Stem cells to treat heart attack; stop limb amputation by Stempeutics may be lauched in India in 2 years

Stempeutics Research, a stem cell research company from India’s southern city of Bangalore, could launch the country’s first-ever therapy using adult stem cells to treat heart attack in next two years, reports said.

Stempeutics has completed pre-clinical studies demonstrating the appropriate safety profile of human bone marrow-derived ex vivo cultured adult mesenchymal stem cells in allogenic settings.

Stempeutics is currently doing clinical research to establish the efficacy of the stem cell therapy in acute myocardial infarction (heart attack) and critical limb ischemia.

The injected cells have the potential to induce formation of new blood vessels (neoangiogenesis) in the ischemic limb and by improving circulation, they increase pain free walking distance (PFWD), relieve rest pain, heal ischemic ulcer and prevent or decrease rate of amputation.

Drug Controller General of India (DCGI) and Indian Council for Medical Research (ICMR) – the apex body regulating medical research in India –and the Department of Biotechnology (DBT) under the ministry of science and technology, government of India gave approval to Stempeutics last year to start clinical trials using allogenic mesenchymal stem cells from the bone marrow for these two indications.

Stempeutics’ is considered the first DCGI and ICMR approved clinical trial using adult allogenic mesenchymal stem cells from the bone marrow in India.

A phase 3 study using adult allogenic mesenchymal stem cells is planned to be conducted in India in 2011

Stempeutics is also planning to conduct another phase III study outside India. This second phase 3 is likely to be supportive for the registration of the product in ASEAN countries.

Stempeutics is planning to file new drug application (NDA) in India in the coming years.

The clinical trials are being spearheaded by Manipal Acunova, a Bangalore based CRO.

The multi centre, double blind, randomised and placebo controlled studies are being conducted at various hospitals in India including Bhagawan Mahaveer Jain Heart Centre, Bangalore; Amrita Institute of Medical Sciences, Kochi; Care Hospital, Hyderabad; S A L Hospital and Medical Institute, Ahmedabad; and M S Ramaiah Memorial Hospital, Bangalore ASir Ganga Ram Hospital, New Delhi; M S Ramaiah Memorial Hospital, Bangalore and in Bhagawan Mahaveer Jain Heart Centre, Bangalore.

The patient recruitments for the trial have been completed.

Stem cells are special kind of cells which are unspecialized / undifferentiated, having capacity to self-renew and potency to give rise to different specialized cell types.

Stem cells can be found in the living body (adult stem cells) or in the fetus.

Adult stem cells typically generate the cell types of the tissue in which they reside.

However, a number of experiments over the last several years have raised the possibility that stem cells from one tissue may be able to give rise to cell types of a completely different tissue, a phenomenon known as plasticity.

Examples of such plasticity include blood cells becoming neurons, liver cells that can be made to produce insulin, hematopoietic stem cells that can develop into heart muscle and mesenchymal stem cells have the potency to develop bone, neurons, myocardium, endothelium, muscle tissues etc.

Adult stem cells are more safe and have no ethical issues when compared to embryonic stem cells and therefore, exploring the possibility of using adult stem cells for cell-based therapies has become a very active area of investigation by researchers.

Stem cells offer the possibility of a renewable source of replacement cells and tissues to treat diseases including Parkinson’s and Alzheimer’s diseases, spinal cord injury, cerebral stroke, burns, multiple sclerosis, motor neuron disease, Duchenne’s muscular dystrophy, ischemic heart disease, diabetes mellitus, critical limb ischemia, vision and hearing loss, osteoarthritis, rheumatoid arthritis and many more.

Stempeutics Research Private Limited is a stem cell company developing stem cell based medicinal products, with facilities in Bangalore and Manipal (India) as well as in Kuala Lumpur (Malaysia).

Stempeutics has a pipeline of stem cell therapies for various indications including chronic obstructive pulmonary disease, dilated cardiomyopathy, liver cirrhosis, osteoarthritis and diabetes mellitus.

Stempeuties has obtained MoH, Malaysia approval for cerebral stroke clinical trails.