Our regenerative treatments, including platelet-rich plasma (PRP) and bone marrow concentrate (BMAC), use autologous biologic materials processed and administered on the same day under physician supervision. These procedures are performed in accordance with applicable FDA guidance for human cells, tissues, and cellular and tissue-based products (HCT/Ps), including Section 361 regulatory considerations.
The U.S. Food and Drug Administration (FDA) regulates HCT/Ps to help ensure patient safety and product quality. These procedures typically fall under the same-day autologous use framework, in which cells are minimally manipulated and used within their original biological function.
While these therapies are widely used in clinical practice, they are not individually FDA-approved for the treatment of musculoskeletal or spine conditions. Treatment decisions are based on clinical evaluation, current medical evidence, and physician expertise.
Any off-label use of medications or biologic preparations is fully disclosed and discussed with each patient prior to treatment.
The information provided on this website is for educational purposes only and is not intended as medical advice.
Clinical Research & Evidence
Peer-reviewed studies have evaluated regenerative therapies such as platelet-rich plasma (PRP) and bone marrow aspirate concentrate (BMAC) in selected musculoskeletal and spine conditions. Outcomes vary based on diagnosis, severity, patient selection, and treatment protocols. The studies below are provided for educational purposes only and should not be interpreted as a guarantee of results or as individualized medical advice.
- Platelet-Rich Plasma Versus Hyaluronic Acid for Knee Osteoarthritis: A Systematic Review and Meta-analysis of Randomized Controlled Trials
PubMed PMID: 32302218 - Patients With Knee Osteoarthritis Who Receive Platelet-Rich Plasma or Bone Marrow Aspirate Concentrate Injections Have Better Outcomes Than Patients Who Receive Hyaluronic Acid: Systematic Review and Meta-analysis
PubMed PMID: 36913992 - Bone Marrow Aspirate Concentrate for the Treatment of Osteoarthritis of the Knee: A Systematic Review of Outcomes
PubMed PMID: 34236913 - The Effect of Intradiscal Platelet-Rich Plasma Injection for Management of Discogenic Lower Back Pain: A Meta-Analysis
PubMed PMID: 33642874 - Comprehensive Evidence-Based Guidelines for Regenerative Therapies in the Management of Chronic Low Back Pain: 2025 Update from the American Society of Interventional Pain Physicians (ASIPP)
PubMed PMID: 41481869 - Platelet-Rich Plasma Has Better Results for Long-term Functional Improvement and Pain Relief for Lateral Epicondylitis: A Systematic Review and Meta-analysis
PubMed PMID: 38357713 - Platelet rich plasma therapy versus other modalities for treatment of plantar fasciitis: A systematic review and meta-analysis
PubMed PMID: 38395675 - Platelet-rich plasma in non-operative management of mild to moderate carpal tunnel syndrome – A systematic review & meta-analysis of short-term outcomes
PubMed PMID: 35068775
These references are intended to provide general background on the evolving clinical literature. Treatment recommendations should always be based on physician evaluation, diagnosis, current evidence, and patient-specific considerations.
For more information, call our office at (718) 488-0188
Page Updated on Apr 27, 2026 by Stem Cell Therapy