‘We plan to bring out innovative tailor-made cells for diseases’

Published: July 12, 2008  |  Source: hindu.com
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Chennai: Can you gain anything from someone whose job has not been determined? In sports, the guy who sits on the bench can only sit and watch the game, till he is called for. But, we are in the 21st century and medical science can do wonders, breaking barriers and age-old thinking. So even though a stem cell is a cell whose job is yet not determined, new-age companies are opening new vistas of treatment with them. Here’s the catch: every single cell in our bodies ‘stems’ from a stem cell. Like the Queen in chess, a stem cell can become a lot of things, when it gets the signal. So, here you have a part of your body which can become a skin cell, bone cell, red blood cell, nerve cell, skeletal muscle cell…thought not at the same time.

Stem cell company Stempeutics Research (backed by Manipal Education & Medical Group) is in the forefront of such innovation. Its sprightly President, Mr B. N. Manohar recently came down to Kasturi Buildings for a lunch-hour interaction and opened up a new world of therapy and possible cure for diseases, which conventional medicine cannot cure. “The stem cells used in our experimental therapy are Mesenchymal stem cells, which are derived from your own bone marrow. These are multipotent stem cells that can transform into a variety of cell types, and thereby help in Regeneration and repair of the diseased tissues,” he told Business Line. Limited bone marrow only? He clarifies. “While the initial foray of Stempeutics is in bone marrow derived mesenchymal stem cells, Stempeutics is investing heavily on its R&D to bring out some innovative products (like tailor-made progenitor cells) in the near future based on adult stem cells.” If Stempeutics (http://www.stempeutics.com) is successful then it may revolutionise how treatments are meted out to patients suffering from brain damage, cancer, spinal cord injury, heart damage and even blindness.

All this makes you interested, eh? Catch his interview as he explains different facets of stem cell therapy and how you can benefit from it…

You were with Lucas TVS. What has pulled you in from electrical components to this space?

Personally, my interest lies in handling “New” businesses where things are not defined properly. In early part of my career I handled IT projects (Lucas-TVS/Wipro-GE). Then, I moved from handling projects to managing production and logistics. The first business which I handled was the “Service Business” at Wipro-GE – with no prior experience of handling a service business. I could run it very successfully. This gave me confidence about myself. Then I ran healthcare IT business at Wipro-GE, distance education business at Manipal – all were started from scratch.

Stempeutics – was a co-incidence. MEMG (Manipal Education & Medical Group) was looking for a President for Stempeutics with Pharma/Stem Cell background. Seeing my track record (I think so) option was given to me to head Stempeutics. I did my home work for 48 hours and then accepted the current post. It is really a fascinating field. We can really transform medicine and offer new hope to millions of people.

Tell us what are stem cells?

Human body is made up of various cell types. There are about 210 known distinct human cell types in the adult human body (examples heart muscle cells, thyroid gland cells). A cell type is a specialised Functional form of cell.

Now, stem cells are unspecialised cells that can self-renew indefinitely and also differentiate into more mature specialised functional cells. In humans, stem cells have been identified in the inner cell mass of the early embryo; in some tissues of the foetus, the umbilical cord and placenta; and in several adult organs. In some adult organs, stem cells can give rise to more than one specialised cell type within that organ.

Stem cells that are able to differentiate into cell types beyond those of the tissue in which they normally reside are said to exhibit “Plasticity”. When a stem cell is found to give rise to multiple tissue types associated with different organs, the stem cell is referred to as “multipotent”. Broadly there are 3 types of stem cells depending from the source of origin: Human Embryonic Stem Cells (hESCs), Fetal Stem Cells and Adult Stem Cells.

How does Stempeutics plan to leverage them?

Stempeutics is a stem cell company mainly focused on research, therapeutics and therapy in the field of regenerative medicine. Research at Stempeutics is directed towards acquiring the knowledge and understanding of stem cells and its differentiation process required for the development of therapies to treat human diseases. Stem cell research offers unprecedented opportunities for developing new medical therapies for debilitating diseases and a new way to explore fundamental questions of biology. Stempeutics initial foray is to develop cell based therapeutics using human adult mesenchymal stem cells derived from bone marrow. In future, it is planning to bring out innovative tailor-made cells for various diseases

Currently, Stempeutics is focusing on the following diseases: Critical Limb Ischemia, Acute Myocardial Infarction, Dilated Cardiomyopathy, Spinal Cord Injury, Parkinson’s Disease, Cerebral Stroke, Multiple Sclerosis, Diabetes-Type I, Muscular dystrophy and Motor Neuron Disease.

