Regenerative Medicine · Dr. Andrew Dold · Frisco, TX

Stem Cell Injections: Facts vs. Marketing

Ads for “stem cell” injections promise to regrow cartilage and help you avoid surgery. Here is what the FDA and the research actually say, how to spot red flags, and how Dr. Dold approaches regenerative treatments.

Request an AppointmentCall 469-850-0680BMACPRPAll biologic treatments
Not FDA-approved for jointsThe FDA states that regenerative medicine therapies have not been approved to treat any orthopedic condition.
Your own cells onlyDr. Dold uses only your own blood (PRP) or bone marrow (BMAC), never donor “stem cell” products.
Honest about the evidenceResults are promising in some uses and limited in others, and no one should guarantee regeneration.
Know the red flagsPromises of cures, cartilage regrowth or “FDA registered” claims are warning signs.
What the FDA saysThe factsEvidenceRed flagsOur approachFAQsResearch

What the FDA says

“Regenerative medicine therapies have not 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.”
— U.S. Food and Drug Administration1

The FDA has warned consumers about the broad marketing of unapproved regenerative products, including stem cells, fat-derived cells (stromal vascular fraction), umbilical cord blood, amniotic fluid, Wharton’s jelly, ortho-biologics and exosomes. It has received reports of serious harm after these products, including blindness, tumor formation and infections, and notes that being told a product is “registered with FDA” or listed on a clinical trials website does not mean it is legally marketed.1

What is (and isn’t) a stem cell treatment

Stem cells (more precisely, mesenchymal progenitor cells) can develop into different tissue types in the laboratory. In the body, they are rare: bone marrow, the most commonly used source in orthopedics, contains only a small population of these cells mixed with many others.2 When a clinic advertises a “stem cell injection,” the product may be:

  • Your own bone marrow concentrate (BMAC). Contains marrow cells, including a small number of progenitor cells, plus growth factors.
  • Your own fat (adipose) tissue. Processed fat or stromal vascular fraction.
  • Donor products made from amniotic tissue, umbilical cord or Wharton’s jelly, which the FDA lists among unapproved regenerative products.1

Platelet-rich plasma (PRP) is not a stem cell treatment; it is a concentrate of platelets from your blood. Researchers have raised concerns about poorly characterized “stem cell” products, inadequate disclosure of risks and inappropriate marketing, and lawsuits have been filed over misrepresentation and informed consent.3

What the research shows

  • A systematic review of cell injections for knee arthritis and cartilage defects found improved outcomes and no major adverse events, but the improvement was modest, a placebo effect could not be ruled out and study quality was poor.4
  • In a placebo-controlled study, knees injected with BMAC and knees injected with saline improved similarly, and MRI showed no cartilage regrowth at 12 months.5,6
  • A systematic review found BMAC improved pain and function in knee arthritis but was not clearly better than PRP or placebo.7
  • In a 2025 study, BMAC made from patients’ own marrow produced a higher responder rate than cortisone, and the study’s authors reported greater responsiveness to patients’ own cells than to donor cell products.8
  • Some of the most encouraging results for bone marrow concentrate come from its use during surgery, such as rotator cuff repair, cartilage repair and hip osteonecrosis.9,10,11

Red flags to watch for

  • Promises to cure arthritis, regrow cartilage or guarantee you will avoid surgery
  • Claims that a product is “FDA registered” or listed on clinicaltrials.gov as proof it is approved1
  • Donor “stem cell” products (amniotic, umbilical, Wharton’s jelly or exosomes) sold for joint pain1
  • One treatment marketed for many unrelated conditions
  • Pressure to pay large sums up front, or seminars with free meals that end in a sales pitch
  • No examination by a physician, or no review of your X-rays and MRI
  • Testimonials offered in place of published research

Dr. Dold’s approach

  • Your own tissue only. Dr. Dold uses PRP from your blood and BMAC from your own bone marrow. He does not offer donor amniotic, umbilical cord or exosome products.
  • Accurate names. He describes BMAC as a bone marrow concentrate, not a “stem cell cure.”
  • Evidence first. He explains what the research shows for your specific condition, including when the evidence is weak, as on these pages.
  • The full range of options. As a surgeon who also offers non-surgical care, he can recommend physical therapy, injections or surgery based on what is most likely to help you.
  • No guarantees. Biologic treatments help many patients, but results vary.

Frequently asked questions

1.Can stem cell injections regrow cartilage in my knee?

There is no good evidence that injections regrow cartilage. In a placebo-controlled study, a BMAC injection did not change cartilage on MRI.6 Regrowing cartilage generally requires a surgical cartilage repair procedure.

2.Are amniotic or umbilical cord injections stem cell treatments?

They are often marketed that way. The FDA lists amniotic fluid, umbilical cord blood and Wharton’s jelly among regenerative products that are not approved and require FDA oversight in a clinical trial.1

3.Is BMAC safe?

BMAC is made from your own bone marrow during the same visit. It is not FDA-approved to treat any orthopedic condition, and Dr. Dold presents it as an evolving treatment. Very few complications have been reported with bone marrow harvesting.12

4.Will a stem cell injection help me avoid knee replacement?

