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Is PRP FDA approved?

PRP Prolotherapy- An Overview

Platelet-Rich Plasma (PRP) is the blood plasma loaded with platelets. It has been quite some time since PRP has been in use as a treatment option for musculoskeletal disorders, chronic conditions, and sports injuries. The reason behind separating and using only the platelets from the entire blood lies in the fact that platelets contain many growth factors which promote healing.

A PRP device is used for increasing the concentration of platelets in the blood plasma. Using the device, PRP is prepared by two methods: PRP method and buffy coat method. Both methods take in the patient's whole blood anti-coagulated with citrate dextrose followed by centrifugation. After anti-coagulating, the blood centrifugation is done to raise the concentration of extracted plasma and to separate the PRP from platelet-poor plasma (PPP). The U.S. Food and Drug Administration (FDA) approved these methods of PRP preparation in 2009.

Why PRP Therapy?

PRP is used in various medical treatments, such as nerve injury, orthopaedic injuries, plastic surgeries, and cosmetic surgery. The following are the applications of PRP, in brief:

Musculoskeletal Injuries- PRP can manage various orthopedic injuries and is being extensively used in sports medicine. Application of PRP on the injured areas decreases the healing time, which further decreases the chances of surgery. Hence, PRP is an alternative to surgery for the musculoskeletal injury.

The following are a few more conditions in which PRP gives desired results:

• Pain in lumbar spine disc
• Injury to the rotator cuff
• Medial and lateral epicondylitis
• Sprain in knee
• Sprain in ankle
• Sprain or strain in the hamstring muscles
• Osteoarthritis of the hip or knee
• Carpal tunnel syndrome
• Dysfunction or pain in the sacroiliac joint
• Arthritis of the shoulder
• Arthritis of the hip
• Arthritis of the knee
• Arthritis of the ankle

Plastic Surgery- PRP is a boon for people who wish to look better following plastic surgery or grafting. It promotes an early wound healing after you have received a graft. A systemic review was done taking data from the PubMed and Cochrane Library to study the benefit of PRP in wound healing following grafts. The terms platelet-rich and plastic surgery were searched in the data sources. A total of 15 randomized controlled trials and 25 case-control studies were found which showed that PRP aids early wound healing, increasing the survival rate following grafts.

Cosmetic Benefits- Another important use of PRP in current times are cosmetic. It has been proved that PRP injections are very successful in treating wrinkles of the face, hands, and neck. Apart from the face, PRP is also used in hair transplantation. PRP not only increased the healing process following PRP application but also improved the hair growth seen after transplantation.

Nerve Injuries- The most recent use of PRP is seen in dealing with nerve injuries. Various studies have been conducted to study the effect of PRP in peripheral neuropathies. The first ever treatment of nerve injury using PRP was done in 2012, proving it to be a pretty new application of PRP.

PRP was given in the form of injection under ultrasound guidance. These injections resulted in promoting nerve regeneration. Sanchex et al conducted a study on a man suffering from peroneal nerve palsy along with foot drop. The patient had received 11 months of conservative treatment with no positive result. He was then given PRP injections under ultrasound guidance, with regular follow-ups. After 21 months, EMG showed a marked improvement in the muscular activity. The patient was able to run without orthosis. This proves the effectiveness of PRP in neural injuries.

Is PRP Therapy FDA Approved?

It is now very well understood that PRP is not only useful for treatment but also helps increase the platelet concentration in the blood plasma. Since there are significant health claims related to the use of PRP therapy, an FDA approval is quite necessary for both PRP and PRP devices. The role of the FDA is to protect the health of people by monitoring the drugs, biologics, medical devices, food, cosmetics and radiation releasing devices. As stated, PRP is a biologic (plasma with raised number of platelets) substance.

In general, the FDA approves a new drug, biologic or a device, for its safety and efficacy before they are introduced into the market. The approval involves obtaining clinical data from the Investigational New Drug (IND) application. The drug is then released into the market after getting an approval from the New Drug Application (NDA). The biologics may be approved by the Biologics License Applications (BLAs), or by the Premarket Notification (510(k)). Medical devices, depending on the risk classification, are approved either by the Premarket Approval (PMA) or 510(k). NDA, BLAs, and PMA need a clinical review data from the IDE, whereas, 510(k) does not need any clinical review. This is an advantage of 510(k) application. Another advantage of 510(k) is that its main focus is on the device safety and efficacy.

The use of 510(k) is for low-risk devices that are considered to be the same as the basic devices. Any device approved by the 510(k) is given a 510(k) 'clearance.' It is essential to give clearance rather than approval because clearance indicates identical to the basic device. 510(k) is also important to market the device.