Against conventional medicine which uses chemical entities or Biotechnology, how does stem cell therapy score?

Stem cell therapy aims at addressing the root cause of the disease rather than the symptoms. For example take Diabetes-Type 1. Stem cell therapy addresses how to re-generate the insulin producing cells and secrete them, whereas conventional medicine just addresses only the insulin deficiency by injecting “insulin” medicine. But as on date, Stem cell therapy is considered an experimental therapy. It is conducted as a pilot study.

Medical and scientific interest in stem cells is based on a desire to find a source of new, healthy tissue to treat diseased or injured human organs. It is known that some organs, such as the skin and the liver, are adept at regenerating themselves when damaged. Recent research suggests that stem cells are a key to these regenerative properties. We believe that stem cells would be a major branch of medical treatments 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, and this would be an ideal supplement for existing medical treatments.

It is a fluid field, isn’t this stem cell business?

No. It is not a fluid field. The basic fundamentals do not change; as our understanding of stem cells deepens, it opens up newer opportunities and avenues in therapies and the routes of administration. We also now understand the process of directed differentiation (in vitro) and are confident that this would only open newer horizons in regenerating hope for unmet medical needs.

Definitions change in a matter of months. Do treatments stay the same, then?

Even though the definition changes, the treatment process remain the same. The regulatory process differs between autologous (refers generally to cells and tissues that are re-implanted in the same individual from whom they come) and allogenic (stem cells that are taken from one person and given to another) treatment from country to country.

There is controversy surrounding stem cells in the Western world. What is all that about?

Stem cell therapies raise many difficult and important ethical issues and concerns. These are expected for any new approach or new therapy involving human experimentation. The source of stem cell is a major ethical concern. The use of embryos is generally not agreed upon especially when fertilisation is performed for the sole use of stem cell research. For those who believe that the human embryo, even at the one-cell stage, has absolute moral value, equal to that of a new born baby or an adult, any embryo research is ethically unacceptable, as it would tantamount to murder.

However the use of leftover embryos from in vitro fertilisation (IVF) techniques is legally allowed in many countries. The embryos used in these cases were created for infertility purposes through in vitro fertilisation procedures and when they were no longer needed for that purpose, they were donated for research with the informed consent of the donor.

There are no controversies on the usage of human adult stem cells for therapeutic purpose.

What about the costs? Are they in line with other hi-tech treatments? To what would you attribute the high-cost: manpower, equipments, or technology?

Stem cell therapy costs are in line with other hi-tech treatments. Sometimes it may be cheaper. For example Deep Brain Stimulation (DBS) used for Parkinson’s disease, or Cardiac Resynchronisation Therapy (CRT) used for Dilated Cardiomyopathy is costlier compared to stem cell therapy. In general, stem cell therapy cost depends upon the type of stem cells used and also the mode of treatment.

At Stempeutics we focus on bone marrow derived (from the patient) human mesenchymal stem cells. Human mesenchymal stem cells are 100 per cent safe and can rapidly grow in culture without losing their stemness. We have tied up with leading hospitals for stem cell therapy.

Hospital charges the patients for the treatment. Stempeutics provides necessary services to the hospitals – like stem cells isolation and up-scaling in a clean room Environment, extensive quality control checks, training and support in designing the clinical protocols.

For charged patients, hospital charges approx Rs 3 lakh for the entire treatment. This charge includes archival of patient’s mesenchymal stem cells for 10 years. The main cost on the therapy is on stem cells upscaling and quality control in a 10K clean room environment and the also on the surgery for stem cells transplantation.

Has Stempeutics been able to cure or improve conditions of a patient with stem cell treatment?

Yes. We are able to improve quality of life of many patients. While we have seen 100 per cent safety, efficacy varies from patient to patient depending upon the disease type and disease status. We have seen very good results in many diseases and also moderate to no improvements in certain diseases.

Wherever we have seen moderate/no improvements we are reviewing our clinical protocols with the experts to see how we can improve the efficacy. Sometimes we go back to bench and do further research on the related stem cell science.

Outside India, there is a lot more happening on the stem cells therapy part.

