Frequently Asked Questions About Regenexx Procedures

Top Questions

The results should become apparent over 1-3 months but sometimes can take as long as 6-9 months.

You can walk right out of the clinic the same day any procedure is completed. The entire process will take anywhere from 2-8 days depending on the doctor’s recommendation.

We do. We have been collecting patient outcome data for quite some time and we regularly and openly publish the results with the public. To view this data, visit our Outcomes Page.

This is on a case-by-case basis and although we have before, it would be at the advice of the doctor to treat more than one area. One of the key things that set Regenexx procedures apart is dosage. To ensure the best possible outcome the doctor takes many factors into consideration, including your stem cell count. Click here to learn about conditions treated.

Our registry-based research has shown that, for stem cell procedures, older age does not adversely impact outcome.

PRP and stem cell injections are not covered by insurance at this time. However, Regenexx is the only regenerative orthopedic procedure in America that has insurance coverage through some self-funded employers. If you would like to find out if your employer currently covers Regenexx, complete this form and we will respond to you as soon as possible.

Additionally, health insurance plans may cover the initial evaluation. If your plan does, and we are part of your insurance carrier network, we will bill the carrier. If not, there will be a consultation fee for the initial face to face consult.

We recommend that you contact your insurance carrier for more information about your specific coverage details.

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.]

Safety

Using the HHS OHRP guidelines for complications reporting, our complications to date have been in the mild to moderate category and rare. This means that either the complication (like transient swelling) required no medical treatment (Mild), or if it did require medical treatment, the treatment was simple (Moderate-like a patient who failed the procedure who ultimately decided to get the knee replacement that he or she was planning before the procedure).

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.

Outcomes

We originally 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. The same-day procedure that is currently performed in the United States was developed in 2010 and has been continually improved since that time.

Cost

No, these procedures are too new to be covered yet. Don’t let someone fool you, PRP and stem cell injections have no insurance coverage at this time.

Some health insurance plans may cover the initial evaluation. If your plan does, and we are part of your insurance carrier network, we will bill the carrier. If not, there will be a consultation fee for the initial face to face consult.

We recommend that you contact your insurance carrier for more information about your specific coverage details.

Because the procedure protocol will vary from person to person and because each person will have a unique condition to be treated, the pricing of procedures can vary considerably from patient to patient. An evaluation will give you a better idea of condition, treatment, and costs specific to your condition. The chart below provides a general idea of the procedures and where they fall in terms of cost and severity of conditions treated. Platelet procedures cost considerably less than stem cell procedures.

Procedure

About as painful as a typical shot in a doctor’s office.

We use real-time x-ray known as fluoroscopy or musculoskeletal ultrasound. Your MRI images are used to help plan that injection.

All of our patients walk out of the clinic. However, having someone drive you for a medical procedure is never a bad idea. On occasion, a local nerve block may be used, which could impair your ability to drive safely, so you should consult with your doctor or clinic about your specific treatment and protocol to ensure that it will be safe for you to drive if you wish to do so.

Recovery

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:

  • 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.
  • 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.

In general, we always try to look at more than one injured part. As a result, it’s very likely we will recommend other types of conservative care to restore normal biomechanics. This might include physical therapy, different types of myofascial release, or specific home exercises.

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CONTACT INFORMATION

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9035 Wadsworth Pkwy #1000
Westminster, CO 80021

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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.

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