Stem cell therapy holds considerable promise as an adjuvant if not as an alternate therapy. But the medical fraternity needs to offer therapy backed by scientific data proving its safety and efficacy opine industry experts.
The research and application of therapies using adult bone marrow autologous and allogneic cell transplant has been in vogue for the last five years. Now the government of India through the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT) had laid down guidelines for stem cell research and therapy in 2007 but now the guidelines which have been further modified after industry input are in the final phase of approval.
Globally with Osaris Inc. which is well on schedule with stem cell products in place to go for Phase IIb and Phase III trials. In India, it is Stempeutics which is part of the Manipal Group which is also awaiting clearance for Phase IIb and Phase III trials is hoping be able to the first or on par with Osaris to introduce the product to treat the Critical Leg Ischemia (CLI).
In the last few years, there has been considerable growth in the stem cell therapies with leading hospitals using stem cells to adopt treatment adhering to patient consent and highest quality practices. These include International Stemcell Services Ltd, Manipal Hospital, Narayana Hrudayalaya, Jain Institute of Vascular Sciences (JIVAS), BGS Global Hospital in Bangalore, Medanta Medicity in Delhi, Sion Hospital in Mumbai PGI Chandigarh among others. There are extensive research efforts on at the CMC Vellore, LV Prasad Eye Institute at Hyderabad National Centre for Biological Sciences, Bangalore, All India Institute of Medical Sciences (AIIMS), at New Delhi and Centre for Cell and Molecular Biology (CCMB) at Hyderabad.
Industry estimates that the global stem cell market in 2010 was around Rs. 900 crore ($20 billion). It is the adult stem cell therapy which is accounts for over 60 per cent of this market. In India the market is valued at around Rs. 500 crore.
Going by the prospects for stem cell applications, the DBT has chipped in Rs. 200 crore to establish the ‘iStem’ in the NCBS campus which will focus on training and basic research. The first dedicated institute for stem cell forms a part of the national ‘bio-cluster’ or an industry interaction platform of which NCBS and the Centre for Cellular and Molecular Platforms (C-CAMP) are part. It will work in co-ordination with the NCBS and C-CAMP to form the Bangalore bio cluster where it will develop technology and enable entrepreneurship initiatives. The effort would also be to comprehend the mechanism of stem cells and its potential to treat degenerative diseases.
According to Dr. Jyotsna Dhawan, dean, iStem, there will be cross fertilization of ideas from the Bangalore-based physical sciences labs and the information technology companies in Bangalore.
Going by the developments so far, we are confident that the stem cell applications for treatment,could be an option for doctors globally to prescribe at least by the year-end, said Dr. Ramananda S Nadig, Chief Executive Officer, Khoday Stem Cell Research & Medical Centre.
According to Dr. Gururaj A Rao, research director, International Stemcell Services Ltd, the stem cell therapy is recognized as a potential therapy option. Going by the success of this option so far, we are now looking to recommend stem cell therapy as a first line therapy for osteoporosis, critical leg ischemia and foot ulcers, he said
“There is still a lot of hot air on stem cell therapies and there is no evidence and scientific base as a relief for many diseases. Therefore there is a huge gap between what is being said and achieved. The rationale needs to be clear more so in many degenerative diseases, like cerebral palsy and motor neuron diseases(MND),” he added.
There are extensive collaborative efforts on to increase the application of stem cells backed by adequate research. These include JIVAS and the Sri Raghavendra Biotechnology (SRB) - Jain Stemcell Research Centre which is carrying out collaboration work on diabetic foot and vascular diseases apart from cartilage regeneration in osteoarthritis, said Dr. Rao.
Stem cell cos on the move
International Stemcell Services Ltd is now in the process of identifying land in the Bangalore to set up a stemcell hospital. It is also looking for acquisitions of small and medium sized hospitals or nursing homes to convert them into a dedicated centre for stem cells therapies.
Stempeutics is currently way ahead in the area of stem cell applications. The company is awaiting the DCGI clearance to carry out the human studies which is Phase IIb and Phase III for critical limb ischemia. In the case of acute myocardial infection, it has completed the preliminary studies and need to seek approval from the DCGI for assess the efficacy parameters with more number of patients. It is now looking to improve this human trial for AMI from the earlier CLI trial for which it hopes to get a consent from DCGI in the next few months.
The company early last year had received investments from the pharma major Cipla which is the marketing partner for the stem cell products. In addition to the two conditions, CLI and AMI, it has applied for clearances for five more disease conditions that can be treated using stem cells, said BN Manohar, president, Stempeutics.
BGS Global Hospitals in Bangalore is applying stem cell therapy in neurological diseases like Parkinson’s Disease, Cerebral Palsy and head injury. However the results in spinal cord injury are not encouraging.
“We would like to scientifically evaluate the outcomes and the benefits in neurological disease where otherwise no cure or relief is possible today with existing medical or surgical treatment. There are many diseases that modern medicine has not been able to provide a cure or surgical relief to the patients.
This problem gets compounded with neuro diseases as the patient gets disabled where the quality of life is significantly affected. This has got additional financial and social implications on the family. Medicine has advanced to this stage only with research and application of innovative ideas both in pharmacological therapy as well as biological therapy. Innovation is necessary in order to discover newer methods of treatment for human welfare,” said Dr. NK Venkataramana, Vice Chairman, BGS Global Hospitals
Ecron Acunova Stem Cell Therapy and Diabetes Centre , a centre for excellence, has pumped in around $1million for beefing up activities.“In order to bring our cumulative experience in areas like stem cell, diabetes, the centre brings together scientific, clinical, regulatory, safety and strategic knowledge together on a client’s problem,” said D A Prasanna, Founder and Chairman of Ecron Acunova
“Despite the ample growth prospects, venture capitalists are still trying to comprehend if it is an area whether it can be worth investing. While there is an increased awareness in the patient population about the option of stem cell therapies. Need of the hour is to proof of concept and government support to clear the guidelines. There is also need for more controlled trials, to asses if the therapy is the option for many degenerative diseases. But the challenge is to bring in individual doctors and hospitals together to work on stem cell therapies,” pointed out Dr. Rao.
There is a tremendous amount of interest in understanding the mechanisms and the therapeutic benefits of the stem cells. So the future research will be in the direction of understanding the stem cell therapeutic benefits and effects and expansion of the various clinical indications, said Dr. Venkataramana.
Overall stem cells is a promising field but it is quite clear now that there are evidently no shortcuts. Therefore a marathon effort is needed to arrive at the final product, said Manohar.
So far adult stem cell therapies have not resulted in any serious threat of malignancies or rejection. But still one needs to keep a watch regularly on safety issues arising from stem cell therapy in the long run, added Dr. Nadig.