Stem Cell Therapy and its Trend in India

Excerpts from an interview with Dr. Fraser, Principal Scientist of Cytori Therapeutics Pvt Ltd.

1. What according to you is the current trend of stem cell research in India? How are people warming up to this idea?

India has several research programs underway on stem cells and their benefits. Historically, these have largely been focused on Bone-Marrow derived cells, but, in recent years, more focus has been shifted to other cell sources such as Adipose (fat) tissue which is more easily attainable from a patient and provides cells in far greater quantities. India has the ability to become a leader in Regenerative Medicine and  with the recent formation of the National Apex Committee to oversee Stem Cell Research in the country, we expect that we’ll see a significant increase in the amount of evidence-based research coming out of India.

2. How can India play an active role in world wide stem cell research? Is India really ready for such a revolution?

As I mentioned earlier, India has the ability to be a world leader in regenerative medicine and stem cell research. Indian scientists and the science they produce is widely respected across the world.  However, in order to recognise this potential in the realm, there will need to be an acceleration in the regulatory infrastructure in respects to Stem Cell Research. This field is growing very quickly and it is important for the regulatory infrastructure to keep pace, in order to ensure that patients are protected.

3. Could you throw some light on the importance of Adipose derived stem cell introduced by Cytori? Also, what are its potential benefits?

Cytori Therapeutics’ goal is to provide access to clinical grade Adipose-Derived Stem and Regenerative Cells (ADRCs). ADRCs, sometimes referred to as stromal vascular fraction cells which are a heterogeneous or mixed population of cells found in adipose tissue. This population includes adult stem cells, endothelial progenitor cells, leukocytes, endothelial cells, and vascular smooth muscle cells.

The use of ADRCs is a unique approach and holds key advantages over stem and regenerative cells from other sources. While stem and progenitor cells usually make up less than 5% of all ADRCs, this is 2,500-fold more than the frequency of such cells in tissues such as bone marrow. The abundance of ADRCs in adipose tissue and the ability to easily collect large amounts of adipose tissue via liposuction eliminates the need for tissue culturing. This means that we can easily deliver a patient his or her OWN cells, in real-time. Because this is an autologous procedure, the risk of rejection is virtually eliminated.

Autologous adult stem and regenerative cells are thought to promote healing of scarred or injured tissue. While we are learning more about the exact mechanisms every day, it is believed that this heterogeneous population of cells influences the local environment via cell-to-cell signaling, immune modulation, and differentiation into other cell types. The use of ADRCs in the treatment of many different medical conditions (including cardiovascular disease, soft tissue defects, wound healing, and many more) is being evaluated in around the world, with promising results.

4. What kind of policy changes do you expect from the Central government in order to strengthen Stem Cell research and Stem Cell therapy in India?

The Central government has already started the process of putting in the regulatory infrastructure in place.  It will be important for the Center’s guidelines, which were published almost four years ago,  to be updated to reflect the current situation in the Stem Cell arena, and for these updated guidelines to be converted to law.  This will provide at least some of the clarity needed by the healthcare and research community. 

5. Are there any challenges specifically faced by Hospitals And medical professional/physicians in adopting and providing Stem Cell Therapies? How can they really counter such trouble areas?

Access to safe, clinical-grade cells is the key problem. The first challenge is in Harvesting the source tissue which contains the cells. A bone marrow tap for example, is widely described by patients as painful procedure, and carries an increased risk of infection during recovery process. Increasingly, physicians are countering this challenge looking to alternative source tissues.  Adipose (fat) tissue for example, is widely available, especially considering  liposuction is the leading cosmetic surgery procedure in India, and is provides Stem Cells in much greater quantities than bone marrow. The next challenge lies in the processing of the tissue to isolate the regenerative cells. Typically, physicians need to depend on an laboratory, either their own or outsourced, to process the tissue. Setting up a such a lab, which complies to the strict requirements needed to ensure the safety of the output, is an expensive proposition, both in terms in facilities and staff. In addition, it could take weeks for the lab to expand the cells to get the quantity needed for an effective dose. More and more, physicians are turning to point-of-care solutions such the Celution ™ system, which can deliver an effective dose in about an hour, in a closed, sterile system at the patient’s bedside.  This concept of “real-time” Cell Therapy will be a major paradigm shift in healthcare delivery moving forward, as it will drive down the cost of access to cells for the physicians.