StemSpine® is a patented stem cell based treatment for degenerative disc disease (DDD) and associated back pain. It is provided by Creative Medical Technology Holdings, Inc., a commercial stage biotechnology company committed to improving patient lives in the areas of urology, neurology, and orthopedics utilizing stem cells. StemSpine® is the direct result of research and collaboration between some of the preeminent scientists and physicians in the world who specialize in orthopedics/neurology and stem cell therapy.
StemSpine® has the pedigree of being developed by leaders in the field of stem cell treatments and offers a drug free alternative to patients suffering with DDD and back pain. It is a stem cell based treatment for DDD which is not a drug and also falls within the FDA’s guidelines for stem cell treatments and specifically exception 21 CFR 1271.15(b).
This FDA guidance allows for removing and implanting “human cells, tissues, and cellular or tissue-based products” (HCT/Ps) into the same individual from whom they were removed (autologous use) and implanting the HCT/Ps within the same surgical procedure, However to be compliant, the HCT/Ps must remain in their original form, which means that they are only rinsed, cleaned, sized, or shaped in the procedure.
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