What Is PRP Treatment: Evidence, Uses, and Safety

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Understanding PRP Treatment: Scientific Insights, Preparation Techniques, and Regulatory Landscape

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Platelet-rich plasma (PRP) is an autologous biologic derived from a patient’s blood components, processed to concentrate platelets suspended in plasma. As a source of growth factors, cytokines, and bioactive proteins, PRP has been proposed for use in a wide range of tissue repair and modulation therapies [1]. While certain preparation systems are cleared by the U.S. Food and Drug Administration (FDA), the therapeutic use of PRP remains largely off-label in most clinical specialties [2].

This article outlines the current understanding of PRP preparation, regulatory status, clinical evidence, including approved and investigational uses, and practical considerations relevant to licensed healthcare professionals. It is intended as a non-promotional, scientific summary for healthcare providers evaluating or utilizing PRP in their clinical practice.

Platelet-Rich Plasma (PRP) Therapy: FDA-Cleared Uses

FDA clearance for PRP systems applies strictly to the preparation of autologous platelet-rich plasma for use in defined surgical contexts. These systems are cleared under the 510(k) pathway for use in bone graft handling [2]. See cleared 510(k) submissions with supporting documents.

It is important to note that these clearances pertain to the device's mechanical function—specifically, the separation and concentration of platelets from whole blood—not to clinical claims of effectiveness for any particular disease or therapeutic outcome. As such, the use of PRP for musculoskeletal, dermatologic, or aesthetic conditions remains off-label [3].

Device labeling generally includes precautions and contraindications related to sterile technique, anticoagulation status, infection risk, and platelet dysfunction [3]. Off-label use is permitted under a physician’s discretion but must be guided by sound clinical judgment, informed consent, and compliance with applicable ethical and regulatory standards [3].

For device-specific information, doctors and clinicians should consult the FDA’s 510(k) database and the manufacturer's Instructions for Use (IFU).

How Platelet-Rich Plasma Injections Work

PRP’s proposed mechanisms of action are primarily mediated by the delivery of concentrated platelets to injured or diseased tissue [1][4]. Upon activation, these platelets release growth factors such as platelet-derived growth factor (PDGF), vascular endothelial growth factor (VEGF), and transforming growth factor-beta (TGF-β), which interact with local cells to promote tissue remodeling, angiogenesis, and anti-inflammatory signaling [4].

Clinical preparation involves venous blood collection, centrifugation using a PRP system, and extraction of the platelet-rich layer [5][6]. Leukocyte concentration and platelet yields may vary depending on the system and protocol [5]. Most applications utilize autologous PRP; although preclinical research into allogeneic PRP is underway, its use remains rare and outside the scope of current clinical practice [6].

The rationale for PRP therapy extends across tissue types—from intra-articular cartilage to dermal structures—yet the biologic plausibility must be distinguished from evidence-based clinical outcomes [2][7].

Clinical Evidence on Unapproved Uses of PRP Injections

Note: The following uses of PRP treatment have not been approved by the FDA. Safety and effectiveness have not been established.

A. Musculoskeletal Applications of Platelet-Rich Plasma Injections

PRP has been explored as a treatment for various musculoskeletal conditions, including soft tissue injuries such as tendinopathy, ligament injuries, and knee osteoarthritis [2][8][16]. PRP is used primarily for soft tissue injuries, such as tendon and ligament injuries. Studies have shown mixed results, with some demonstrating improved pain and function [16], while others indicate no significant benefit over placebo [1][17]. The heterogeneity in study designs and PRP preparation methods contributes to these inconsistent findings.

B. PRP Injections in Dermatology and Aesthetics

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Platelet-rich plasma therapy has been investigated for treating hair loss conditions like androgenetic alopecia [9] and for skin enhancement purposes [10]. Clinical trials have reported increased hair density and improved skin texture following PRP treatment [11]. However, the lack of standardized protocols and long-term data necessitates further research to establish efficacy and safety [10][11]. These outcomes have not been confirmed in large, well-controlled trials, and PRP use for these indications remains investigational.

C. Surgical and Postoperative Settings

PRP has been utilized as an adjunct in surgical procedures, such as rotator cuff repair, spinal fusion, and anterior cruciate ligament (ACL) reconstruction. Some studies report benefits like reduced retear rates and early symptom relief [12][13], while others show minimal or no added value [14]. Variability in PRP formulations and study designs contributes to these inconsistent results. More high-quality randomized controlled trials are needed to confirm its clinical utility.

Potential Risks and Limitations of PRP Therapy

Despite being derived from the patient’s own blood, PRP injections carry minimal risk and are not without other potential complications. Common complications include local discomfort, transient swelling, bruising, and inflammation at the injection site [15]. Patients may start to experience symptom relief a few days after receiving PRP treatment. Infection risk, though rare, exists, particularly when sterile technique is compromised [15].

Device-specific risks are influenced by platelet concentration, leukocyte inclusion, and volume injected [1][15]. The variability among PRP systems means that no universal preparation or efficacy standard exists, further complicating safety assessments.

