Who is not a good candidate for stem cell therapy?

When may non-surgical care be the wrong fit?

A badly worn joint that aches at rest may need a surgery talk first. Infection, bleeding trouble, or current cancer care can change what's safe. Don't leave those facts until the day of care. Your usual doctor needs a place in the decision.

Be wary when anyone promises a rebuilt joint or says surgery won't ever matter. Slow down if the sales talk moves faster than the exam. I'd ask, "What did you find that makes this fit me?" The answer needs to name the finding in your joint.

What happens before QC Kinetix offers a choice?

Expect questions about the ache and how it limits your day. A doctor examines the joint and looks at useful X-rays. Bring a list of medicines, especially those that affect bleeding. Ask whether simpler care still belongs first.

After that exam, QC Kinetix may offer regenerative treatments, meaning non-surgical care in its clinics from medical providers, the trained staff who checked the sore area. PRP, or platelet-rich plasma, is prepared by concentrating platelets from your own blood. Concentrated PRP may be among the choices discussed. You don't have to decide during that visit.

Which warning signs need care today?

Fever with a hot, swollen joint may mean infection. A sudden loss of weight-bearing after a fall also needs quick care. With back soreness, new weakness or numbness can't wait. Loss of bladder or bowel control needs urgent help.

HonorHealth Tempe Medical Center on South Mill Avenue has a full emergency department. Urgent warning signs belong there. A planned clinic visit can't replace emergency care. If bladder or bowel control is lost, get urgent help.

Sources

1. The OARSI non-surgical management guideline evaluated 60 interventions with GRADE methodology and built its recommendations around core treatments - structured exercise, weight management and self-management education - for every patient with knee osteoarthritis, regardless of what else is added.

   Bannuru RR, et al. — OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage, 2019. DOI: 10.1016/j.joca.2019.06.011.

2. Global Burden of Disease data show osteoarthritis age-standardised prevalence rose 9.3 percent between 1990 and 2017 and years lived with disability rose 9.6 percent, with prevalence higher in women and rising with age.

   Safiri S, et al. — Global, regional and national burden of osteoarthritis 1990-2017: a systematic analysis of the Global Burden of Disease Study 2017. Ann Rheum Dis, 2020. DOI: 10.1136/annrheumdis-2019-216515.

3. FDA states in its consumer alert that the only FDA-approved stem cell products in the United States are blood-forming stem cells derived from umbilical cord blood, approved for disorders of the blood-forming system, and that NONE of these products - stem cells, stromal vascular fraction, umbilical cord blood, Wharton's jelly or amniotic fluid - has been approved for the treatment of any orthopedic condition, including osteoarthritis, tendonitis, disc disease, tennis elbow, back pain, hip pain, knee pain, neck pain or shoulder pain.

   US Food and Drug Administration, Center for Biologics Evaluation and Research — Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes. , 2020.

4. 21 CFR 1271.10(a) sets the four criteria a human cell or tissue product must meet to be regulated SOLELY under section 361 of the Public Health Service Act: it must be minimally manipulated; intended for homologous use only, as reflected by labeling and advertising; not combined with another article beyond water, crystalloids or a preserving agent; and either have no systemic effect and not depend on the metabolic activity of living cells, or else be for autologous use, use in a close blood relative, or reproductive use.

   US Code of Federal Regulations, Title 21 — 21 CFR 1271.10 - Are my HCT/P's regulated solely under section 361 of the PHS Act. , 2004.

5. MACI is FDA-licensed (STN BL 125603, Vericel Corporation) and is indicated for the repair of symptomatic, single or multiple FULL-THICKNESS cartilage defects of the knee with or without bone involvement in adults - a focal defect repair performed surgically, not a treatment for osteoarthritis and not an injection.

   US Food and Drug Administration — MACI (autologous cultured chondrocytes on porcine collagen membrane). , 2016.

6. A phase III double-blind placebo-controlled trial in 261 patients with Kellgren-Lawrence grade 3 knee osteoarthritis tested a single injection of autologous culture-expanded adipose-derived mesenchymal stem cells - a product that cannot legally be sold outside a clinical trial in the United States because culture expansion is more than minimal manipulation.

   Kim KI, et al. — Clinical Efficacy and Safety of the Intra-articular Injection of Autologous Adipose-Derived Mesenchymal Stem Cells for Knee Osteoarthritis: A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial. Am J Sports Med, 2023. DOI: 10.1177/03635465231179223.

7. In a 480-patient, four-arm, multicenter randomized phase 2/3 trial, none of three orthobiologic cell injections - autologous bone marrow aspirate concentrate, autologous adipose stromal vascular fraction, or allogeneic umbilical cord tissue-derived mesenchymal stromal cells - was superior to any other, or to a corticosteroid injection control, on pain at 12 months.

   Mautner K, et al. — Cell-based versus corticosteroid injections for knee pain in osteoarthritis: a randomized phase 3 trial. Nat Med, 2023. DOI: 10.1038/s41591-023-02632-w.