Accelerated/Expedited Approval of Stem Cells for TBI, Stroke, and Spinal Cord injury

Accelerated/Expedited Approval of Stem Cells for TBI, Stroke, and Spinal Cord injury

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Thomas Hospod started this petition to Food and Drug Administration and

Disabilities from brain (traumatic and stroke) and spinal cord injuries cost United States taxpayers billions of dollars per year (estimates put it upwards of $40 billion annually). For the FDA to accelerate approval of stem cell transplants to cure/improve these conditions, it would probably be a one-time cost of several million dollars to save us billions in the long run. Several clinical trials have already proven the safety and efficacy of stem cell transplants for these conditions. 

Currently, Accelerated Approval is reserved for "New Drugs for Serious or Life-Threatening Illnesses." Quadriplegia, hemiplegia, paraplegia, and related neurological disorders are, in fact, life-threatening. People with disabilities from motor/neurological deficits are much more likely to suffer further life-threatening injuries to the spine, brain, and other parts of the body. Additionally, people with these conditions suffer from psychological conditions such as depression and anxiety, which can lead to further harm.

A direct consequence of the lack of current approval for stem cell transplants is the proliferation of "stem cell clinics" across the country that offer non-FDA-approved treatments, the efficacy and safety of which have not been properly evidenced by the scientific method, which have defrauded and bankrupted desperate patients and even put their lives in danger. These clinics operate through FDA loopholes, and surreptitiously market their treatments as "patient-funded clinical trials" on databases such as clinicaltrials.gov. This comingling of legitimate and illegitimate clinical trials is dangerous and promotes pseudoscience.

The sooner the FDA approves legitimate stem cell procedures for marketing and general use in the United States, the sooner we can protect people with disabilities from dangerous, unproven treatments, as these clinics are using the hype around stem cells to market their "treatments."

Where multiple clinical trials have already yielded results demonstrating the safety and efficacy of these treatments in Phase 1 and 2 studies, the advantages of putting these treatments and procedures on an accelerated or provisional approval track greatly outweigh the potential detriments of hastening the process. Continuing to withhold these treatments from people with disabilties will be more harmful and costly in the long run.

The ethical/moral concerns have been resolved by the fact that stem cells from bone marrow and adipose tissue have proven superior to fetal/embryonic stem cells. Though many law and policy makers may associate "stem cell research" with these concerns, this is no longer the case.

Furthermore, the longer that neuromuscular symptoms persist, the more likely a patient is to suffer permanent muscle and joint deformity, so this is a time-sensitive condition. "Permanent" disability can only be reversed and prevented through stem cell transplants. Current treatments are limited to physical and occupational therapy - which are very costly and have limited efficacy in people living with severe disabilities.

0 have signed. Let’s get to 2,500!
At 2,500 signatures, this petition is more likely to get picked up by local news!