Are the Regenexx procedures performed in the U.S. approved by the FDA?

by Josh V /

No; they are exempt from FDA regulation.

Each of the Regenexx procedures available in the United States involves the patient’s own bone marrow or blood, and the Regenexx network of doctors only treat musculoskeletal conditions. Further, none of the Regenexx procedures available in the United States involves the culture expansion of the patient’s cells to create larger number of cells. Thus, the Regenexx procedures available in the United States generally fall into the following regulatory exemptions:

  • For our procedures involving concentrated bone marrow, minimally manipulated bone marrow for homologous use is not subject to FDA regulation as a human cell, tissue, or cellular or tissue-based product (HCT/P); 21 CFR 1271.3(d).
  • For our procedures involving autologous blood (such as PRP), practitioners who are licensed by law to prescribe or administer drugs and who manufacture blood products solely for use in the course of their professional practice are not subject to FDA regulation; 21 CFR 607.65.
  • Procedures involving the removal of an HCT/P from a patient and the implantation of that same HCT/P back into the same patient during the same surgical procedure are not subject to FDA regulation; 21 CFR 1271.15(b).

Regenexx is proud of its history of regulatory compliance and is deeply familiar with the regulatory environment in which it operates. If you have any questions about our regulatory compliance, please feel free to ask and we will be happy to speak with you in further detail.

[Disclaimer: The Regenexx® same-day procedures are performed in the United States. The Regenexx-C cultured stem cell procedure is only offered outside the U.S. through independently owned and operated medical services providers operating exclusively in countries that allow autologous cultured cells to be used through their local regulatory structure. These service providers are not part of nor affiliated with the Centeno-Schultz Clinic nor any U.S. Regenexx Network provider. The Regenexx-C procedure licensed by these entities is not approved by the U.S. FDA for use in the United States.]

Category:
Regenerative procedures are commonly used to treat musculoskelatal trauma, overuse injuries, and degenerative issues, including failed surgeries.
Select Your Problem Area
Shoulder

Shoulder

Many Shoulder and Rotator Cuff injuries are good candidates for regenerative treatments. Before considering shoulder arthroscopy or shoulder replacement, consider an evaluation of your condition with a regenerative treatment specialist.

  • Rotator Cuff Tears and Tendinitis
  • Shoulder Instability
  • SLAP Tear / Labral Tears
  • Shoulder Arthritis
  • Other Degenerative Conditions & Overuse Injuries
Learn More
Cervical Spine

Spine

Many spine injuries and degenerative conditions are good candidates for regenerative treatments and there are a number of studies showing promising results in treating a wide range of spine problems. Spine surgery should be a last resort for anyone, due to the cascade of negative effects it can have on the areas surrounding the surgery. And epidural steroid injections are problematic due to their long-term negative impact on bone density.

  • Herniated, Bulging, Protruding Discs
  • Degenerative Disc Disease
  • SI Joint Syndrome
  • Sciatica
  • Pinched Nerves and General Back Pain
  • And more
Learn More
Knee

Knees

Knees are the target of many common sports injuries. Sadly, they are also the target of a number of surgeries that research has frequently shown to be ineffective or minimally effective. Knee arthritis can also be a common cause for aging athletes to abandon the sports and activities they love. Regenerative procedures can be used to treat a wide range of knee injuries and conditions. They can even be used to reduce pain and delay knee replacement for more severe arthritis.

  • Knee Meniscus Tears
  • Knee ACL Tears
  • Knee Instability
  • Knee Osteoarthritis
  • Other Knee Ligaments / Tendons & Overuse Injuries
  • And more
Learn More
Lower Spine

Spine

Many spine injuries and degenerative conditions are good candidates for regenerative treatments and there are a number of studies showing promising results in treating a wide range of spine problems. Spine surgery should be a last resort for anyone, due to the cascade of negative effects it can have on the areas surrounding the surgery. And epidural steroid injections are problematic due to their long-term negative impact on bone density.

  • Herniated, Bulging, Protruding Discs
  • Degenerative Disc Disease
  • SI Joint Syndrome
  • Sciatica
  • Pinched Nerves and General Back Pain
  • And more
Learn More
Hand & Wrist

Hand & Wrist

Hand and wrist injuries and arthritis, carpal tunnel syndrome, and conditions relating to overuse of the thumb, are good candidates for regenerative treatments. Before considering surgery, consider an evaluation of your condition with a regenerative treatment specialist.
  • Hand and Wrist Arthritis
  • Carpal Tunnel Syndrome
  • Trigger Finger
  • Thumb Arthritis (Basal Joint, CMC, Gamer’s Thumb, Texting Thumb)
  • Other conditions that cause pain
Learn More
Elbow

Elbow

Most injuries of the elbow’s tendons and ligaments, as well as arthritis, can be treated non-surgically with regenerative procedures.

  • Golfer’s elbow & Tennis elbow
  • Arthritis
  • Ulnar collateral ligament wear (common in baseball pitchers)
  • And more
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Hip

Hip

Hip injuries and degenerative conditions become more common with age. Do to the nature of the joint, it’s not quite as easy to injure as a knee, but it can take a beating and pain often develops over time. Whether a hip condition is acute or degenerative, regenerative procedures can help reduce pain and may help heal injured tissue, without the complications of invasive surgical hip procedures.

  • Labral Tear
  • Hip Arthritis
  • Hip Bursitis
  • Hip Sprain, Tendonitis or Inflammation
  • Hip Instability
Learn More
Foot & Ankle

Foot & Ankle

Foot and ankle injuries are common in athletes. These injuries can often benefit from non-surgical regenerative treatments. Before considering surgery, consider an evaluation of your condition with a regenerative treatment specialist.
  • Ankle Arthritis
  • Plantar fasciitis
  • Ligament sprains or tears
  • Other conditions that cause pain
Learn More

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*DISCLAIMER: Like all medical procedures, Regenexx® Procedures have a success and failure rate. Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our treatments for anyone else.

Providers listed on the Regenexx website are for informational purposes only and are not a recommendation from Regenexx for a specific provider or a guarantee of the outcome of any treatment you receive.