Biologic therapy Scottsdale: blood-based shots for sore joints

Gentle movement can loosen a stiff joint

Move only as far as feels easy. You don't have to push through sharp soreness.

Take a short walk for a stiff knee or hip. For a shoulder, slowly lift and lower your arm.

Stop before the joint gets more sore. You can try a little more after a calm day.

Wear and repeated work often explain the soreness

Wear can cause stiffness after sitting. A long day may leave the same joint sore or swollen.

A tendon can get sore after repeated lifting or reaching. That doesn't always mean it has torn.

Notice the time and task when soreness begins. One sore spot can't tell you the whole cause.

QC Kinetix starts with an exam

An exam makes sense if the soreness comes back often. Don't wait if it's changing your walk or sleep.

At QC Kinetix, biologic therapies mean shots made there from your blood; a medical provider draws it, spins it, and puts one part into your joint during the visit. The clinic calls these blood-based shots regenerative treatments.

A medical provider is the licensed clinic worker who examines you. You'll hear whether a non-surgical choice fits and what it may cost.

A hot, swollen joint with fever needs quick care

Don't wait for a regular joint visit if the joint is hot and swollen. Fever or feeling ill makes the need more urgent.

If you can't stand or use the arm after getting hurt, get help right away. New weakness or numbness also needs prompt care.

Those problems come before any talk about blood-based shots. A doctor has to check them first.

Sources

1. 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.

2. 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.

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. 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.

5. 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.