That has not been proven. A 15-year study of bone marrow concentrate injected into the bone beneath the cartilage reported fewer knee replacements than injection into the joint,13 but no injection can guarantee you will avoid surgery.

5.Why do stem cell clinics charge so much?

Pricing varies widely, and these treatments are usually not covered by insurance.12 The FDA warns that being charged for unapproved products outside a clinical trial may mean you are being offered a product illegally.1

6.Is PRP a stem cell treatment?

No. PRP is a concentrate of platelets from your own blood.

7.How do I get an honest opinion?
Request an appointment or call 469-850-0680. Dr. Dold will examine you, review your imaging and explain all your options, including whether a biologic treatment makes sense.
Why see Dr. Dold
  • Board certified by the American Board of Orthopaedic Surgery, with subspecialty certification in Sports Medicine
  • Sports medicine and arthroscopy fellowship at NYU Langone / Hospital for Joint Diseases; orthopedic residency at the University of Toronto
  • Fellow of the American College of Surgeons (FACS), the American Academy of Orthopaedic Surgeons (FAAOS), the American Orthopaedic Association (FAOA) and the Royal College of Surgeons of Canada (FRCSC)
  • Has cared for professional and Olympic athletes from the NFL, NBA, NHL, MLS, PGA Tour, Major League Rugby and USA Gymnastics

Research cited on this page

  1. US Food and Drug Administration. Important Patient and Consumer Information About Regenerative Medicine Therapies. 2021. FDA
  2. Chahla J, Mannava S, Cinque ME, et al. Bone Marrow Aspirate Concentrate Harvesting and Processing Technique. Arthrosc Tech. 2017. PubMed
  3. Piuzzi NS, Emara A, Chahla J, et al. Ethical and Practical Considerations for Integrating Cellular ("Stem Cell") Therapy into Clinical Practice. Curr Rev Musculoskelet Med. 2020. PubMed
  4. Chahla J, Piuzzi NS, Mitchell JJ, et al. Intra-Articular Cellular Therapy for Osteoarthritis and Focal Cartilage Defects of the Knee: A Systematic Review of the Literature and Study Quality Analysis. J Bone Joint Surg Am. 2016. PubMed
  5. Shapiro SA, Kazmerchak SE, Heckman MG, et al. A Prospective, Single-Blind, Placebo-Controlled Trial of Bone Marrow Aspirate Concentrate for Knee Osteoarthritis. Am J Sports Med. 2017. PubMed
  6. Shapiro SA, Arthurs JR, Heckman MG, et al. Quantitative T2 MRI Mapping and 12-Month Follow-up in a Randomized, Blinded, Placebo Controlled Trial of Bone Marrow Aspiration and Concentration for Osteoarthritis of the Knees. Cartilage. 2019. PubMed
  7. Keeling LE, Belk JW, Kraeutler MJ, et al. Bone Marrow Aspirate Concentrate for the Treatment of Knee Osteoarthritis: A Systematic Review. Am J Sports Med. 2022. PubMed
  8. Mautner K, Kaiser JM, Boggess B, et al. Autologous Cell Injections for Knee Osteoarthritis Display Greater Responsiveness Than Allogenic Cellular Products and Corticosteroids in a Sex-Dependent Manner. Am J Sports Med. 2025. PubMed
  9. Hernigou P, Flouzat Lachaniette CH, Delambre J, et al. Biologic augmentation of rotator cuff repair with mesenchymal stem cells during arthroscopy improves healing and prevents further tears: a case-controlled study. Int Orthop. 2014. PubMed
  10. Gobbi A, Whyte GP. One-Stage Cartilage Repair Using a Hyaluronic Acid-Based Scaffold With Activated Bone Marrow-Derived Mesenchymal Stem Cells Compared With Microfracture: Five-Year Follow-up. Am J Sports Med. 2016. PubMed
  11. Hernigou P, Dubory A, Homma Y, et al. Cell therapy versus simultaneous contralateral decompression in symptomatic corticosteroid osteonecrosis: a thirty year follow-up prospective randomized study of one hundred and twenty five adult patients. Int Orthop. 2018. PubMed
  12. American Academy of Orthopaedic Surgeons. Concentrated Bone Marrow Aspirate for Knee Osteoarthritis: Technology Overview. 2021. Read the overview (PDF)
  13. Hernigou P, Bouthors C, Bastard C, et al. Subchondral bone or intra-articular injection of bone marrow concentrate mesenchymal stem cells in bilateral knee osteoarthritis: what better postpone knee arthroplasty at fifteen years? A randomized study. Int Orthop. 2021. PubMed
Still have questions? Dr. Dold is a board-certified orthopedic sports medicine surgeon who offers PRP and BMAC and gives patients an honest picture of the evidence. Request an appointment or call 469-850-0680. Walk-in visits are welcome Monday, Wednesday and Friday, 8:30–10:30 am, at 6700 Dallas Parkway, Suite 100, Frisco.

Medically reviewed by Andrew P. Dold, MD, FAOA, FAAOS, FACS, FRCSC. Last reviewed October 2026. This page is general information, not medical advice. PRP and BMAC are not FDA-approved to treat any specific orthopedic condition, and results vary.

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