Contraindications include platelet disorders, local infections, active malignancy at the treatment site, and severe anemia [15]. Patient screening and adherence to device protocols are essential for mitigating potential complications.

Interpreting the Evidence on Platelet-Rich Plasma (PRP) Treatment

Platelet-rich plasma (PRP) therapy is used across multiple medical fields, but clinical evidence remains inconsistent due to variability in preparation methods, dosing, and patient selection. Some randomized controlled trials show significant improvements [16][18], while others report no benefit over placebo [17][19]. The effects of a PRP injection may last from six months to a year or longer, depending on the condition.

A meta-analysis found PRP effective in reducing pain in tendinopathy [16], while another review noted limited evidence for PRP in knee osteoarthritis due to small sample sizes and methodological flaws [17]. Other studies show PRP may outperform hyaluronic acid for osteoarthritis symptoms [18], yet inconsistent protocols limit broad conclusions [19].

Given these mixed results, clinicians should evaluate the evidence carefully and ensure ethical, patient-centered use through informed decision-making.

Contributor Disclosures, References, and Device Labeling Access

This content was developed independently and is not sponsored by any PRP system manufacturer or distributor, relying solely on the principles of using the patient's own body. No financial relationships, commercial interests, or conflicts of interest influenced the content.

For device-specific details, providers should consult the FDA 510(k) database and manufacturers’ Instructions for Use. FDA-cleared PRP systems outline intended use, precautions, and contraindications. Off-label use requires the same rigor and ethical standards as investigational treatments.

The referenced literature includes peer-reviewed clinical trials, systematic reviews, and regulatory documents. Most studies are limited by design heterogeneity, non-standardized PRP formulations, and short-term outcomes. Many unapproved uses rely on small or uncontrolled cohorts, highlighting the need for cautious interpretation and further research to support clinical consensus.

Treatment Option Comparison

Comparative Overview: PRP vs. Other Injection Therapies

Treatment Modality	Indications	Mechanism	Typical Duration
PRP Injections	Tendinopathies, OA, Hair Loss [8][11][16]	Autologous growth factors  [8][11][16]	6–12 months  [8][11][16]
Corticosteroids	Acute inflammation [20]	Immunosuppression [20]	1–3 months [20]
Hyaluronic Acid	Knee OA [21]	Joint lubrication and viscoelasticity [21]	3–6 months [21]

This table highlights the varying mechanisms and evidence levels across injectable options, aiding in clinical decision-making. PRP use for most indications listed remains off-label. Effectiveness has not been established.

Timeline of Major Clinical Trials and Publication Dates

The following timeline includes investigational milestones; clinical use of PRP for most listed applications remains unapproved by the FDA.

Time	Field	Application/Milestone
Pre-1980s	Hematology [22]	Used as a transfusion product to manage thrombocytopenia [23]
Late 1980s	Regenerative Medicine	A study showed that platelet-derived bioactive molecules promote tissue healing [24]
1990s	Maxillofacial Surgery	First surgical use of PRP to enhance wound healing and graft integration [25]
Early 2000s	Orthopedics, Plastic Surgery	Expanded into tissue repair and aesthetic procedures [26]
2000s–Present	Multidisciplinary	Widely adopted in orthopedics, dentistry, dermatology, plastic surgery, and sports medicine [1][4][13]

Conclusion

PRP is a promising biologic therapy with applications in multiple medical fields. While some systems are FDA-cleared, many uses, especially in orthopedics, dermatology, and aesthetics, are off-label and lack strong clinical validation. Clinicians should use PRP cautiously, follow ethical standards, and inform patients about its experimental nature. Ongoing research and standardized protocols are essential to define its full therapeutic role.

References

1. Patel, H. et al. (2023) 'A comprehensive review on Platelet-Rich plasma activation: a key player in accelerating skin wound healing,' Cureus [Preprint]. [DOI] [PubMed] [PMC free article]

2. Beitzel, K. et al. (2014) 'US Definitions, Current Use, and FDA Stance on Use of Platelet-Rich Plasma in Sports Medicine,' The Journal of Knee Surgery, 28(01), pp. 029–034. [DOI] [PubMed]

3. Arolkar, S. (2015) 'A Word of Caution,' Indian Journal of Plastic Surgery, 48(02), pp. 215–216. [DOI] [PubMed] [PMC free article]

4. Sheean, A.J., Anz, A.W. and Bradley, J.P. (2021) 'Platelet-Rich Plasma: Fundamentals and Clinical Applications,' Arthroscopy the Journal of Arthroscopic and Related Surgery, 37(9), pp. 2732–2734. [DOI] [PubMed]

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8. Lee, K.S. et al. (2011) 'Musculoskeletal Applications of Platelet-Rich Plasma: Fad or Future?,' American Journal of Roentgenology, 196(3), pp. 628–636. [DOI] [PubMed]

9. Stevens, J. and Khetarpal, S. (2018) 'Platelet-rich Plasma for Androgenetic Alopecia: A Review of the Literature and Proposed Treatment Protocol,' International Journal of Women’s Dermatology, 5(1), pp. 46–51. [DOI] [PubMed] [PMC free article]

