Biologic therapy uses your blood to prepare a joint shot

PRP is prepared from your blood during the visit

The full name is platelet-rich plasma, shortened to PRP. What's done with your blood matters more than the name.

The concentrated kind adds more platelets to the final shot. You shouldn't agree until you know why that amount is being offered.

During the QC Kinetix visit, a medical provider takes a blood sample, runs it through a spinning machine, saves the platelet part, and gives the joint shot right there. That's what the biologic therapy does to your body.

The exam comes before the shot

Show the nurse or doctor exactly where you're sore. Talk about swelling, stiffness, sleep, and when the trouble began.

After the exam, QC Kinetix may provide regenerative treatment options, its name for blood-based shots prepared there. Its medical providers are the licensed staff who check your movement and swelling.

They'll explain the limits as well as the possible benefit. You don't have to decide until you understand both.

Why is PRP not approved by the FDA?

The clinic prepares PRP from your blood during the visit. It isn't a manufactured drug sold in one standard form.

Government clearance may let the blood-spinning machine be sold. It doesn't prove the shot will ease your soreness.

The catch is simple. A machine's sale clearance isn't proof that the finished treatment works for you.

Get the full price before you agree

Ask for the total cost before saying yes. Insurance often doesn't pay for PRP used for a worn joint or sore tendon.

Find out which visits are included. Then ask whether later care brings another charge.

A low first price won't always cover every visit. Get the full answer in writing.

Sources

1. FDA's July 2020 final guidance 'Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use' is the document that decides whether a given orthobiologic can be used without a licence: an HCT/P may be regulated solely under section 361 only if it is minimally manipulated AND intended for homologous use, among other criteria; otherwise it is a drug or biological product requiring an approved licence or an active investigational new drug application.

   U.S. Food and Drug Administration — Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use - Guidance for Industry and Food and Drug Administration Staff. FDA Guidance Document, 2020.

2. FDA states verbatim of stem cell products, stromal vascular fraction (adipose-derived cells), umbilical cord blood, Wharton's jelly, amniotic fluid and exosome products: 'None of these products have been approved for the treatment of any orthopedic condition, such as osteoarthritis, tendonitis, disc disease, tennis elbow, back pain, hip pain, knee pain, neck pain, or shoulder pain.' The only FDA-approved stem cell products in the United States are blood-forming (hematopoietic progenitor) cells derived from umbilical cord blood, approved only for disorders of blood production, and there are currently NO FDA-approved exosome products.

   U.S. Food and Drug Administration — Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes. FDA (Center for Biologics Evaluation and Research), 2020.

3. FDA's patient and consumer notice on regenerative medicine states that it has received reports of BLINDNESS, TUMOUR FORMATION, neurological events, bacterial infections including life-threatening blood infections, unwanted immune reactions, and cells migrating and forming unintended tissue, following the use of unapproved regenerative medicine products - a list that explicitly includes stromal vascular fraction, amniotic fluid, Wharton's jelly, ortho-biologics and exosomes. It also warns that a product's presence on clinicaltrials.gov, or a firm's registration with FDA, does NOT mean the product is legally marketed.

   U.S. Food and Drug Administration — Important Patient and Consumer Information About Regenerative Medicine Therapies. FDA (Center for Biologics Evaluation and Research), 2021.

4. RESTORE, the largest and most rigorously blinded placebo-controlled PRP trial in knee OA (n=288, participant-, injector- and assessor-blinded), gave three weekly injections of a commercial leukocyte-poor PRP or saline. At 12 months the change in knee pain was -2.1 vs -1.8 points (difference -0.4; 95% CI -0.9 to 0.2; P=.17) and the change in medial tibial cartilage volume was -1.4% vs -1.2% (difference -0.2%; P=.81). Twenty-nine of 31 prespecified secondary outcomes showed no between-group difference. The authors concluded the findings do not support the use of PRP for knee OA.

   Bennell KL, et al. — Effect of Intra-articular Platelet-Rich Plasma vs Placebo Injection on Pain and Medial Tibial Cartilage Volume in Patients With Knee Osteoarthritis: The RESTORE Randomized Clinical Trial.. JAMA, 2021. DOI: 10.1001/jama.2021.19415.

5. Medicare's national coverage determination states that CMS covers autologous platelet-rich plasma ONLY for patients with chronic non-healing diabetic, pressure and/or venous wounds, and only inside an approved coverage-with-evidence-development clinical study. Every approved study listed under the NCD is a wound-healing study. There is no Medicare national coverage for PRP in osteoarthritis or tendinopathy, which is why these injections are billed to the patient.

   Centers for Medicare & Medicaid Services — Autologous Platelet-rich Plasma (Coverage with Evidence Development). CMS.gov, 2024.