Among the many exciting therapeutic advances is the use of stem cell (SC) therapies. This involves the use of SC that are implanted into a patient with a disease to help repair or restore the dysfunctional organ.
SCl science is not restricted to treatment of disease. In fact, SC are being used to study disease models, develop new medicines, and study drug side effects.
This revolution is coming at a good time since the Baby Boomer population is aging, the costs of delivery of health care is rising, and the availability of drugs to handle the diseases associated with aging are inadequate.
The cost of bringing new drugs to market as well as the time frame involved has become almost prohibitive. Factor in the firewall that has been set up between pharmaceutical companies and practitioners, the outlook for biotech and pharmaceutical companies is bleak.
The expense associated with biologic therapies far exceeds the costs of developing "chemical" drugs. And the fact is, there is de facto care rationing already occurring in the developed countries.
SC therapies, on the other hand, do not require reinvention of the wheel. Autologous SC therapies are already available. Quality control is mandated by FDA scrutiny.
The questions are: should other SC options such as embryonic SC be used? The answer here is that while attractive, ethical debates and religious objections remain a huge barrier to their eventual use.
Induced pluripotential SC, SC derived from adult cells, are intriguing but are still in the developmental stage. These cells behave just like embryonic SC but unfortunately still have some "bugs" that need to be ironed out.
How are SC going to be produced? While the autologous model is a satisfactory one for the time being, it would be beneficial to have options that would provide off the shelf access without subjecting the patient to invasive procedures that entail harvesting. Quality control and consistency as well as safety remain concerns. This brings up the difficulty in providing access to clinical trials involving SC. The process of securing grants from federal agencies such as the National Institutes of Health are arduous and cumbersome. While academic centers may have the time and manpower to pursue this avenue, those physicians on the front lines do not.
Another issue has to do with off shore access to SC. Quite frankly, off-shore facilities lack quality control. The appeal of medical tourism has to do with ready access to questionable products and services as well as lower costs.
It is crucial that centers that offer stem cell therapies be involved in scientific investigation with close measurement of standards, adherence to good clinical practices, as well as measurement of improvement.
Our center is actively involved in the evaluation of autologous SC therapy for osteoarthritis. Careful measurement of both subjective as well as objective data is key. Early reports by our center have been published.
For more information please read this:
(Wei N, Beard S, Delauter S, Bitner C, Gillis R, Rau L, Miller C, Clark T. Guided Mesenchymal Stem Cell Layering Technique for Treatment of Osteoarthritis of the Knee. J Applied Res. 2011; 11: 44-48)
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