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How Effective Is Platelet Rich Plasma Therapy?
Question: There is a procedure being offered where they take your blood and develop plazma that they inject into your feet. The group claims that it is FDA approved. Are you aware of this and has it been successful? I think I would need a Neurologist to advise me?
Brief Answer:
Consultation
Detailed Answer:
Hi XXXX, thanks for asking from HCM.
I can understand your concern. This test is known as Platelet rich plasma therapy, that is what I am getting from your description. If I am correct then I am mentioning some information which would be helpful to you.
Plasma therapy does not follow traditional pathway of FDA's Center for Biologics Evaluation and Research (CBER) approval.CBER is responsible for regulating human cells, tissues, and cellular and tissue-based products. The regulatory process for these products is described in the FDA's 21 CFR 1271 of the Code of Regulations. Under these regulations, plasma therapy is exempt and therefore does not follow the FDA's traditional regulatory pathway that includes animal studies and clinical trials. The 510(k) application is the pathway used to bring PRP preparation systems to the market.
So platelet rich plasma therapy is FDA approved but without animal testing.
Various medical studies have shown good results in providing relief in pain in cases of tendon/muscular injury and osteoarthritis. It is commonly used for sports injury.
Hope it will help you. If still any doubt, do let me know. I would be happy to help you.
Thanks. Take care
Consultation
Detailed Answer:
Hi XXXX, thanks for asking from HCM.
I can understand your concern. This test is known as Platelet rich plasma therapy, that is what I am getting from your description. If I am correct then I am mentioning some information which would be helpful to you.
Plasma therapy does not follow traditional pathway of FDA's Center for Biologics Evaluation and Research (CBER) approval.CBER is responsible for regulating human cells, tissues, and cellular and tissue-based products. The regulatory process for these products is described in the FDA's 21 CFR 1271 of the Code of Regulations. Under these regulations, plasma therapy is exempt and therefore does not follow the FDA's traditional regulatory pathway that includes animal studies and clinical trials. The 510(k) application is the pathway used to bring PRP preparation systems to the market.
So platelet rich plasma therapy is FDA approved but without animal testing.
Various medical studies have shown good results in providing relief in pain in cases of tendon/muscular injury and osteoarthritis. It is commonly used for sports injury.
Hope it will help you. If still any doubt, do let me know. I would be happy to help you.
Thanks. Take care
Above answer was peer-reviewed by :
Dr. Naveen Kumar
Answered by
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