What to do before you choose a procedure

What to try before a procedure

Give simple care enough time to work. Build exercise slowly around your sore joint. Spread chores across the day and rest between them. That keeps one busy day from causing several sore days. A cane or brace may also help.

Don't keep doing a motion that raises swelling.

Tell the clinician what you tried and for how long. Include anything that helped briefly. Ask about surgery if you can't sleep, climb steps, dress, or shop as before. Waiting isn't always harmless when joint wear is severe.

When to get help today

Fever with joint heat and swelling needs urgent care. Don't wait for a planned clinic visit. Get help when an injury leaves you unable to stand. An obvious deformity needs care too. New weakness or numbness can't wait.

Back pain with bladder or bowel trouble needs care now.

After any procedure, watch for spreading redness or fever. Calf pain, swelling, or redness can mean a clot. Call for medical help when you're unsure. These signs need different care than long-term soreness.

What to bring and what to ask

Bring a written list of medicines and any X-ray you've had. Say which movements hurt. Name what you can't do now. Ask about likely relief, risks, price, and follow-up. Make sure the quote covers every planned visit.

You can accept an honest “we don't know.”

QC Kinetix's medical providers, the clinicians who examine your joint, offer non-surgical regenerative treatments using blood or tissue taken from you. Find out how the clinic responds if you don't improve. You'll need that answer before paying.

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. 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.

3. FDA's final guidance for industry, issued July 2020 by CBER and CDRH under docket FDA-2017-D-6146, sets out how the agency applies the minimal manipulation and homologous use criteria that determine whether a cell or tissue product is a 361 HCT/P or an unapproved 351 biological product requiring a license.

   US Food and Drug Administration, CBER and CDRH — 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. , 2020.

4. On 27 September 2024 the Ninth Circuit held in United States v. California Stem Cell Treatment Center that stromal vascular fraction produced by enzymatically digesting a patient's own fat IS a drug under the Federal Food, Drug, and Cosmetic Act, and that the same surgical procedure exception does not apply because the removed fat and the implanted SVF are not the same thing. The district court's ruling for the clinics was reversed.

   United States Court of Appeals for the Ninth Circuit — United States v. California Stem Cell Treatment Center, Inc., No. 22-56014 (9th Cir. Sept. 27, 2024). , 2024.

5. A CDC Notes from the Field report in MMWR documented infections in US patients during 2018 after receipt of bacterially contaminated umbilical cord blood-derived products used for indications other than blood or immune reconstitution.

   Perkins KM, et al. — Notes from the Field: Infections After Receipt of Bacterially Contaminated Umbilical Cord Blood-Derived Stem Cell Products for Other Than Hematopoietic or Immunologic Reconstitution - United States, 2018. MMWR Morb Mortal Wkly Rep, 2018. DOI: 10.15585/mmwr.mm6750a5.

6. A laboratory study of three commercially available amniotic fluid products marketed for orthopedic use found no viable mesenchymal stem cells in any of them when compared against unprocessed amniotic fluid and bone marrow-derived MSC samples - products sold as 'amniotic stem cell therapy' contained no living stem cells.

   Panero AJ, et al. — Are Amniotic Fluid Products Stem Cell Therapies? A Study of Amniotic Fluid Preparations for Mesenchymal Stem Cells With Bone Marrow Comparison. Am J Sports Med, 2019. DOI: 10.1177/0363546519829034.

7. A 2019 survey identified 40 US companies operating 76 clinics marketing 'cell therapy' for eye conditions, most using autologous adipose-derived cells, concentrated in California, Florida and Illinois - a map of how far the marketplace reaches beyond orthopedics.

   Nirwan RS, et al. — Assessing "Cell Therapy" Clinics Offering Treatments of Ocular Conditions using Direct-to-Consumer Marketing Websites in the United States. Ophthalmology, 2019. DOI: 10.1016/j.ophtha.2019.03.019.

8. 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.