Since the past six decades, stem cells derived from bone marrow have been used in the medical world as a therapy. Bone marrow transplants had first made their appearance when they were used to treat patients with leukemia. But some years later, the involvement of Congress brought in amendments in connection with the employment of federal funds for research linked with embryonic stem cells.
Recently, a medical company, Regenerative Sciences, established the process of treating orthopedic injuries by using stem cells of the patients themselves. However, this company is struggling intensely with the FDA which feels that human cells have to be regulated as applied drugs. This particular legal battle may take the shape as a landmark one and it may have great implications concerning the future as far as regenerative medicine connected with stem cells derived from bone marrow is concerned.
The crux of this debate is a therapy that utilizes stem cells derived from bone marrow in order to heal the damaged joints among patients who suffer orthopedic injuries. This therapy was pioneered by Regenerative Sciences, a company based in Colorado about a decade ago. They started using it on patients around eight years ago and has accumulated clinical testimony and evidence about its effectiveness.
The Food & Drug Administration has questioned the legality of the therapy’s use and alleges that the stem cells used are more than the required minimum quota of manipulated drugs. FDA is arguing that the therapy has to be regulated and should be thrown open as drugs that are subject to approval.
This particular lawsuit involving stem cells derived from bone marrow concerns every individual who feels that their body cannot be regarded as a drug factory that has to be regulated by the FDA.
Source: Stem Cells and the Lawsuit That May Shape Our Medical Future
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