FAQ

As many as 7 out of 10 current orthopedic surgeries1, without fracture-related care, could be avoided with a Regenexx procedure. Radiologists and doctors can miss crucial information on your MRI or X-ray if they don’t spend enough time with you and analyzing your film.2,3,4,5 Imaging is very important, but it’s only one part of reaching a diagnosis.

Most of the people we see are:

• Considering treatment that involves risks or could have significant consequences.
• Unsure about a diagnosis or treatment plan from another doctor.
• Struggling with a condition that’s not improving.
• Trying to make an informed decision about musculoskeletal health care for themselves or their family.

Some of the most common issues we see and treat are:

Regenexx conducted clinical trials from 2005 – 2007, which were the first orthopedic stem cell procedures performed. Since that time, Regenexx has performed more of these procedures than any other clinic or medical group.

For most post patients, results should become apparent over 1-3 months but sometimes can take as long as 6-9 months. We have been collecting patient outcome data for quite some time and we regularly and openly publish the results with the public. You can view the data on our results page.

The entire process takes anywhere from 2-8 days, depending on the doctor’s recommendation. However, the procedure itself is a same-day procedure, hurts only as much as a typical shot at a doctor’s office, and you can walk right out of the clinic after it’s completed.

This depends on the type of procedure. However, all of our procedures are designed to promote as much early activity as possible. Here is a general guide:

• Joint procedure: If there is more minimal cartilage loss, low impact activities would be encouraged immediately after the procedure. Full high impact activities would be expected at 4-6 weeks.
• Partial tendon/ligament/muscle tear: Low impact activities would be encouraged immediately after the procedure. Full high impact activities would be expected at 4-6 weeks.
• Bone procedure (for fracture non-union or avascular necrosis): You must be off the area on crutches until the pain from the procedure subsides. You can then move toward slowing increasing activities over the next few weeks. Total time off the area for most patients is 1-3 weeks with normal activities at about 6 weeks. The only exception is when there is an existing rod or plate stabilizing the fracture site, in these cases you will be allowed more activity more quickly.

Regenexx procedures 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.]

Using the HHS OHRP guidelines for complications reporting, our complications to date have been in the mild to moderate category and rare.

• Mild: requires no medical treatment. For example transient swelling.
• Moderate: requires treatment. For example, opting for a treatment other than a Regenexx procedure if it failed.

We have published the world’s largest (to date) safety and complications tracking study of adult stem cell use in patients. This study did not show any serious stem cell-related complications and it did not show that any patient developed a stem cell-related cancer.

In addition, our most recent safety paper was named the best of its type by a meta-analysis that appeared in the prestigious medical journal, Osteoarthritis, and Cartilage.

View the current safety data for our procedures.