Wednesday, December 12, 2012 -Posted by Fadi Bejjani
Best when Served Fresh, Cool and Au Jus
Recently we are beginning to distinguish readily between embryonic stem cells, and cord blood and adult stem cells. The Vatican published a paper last year supporting the later research at the expense of the former of course. Grant funding have been guided accordingly trying to steer away from embryonic although constraints have been lifted lately by our government. The discussion is now more of an FDA discussion. How much can these cells be multiplied and induced to differentiate prior to reinjecting them before the FDA can call them a drug and start applying the same rigid protocols it does for the pharmaceuticals. We all know that these processes are far from error-proof (refer to blog on PharmaEconomics). Although blood is commonly auto transfused, and skin is often taken from one part of the body to graft on another, same as arteries, veins and nerves and no FDA approval is needed for all that.
When it comes to your own stem cells, even if they are not manipulated or very little, the FDA wants to treat them as a drug if you plan to reinject them. They may give a narrow pass to your bone marrow cells being reinjected into your bones, joints and tendons because it has to do with blood, but they will not see the same way adult adipose stem cells AASCs. These are mesenchymal in nature meaning they are from the same lineage as tendons, ligaments, joints, nerves, muscles, etc. Most importantly there are A LOT of them about 500x more than bone marrow far example and they are easy to retrieve via mini-liposuction. A small amount of fat is aspirated, ASCSs are extracted in great numbers and can be used within 30 minutes IV or IA on the patient him/herself "Fresh, Cool and Au Jus"; or more scientifically "autologous". Doctors OUTSIDE the US are using this cheap and simple methodology to treat a large number of conditions: shoulders, knees, macular degeneration, cerebral palsy, multiple sclerosis, autism, paraplegia, you name it.
When I attended last years meeting of the International Society for Cell Therapy (ISCT) in Seattle I witnessed the reason why I think the FDA is taking this approach. Millions of dollars in grants are being distributed to many prestigious university laboratories, only matched by large investments from GE, Unilever and others, are going into this arena, primarily for embryonic, cord and hematopoietic (from blood) stem cells. An inordinate number of workshops was offered on the business and commercialization aspects of this field. Then it dawned on me that the FDA does not want to support any autologous approach (where doctors do it on the spot in their office) nor it should or knows how to do that. They want to put the weight of their bureaucracy, funding and regulations on the side of the allogeneic research, meaning that patient A would be getting processed shrink-wrapped cells from patients XYZ. This indeed is the pharmaceutical model they are most familiar with and they can easily implement, as compared to monitor individual doctors' offices throughout the country. Besides this is where the money multipliers are, just like new drugs on the market. Of course big Pharma wholly support that because they can commercialize it and make money from it. You can already buy about 1 cc of dried up cells in a bottle for about $5,000, like you would a pharmaceutical drug.
So what happened with HEAL THYSELF (see previous blog)?. Using your own stem cells for repairs throughout your body certainly fits this golden principle. AMERICAN CRYOSTEM very energetic and ambitious company, considered by Forbes second in the country for stem cell storage and banking, found a very innovative way to respect the Heal Thyself principal without infringing on FDA policies: They are featuring personalized and customized cosmetics populated by your own AASCs extracted from your own body, that are delivered to your doorstep every month. Cosmetics are indeed a lot less FDA regulated and American Cryostem's ingenious idea skirts all that and delivers these cells back into your body month after month, for a fee of course. Pilot studies in California have already showed skin improvements, i.e. wrinkles and elasticity. The real question remains can this delivery mode bring enough AASCs into the general circulation to effect more systemic conditions. It remains to be seen but FDA STAY AWAY... for now!