Stempeutics, the stem cell arm of the Manipal Health Systems, part of the Manipal Group, has invested Rs 4.5 crore to set up the country's first stem cell product manufacturing facility at Manipal near Mangalore in Karnataka.
The facility spans an area of 4 lakh sq ft and will be ready in the next 16-18 months. Meanwhile, it has also submitted a proposal to the Drugs Controller General of India (DCGI) for the human trials with allogeneic stem cell products. The Indian Council of Medical Research (ICMR) will assess the proposal after which the DCGI will give the consent. The company has already completed pre-clinical and pilot studies and on the basis of its report, it is gearing up for clinical trials. The adult stem cell therapy from the company is expected to launch regenerative medicine with products to assist in treatment of chromic diseases.
The company has outsourced the service of validating the products to the clinical research organization of the Manipal Group, Manipal AcuNova to conduct multi-centric trials in the country. Feasibility studies have been completed and within a fortnight investigators' meet will be held to train the personnel on the conduct of the trial.
The trials are expected to commence in November. The studies will now scientifically ascertain the efficacy of the allogeneic stem cell products for treatment of myocardial infraction (MI), leg ischemia, cerebral stroke, and multiple sclerosis, Dr Satish Totey, chief scientific officer, told Pharmabiz. The company is also making arrangements for a clean room facility at its hospital located on the Mysore Road, Bangalore for the preparation of the products, he added.
Manipal Hospital had succeeded early this year to treat a Parkinson's disease case with stem cell therapy which was a first-of-its-kind in the country. Autologous stems cells were retrieved from the bone marrow of the patient who was suffering from the degenerating disorder for the last 15 years. The patient had shown fast recovery in symptoms and the medication for Parkinson's disease has been withdrawn.
Following the success of the treatment with stem cell, Manipal Hospital has 400 patients lined up for treatment and is booked till 2009 for Parkinson's disease. "We need to speed up the clinical trials to bring out products at a faster pace, stated Dr Totey.
Recently the Manipal Institute of Regenerative Medicine was commissioned to offer a two-year post graduate degree in Regenerative Medicine. Since stem cell is at its nascent stage, it is an important area in cell biology. MIRM will not only to prevent shortage of qualified manpower but be base for basic research in stem cells which will be taken over by Stempeutics for advanced research, stated Totey.
Globally, Osiris Therapeutics, Inc. has been working for the last one and half decades to develop and commercialize cellular therapies based on stem cells isolated from readily available adult bone marrow. There are ample scientific evidences proving that stem cells provide treatments for many disease conditions. US FDA has also permitted the company to conduct phase III trials using Allogeneic Mesenchymal stem cells.