his day-to-day activities unlike in the past months when he cannot even apply shampoo to his hair or flip the pages of newspapers.

LGMD, an incurable disorder which affects voluntary muscles particularly those around the pelvic and shoulder region, is caused by the absence of some proteins in the muscles and leads to muscle degeneration.

In the stem cell therapy he underwent, stem cells were injected around Salve’s spinal cord to form the missing proteins in his muscles. The stem cells will reportedly slow down muscle degeneration.

Dr. Nandini Gokulchandran, head of clinical research at Chemur Cinic Neurogen, says patients who receive stem cells therapies also undergo physiotherapy and occupational therapy as part of their rehabilitation. Salve’s routine of throwing basketballs helps mobilize the stem cells to the areas of the body where they are needed, Dr. Gokulchandran adds.

Salve coaches 14 basketball players who were selected for this year’s state team. He can now spend 12 hours in the field instead of the 4 hours he used to spend before he had his stem cell treatment.

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Illegal Stem Cell Treatments in India
28 October 2010

If you are planning to undergo stem cell therapy in India, it might interest you to know that Indian health authorities have not approved most stem cell treatment for patients. The only stem cell therapy approved for clinical application is for bone marrow treatments. The rest are considered illegal.

According to Indian Express, the government has only approved stem cell research activities but some hospitals and clinics are illegally conducting stem cell treatments.

Says Dr V M Katoch, Director General of the Indian Council of Medical Research (ICMR):

“The current guidelines, implemented in 2007 pertain only to research activities. But many leading private hospitals across the country are clinically implementing treatments that are still in the trial stage, particularly for neurological disorders.

Brain tissue regeneration and many umbilical cord blood cell treatments being practised have not been cleared by the Government of India.”

According to the ICMR Director General, his agency is planning to issue a new set of guidelines that deals with stem cell treatment. “The Clinical Establishment Bill, which deals with clinical aspects of treatment and hospital functioning, is likely to be passed in the winter session. This Act specifically deals with practical aspects of stem cell management, defining what is permitted,” Dr. Katoch says.

India isn’t the only country in the world where illegal stem cell treatments are being conducted. It deserves kudos for recognizing the problem and doing something about it.

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Stempeutics Stem Cell Treatment For Non Healing Wounds: Ongoing Research
01 May 2010

A stem cell company in India is claiming that its clinicial trial for its stem-cell based product, Stempeucel-CLI, has so far shown a “positive efficacy trend”, i.e., an improvement in ABPI (ankle brachial pressure index) & ankle pressure, decrease in number of ulcers and no significant increase in number of amputations. Stempeucel is developed to treat patients with “chronic non-healing wound/ ulcers or gangrene and ischemic rest pain”.

Check out the press release of the company below:
Bangalore April 27th 2010 – Stempeutics Research Pvt. Ltd., a group company of Manipal Education & Medical Group announced today that it has completed the initial Phase I/II clinical trial of its product “Stempeucel-CLI”. This multi centric, placebo controlled, double blind trial was approved by DCGI last year (2009). Stempeucel-CLI is a stem cell based product developed using mesenchymal stem cells derived from donated bone marrow, for Critical Limb Ischemia (CLI) patients. Critical Limb Ischemia term is used for patients with chronic non-healing wound/ ulcers or gangrene and ischemic rest pain. To market its product Stempeutics has established strategic alliance with India’s leading pharmaceutical company Cipla.

The clinical trial product has been manufactured using Indian FDA guidelines under ISO 9001:2008 & GMP compliant lab and the clinical trial has been conducted as per the GCP norms. The outcome of the trial shows (a) No rejection of allogenic MSCs (b) the product is safe & well tolerated and no adverse events attributed to the product and (c) Positive efficacy trend i.e. Improvement in ABPI (ankle brachial pressure index) & ankle pressure, decrease in number of ulcers and no significant increase in number of amputations. The initial trial outcome establishes safety and it requires further study to establish the efficacy.

To market Stempeutics products, Stempeutics has established strategic alliance with India’s leading pharmaceutical company, Cipla. Under this alliance, Cipla is sponsoring upto Rs. 50 crores in Stempeutics in the initial phase for research and development of stem cell based products. Further investment may be considered at a later date. Cipla will extend technical support for production and handle “go-to-market” activities of the product. As part of this deal Cipla gets the marketing rights of the product being developed by Stempeutics.

Speaking about the Cipla-Stempeutics tie-up, Mr Amar Lulla, Joint Managing Director Cipla said “We believe that Stem Cells would be a major branch of medical treatment and would be a standard of cure and practice in the years to come. Regenerative medicine is a rapidly emerging area of biomedical research with enormous therapeutic potential world wide, and this would be an ideal supplement for existing medical treatments. We are very happy to tie-up with Stempeutics because of their R&D strength in developing world class stem cell products starting from basic research, pre clinical studies, large scale upscaling and conducting multi centric clinical studies as per international standards.”

Speaking about the product development & Cipla tie-up Dr Ranjan Pai, CEO, Manipal Education & Medical Group said, “We are progressing well towards our goal of bringing the first stem cell based product to the Indian market in the near future. Stempeutics has done pioneering work in the isolation, up-scaling and large scale production of adult Mesenchymal Stem Cells for therapeutic applications. By far, it is the first stem cell company in this part of the world to come upto this level. On the Cipla tie-up he said that the synergistic combinations of Cipla & Stempeutics are based on the strong values of their founders and powered by their corporate vision, and is poised to bring out novel stem cell based products for mankind and transform India into a global player in stem cell therapeutics”.

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Stem Cell Therapy for Stroke Patients?
05 November 2010

Can stem cells cure stroke patients? Initial results from a Phase I trial study conducted by researchers at the All India Institute of Medical Sciences (AIIMS) suggest that stroke patients can overcome their handicaps with the help of stem cells taken from their own bone marrow and injected back to their antecubital vein [a blood vessel that carries blood from the body back into the heart].

The AIIMS research was first reported last March 2010 by Minister of State for Health and Family Welfare Dinesh Trivedi during the Fifth National Congress on Indian Stroke Association and International Stroke Conference. At that time, the Health Minister said thus:

“Doctors here are trying to treat stroke patients who have suffered paralysis or disability with stem cells. It is in the research stage. The results are expected soon.”

The researchers now have the results of their Phase 1 study and the results are encouraging. According to The Med Guru, of the 12 patients who were included in the stem cell treatment trial, 70 percent “were able to overcome their handicaps and became free of deficits like weakness of limbs and inability to walk”.

The researchers, led by Dr Kameshwar Prasad, will soon be conducting their project’s Phase II with the results expected to be released sometime in June 2011.

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