The global market for stem cell therapies is expected to be $20 billion by 2010. Adult stem cell therapy currently dominates the global stem cells market with a share of almost 58 per cent. There are almost 30 prominent adult stem cell companies in the world.

Majority of the companies are based out of the US, followed by the EU; Israel, Thailand, Canada and Australia also have significant presence of adult stem companies. Prominent stem cell companies outside India are Osiris, Organogenisis, Genzyme, Cytori, Aastrom, Theravitae etc.

How are Indian companies faring in comparison to others outside?

India is lagging behind on research and clinical trials compared to other countries. Very few patents (less than 10) and no Drug Controller General of India (DCGI) approved clinical trials on stem cells!!

Stempeutics is waiting for the DCGI approval of two clinical trials. While the expected current stem cell therapy market in India is approx $540 million and expected to grow rapidly, there are only a few dedicated companies focusing on real research and clinical trials. Also we believe Government needs to be proactive in giving fast track approvals for clinical trials (like the FDA does in the US) and allocate sufficient budget for stem cells research.

Stempeutics is supposed to be working on two medicines…

Stempeutics’ goal is to bring out stem cell based drug in the near future using mesenchymal stem cells. Towards this goal, Stempeutics has submitted two proposals to the DCGI: One for treating the heart – Acute Myocardial Infarction (also called as heart attack) and the other for treating the leg – Critical Limb Ischemia (CLI is a severe obstruction of the arteries which seriously decreases blood flow to the extremities and then progresses to the point of severe pain and even skin ulcers or sores).

We had several rounds of discussion with the DCGI and the Indian Council of Medical Research (ICMR). We hope to get the approvals in the next three months. In case the trials are approved by DCGI, then we expect to bring out the medicine some time in 2010, and it will be available off the shelf.

At the same time, Stempeutics is also preparing to study more diseases for clinical trials in Malaysia. This project will be executed from Stempeutics Malaysia.

Do you think heavy expenditure makes stem cell therapy out of reach? What should be done to make it more reasonable in terms of cost?

Stem cell business requires heavy investment. Investments in creating a world class lab for stem cell production, investments in R&D, investments in animal studies, investments in clinical trials and so on.

But we believe that once we have an “allogenic” product – then the cost of treatment becomes very less and it will be affordable by a common man.

Today the treatment is “autologous”. It takes about 4 to 5 weeks to make the stem cells medicine ready for each patient in the lab and cost associated with it is high.

But once we move towards “allogenic” – meaning the stem cells originates from a healthy donor, and then we can use large scale production techniques. This reduces the production cost and makes the therapy affordable. Stempeutics has the competency to do large-scale upscaling. Stempeutics has patented the isolation and upscaling process.

How has the support from the Indian Government or regulators been to this new field?

The ICMR has prepared a draft of guidelines for stem cells research and therapy. We are supposed to follow these guidelines for stem cell therapy. It has not become a law so far. The draft guidelines await the parliamentary nod.

As mentioned earlier Government needs to create a separate task force on stem cells research and therapy and see how India can leverage its intellectual talent and become a global leader in this field.

In Malaysia we are getting excellent support from the Malaysian Biotechnology Corporation. It provides seed funding, R&D funding and export funding for start up companies (BioNexus status companies). Also, it provides 10-year tax sop from the year the company starts making profit, duty exemptions and a host of other benefits for promoting stem cell companies.

We believe that the Indian Government should provide these benefits to stem cell companies based on certain evaluation. Also as for stem cell clinical trials, the Government needs to think of fast track approval process considering it as “orphan” drug status – like what the FDA is doing in the US.

Tell us about your future outlook in this space in India. How do you want to plan your company’s growth?

While the initial foray of Stempeutics is in bone marrow derived mesenchymal stem cells, Stempeutics is investing heavily on its R&D to bring out some innovative products (like tailor-made progenitor cells) in the near future based on adult stem cells. It is also investing money on its long term goal of leveraging human embryonic stem cells for therapeutics purpose.

Towards this goal four human embryonic stem cells lines have been established. Also Stempeutics is focusing on establishing a stem cell platform for drug screening and toxicity studies for the pharma companies. We want to become an undisputed leader in the stem cell area in this part of the world. We are also looking for strategic partners including acquisitions to accelerate our growth.

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D.Murali and Kumar Shankar Roy
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