10. Asubiaro, J. and Avajah, F. (2024) 'Platelet-Rich Plasma in Aesthetic Dermatology: Current Evidence and Future Directions,' Cureus [Preprint]. [DOI] [PubMed]

11. Gentile, P. et al. (2015) 'The Effect of Platelet-Rich Plasma in Hair Regrowth: A Randomized Placebo-Controlled Trial,' Stem Cells Translational Medicine, 4(11), pp. 1317–1323. [DOI] [PubMed] [PMC free article]

12. Rossi, L.A. et al. (2024) 'Leukocyte-Poor Platelet-Rich Plasma as an Adjuvant to Arthroscopic Rotator Cuff Repair Reduces the Retear Rate but Does Not Improve Functional Outcomes: A Double-Blind Randomized Controlled Trial,' The American Journal of Sports Medicine, 52(6), pp. 1403–1410. [DOI] [PubMed]

13. Zhu, T. et al. (2022) 'Effects of Platelet-Rich Plasma on Clinical Outcomes After Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis,' Orthopaedic Journal of Sports Medicine, 10(1). [DOI] [PubMed]

14. Cai, Y.-F. et al. (2020) 'The Effect of Platelet-rich Plasma on the Fusion Rate and Clinical Outcome of Spinal Fusion Surgery: A Systematic Review and Meta-analysis,' PLoS ONE, 15(12), p. e0243204. [DOI] [PubMed] [PMC free article]

15. Eymard, F. et al. (2025) 'Indications and Contraindications to Platelet‐rich Plasma Injections in Musculoskeletal Diseases in Case of Infectious, Oncological and Haematological Comorbidities: A 2025 Formal Consensus From the GRIIP (International Research Group on Platelet Injections),' Knee Surgery Sports Traumatology Arthroscopy [Preprint]. [DOI] [PubMed]

16. Fitzpatrick, J., Bulsara, M. and Zheng, M.H. (2016) 'The Effectiveness of Platelet-Rich Plasma in the Treatment of Tendinopathy: A Meta-analysis of Randomized Controlled Clinical Trials,' The American Journal of Sports Medicine, 45(1), pp. 226–233. [DOI] [PubMed]

17. Khoshbin, A. et al. (2013) 'The Efficacy of Platelet-Rich Plasma in the Treatment of Symptomatic Knee Osteoarthritis: A Systematic Review With Quantitative Synthesis,' Arthroscopy the Journal of Arthroscopic and Related Surgery, 29(12), pp. 2037–2048. [DOI] [PubMed]

18. Dai, W.-L. et al. (2016) 'Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Meta-analysis of Randomized Controlled Trials,' Arthroscopy the Journal of Arthroscopic and Related Surgery, 33(3), pp. 659-670.e1. https://doi.org/10.1016/j.arthro.2016.09.024. [DOI] [PubMed]

19. Shen, L. et al. (2017) 'The Temporal Effect of Platelet-rich Plasma on Pain and Physical Function in the Treatment of Knee Osteoarthritis: Systematic Review and Meta-analysis of Randomized Controlled Trials,' Journal of Orthopaedic Surgery and Research, 12(1). [DOI] [PubMed] [PMC free article]

20. Ramamoorthy, S. and Cidlowski, J.A. (2015) 'Corticosteroids,' Rheumatic Disease Clinics of North America, 42(1), pp. 15–31. [DOI] [PubMed] [PMC free article]

21. Bhadra, A.K. et al. (2016) 'Appropriate Use Criteria for Hyaluronic Acid in the Treatment of Knee Osteoarthritis in the United States,' Cartilage, 8(3), pp. 234–254. [DOI] [PubMed] [PMC free article]

22. Andia, I. and Abate, M. (2013) 'Platelet-Rich Plasma: Underlying Biology and Clinical Correlates,' Regenerative Medicine, 8(5), pp. 645–658. [DOI] [PubMed]

23. Alves, R. and Grimalt, R. (2017) 'A Review of Platelet-Rich Plasma: History, Biology, Mechanism of Action, and Classification,' Skin Appendage Disorders, 4(1), pp. 18–24. [DOI] [PubMed] [PMC free article]

24. Knighton, D.R. et al. (1986) 'Classification and Treatment of Chronic Nonhealing Wounds,' Annals of Surgery, 204(3), pp. 322–330. https://doi.org/10.1097/00000658-198609000-00011. [DOI] [PubMed] [PMC free article]

25. Plasma Rich in Growth Factors: Preliminary Results of Use in the Preparation of Future Sites for Implants (1999). https://pubmed.ncbi.nlm.nih.gov/10453668/ (Accessed: May 19, 2025). [PubMed]

26. Montero, E.C., Santos, M.E.F. and Fernández, R.S. (2014) 'Plasma Rico En Plaquetas: Aplicaciones En Dermatología,' Actas Dermo-Sifiliográficas, 106(2), pp. 104–111. [DOI] [PubMed]