510(k) clearance for the PRP device is of use as it decreases the risks and enhances the performance of PRP by boosting the process of centrifugation. Nearly all the PRP devices in the market have FDA clearance. Also, PRP does not need any clinical review. However, for PRP that is meant to be mixed with bone grafts, the device should have 510(k). The PRP produced cannot be applied directly to the patient without adding it in bone graft material. Devices that are proposed to be used in any operation or surgery should have 510(k) clearance.

Clinical PRP, used by the health care providers, also needs an FDA approval. PRP, if used in the outpatient setting without an FDA approval, is termed as off-label. If a PRP device is introduced into the market with 510(k) clearance, and the clearance is similar to the PRP device that is used in operation during bone grafting, then the treatment given in outpatient setting is termed as off-label. This suggests that either BLA or PMA approval is needed for PRP to be used in an outpatient setting. For BLA or PMA approval a clinical review needs to be done making it a time-consuming and costly procedure.

Blood products, such as PRP, fall under FDAs Center for Biologics Evaluation and Research (CBER). CBER monitors the human cells, tissues, and cellular and tissue-based products. CBER has no control over the medicine practice, hence health care providers are free to use PRP off-label until all the requirements are met. The CEBR says that the medicine can be used off-label if the provider has adequate knowledge and has kept records of about its use and effects. They don't need to submit any clinical trial under IND or IDE for review by the Institutional Review Board (IRB). On the other hand, IRB approval following an IND or IRE clinical trial is needed if PRP is used as a diagnostic tool.

The FDA has set up rules for the use of PRP for implantation, infusion or transplantation, and similar procedures. The FDA has divided human cells, tissues, cellular and tissue-based products (HCT/Ps) into two groups: high risk and low-risk products. The low-risk products are the ones with least manipulation and are not combined with any other product, except for simple electrolyte and preservation solutions, which are either autologous or have a non-systemic effects. HCT/Ps obeying these rules is legalized under section 361 of the Public Health Service Act and is called 361 products. All other HCT/Ps considered high risks are legalized under section 351. They need animal and clinical data through the FDA's traditional PMA route.

In 2005, the FDA stated that any procedure that needs human cells to be transplanted for a clinical trial is subject to error. Therefore, they should be subjected to least manipulation and need the approval to prevent any disease transmission. Over manipulating the human cells need approval because they start acting as drugs. This has led to an increased use of 510(k) cleared PRP as "more than minimally activated product." Till date, FDA is trying to control activated PRP and there is still a discussion over the role of FDA rather than its focus to control PRP.

The FDA has not given an approval of using PRP in sports injury. Regardless of this disapproval, PRP is being used in the management of sports injuries as it leads to an early healing.

As discussed, PRP is not an artificial treatment, it is produced naturally. Many studies have been conducted which show the efficiency of PRP injections in tendonitis. Currently, the FDA approval is awaiting, however, such injections are considered exception in use, as they are prepared from patient's own blood. FDA has also approved the use of PRP as allograft or autograft in orthopedic surgery and in non-healing diabetic ulcers.

In conclusion, we can say that the FDA has no objection in the application of PRP in both medical and surgical management. However, health care providers need to stay updated with the recent changes in PRP approval by the FDA.

References:

Beitzel K, Allen D, Apostolakos J, et al. US definitions, current use, and FDA stance on the use of platelet-rich plasma in sports medicine. J Knee Surg. 2015;28(1): 29-34. PMID: 25268794 www.ncbi.nlm.nih.gov/pubmed/25268794

Dhurat R, Sukesh MS. Principles and methods of preparation of platelet-rich plasma: A review and author's perspective. J Cutan Aesthet Surg. 2014;7(4):189-197. www.ncbi.nlm.nih.gov/pmc/articles/PMC4338460/. Accessed October 13, 2016.

Garbis N, Romeo, AA, Thiel GV, et al. Clinical indications and techniques for the use of platelet-rich plasma in the shoulder. Operative Techniques in Sports Medicine. 2011;9(3): 65-69.

Malahias M, Chytas D, Babis GC, Nikolaou VS. Platelet-rich plasma guided injections: clinical application in peripheral neuropathies. Front Surg. 2014. www.ncbi.nlm.nih.gov/pmc/articles/PMC4286980/. Accessed October 13, 2016

Nerve regeneration- the future doesn't involve surgery. Regenexx. www.regenexx.com/nerve-regeneration/. Accessed October 13, 2016

Platelet-rich plasma in hair transplantation. Innternational Society of Hair Restoration Surgery. www.ishrs.org/article/platelet-rich-plasma-hair-transplantation. Accessed October 13, 2016

Sommeling CE, Heyneman A, Hoeksema H, Verbelen J, Stillaert FB, Monstrey S. the use f platelet-rich plasma in plastic surgery: A systemic review. An International Journal of Surgical Reconstruction. 2013;66(3):301-311. www.jprasurg.com/article/S1748-6815(12)00640-7/abstract