Regenexx FAQ

A: 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.

A: In November of 2015, physicians in the Regenexx network were asked to share their experience with the company and their revolutionary stem cell procedures. Here are their stories.

A: 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 many things that set Regenexx procedures apart from all other stem cell therapy being offered is dosage; to ensure the best possible outcome the doctor takes many factors into consideration, including your stem cell count.

A: When we first began offering orthopedic stem cell therapy in 2005 as part of an IRB approved medical study, we were one of the few clinics in the world treating orthopedic problems with stem cells. When we began treating everyday patients in 2007, this was still the case. Now other clinics are beginning to offer basic cell therapies, most in plastic surgery and cosmetics, with a few clinics just starting to try orthopedic therapies. While we welcome the growth in cell based medicine, we also know that we’re world leaders in this area. As leaders, we set a higher standard for ourselves in all of the cell-based procedures we offer our patients.

We have 2 pages dedicated to explaining the substantial differences between Regenexx and other stem cell solutions:

The Regenexx Difference

An In-Depth Look at the Differences

A: No. PRP is concentrating platelets in the blood, not stem cell therapy. This is a more detailed discussion on the differences between PRP and stem cell therapy. In addition, while PRP is one component of the therapy, we use a very different “Super Platelet Mix’ which we believe helps to produce many more stem cells.

We do offer the Regenexx® Super Concentrated Platelet Rich Plasma Procedure, which is a platelet procedure that is quite different from the bloody PRP commonly available using bedside centrifuges. To see a patient infographic on these differences, see this link for general info on the Regenexx platelet procedure and this one for a comparison between our process and typical bedside PRP machines.

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

A: The same day procedure involves taking cells and then isolating those over one day.

The cultured procedure grows those cells to larger numbers over a period of a few weeks.

A: Call us to schedule a phone review of your images with one of our doctors or schedule an appointment with one of our approximately 30 Regenexx Network sites around the country.

A: We carefully hand pick only the doctors who have the base skills to perform these procedures, which means we turn most away. We then train our physicians with an intensive education program.

A: That depends on which procedure is performed.

For example, for knee arthritis, you can expect 3 days of significant down-time followed by a slow return to normal activities over 6 weeks. While you may be asked to wear a brace, very few of our procedures require crutches.

A: Many mechanisms have been put forth, including long-term blocking of cells that destroy the joint, rescue of cells that fix the joint, and replacing lost native stem cells that maintain the joint.

A: No, while we have seen MRI evidence of cartilage growth in mild and moderate arthritis, we generally don’t see it with severe arthritis.

A: 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.

Typical Condition Severity

$$$ Cultured Stem Cell Procedure (Cayman Islands Only)*

$$ Stem Cell Treatment Protocol (USA & Worldwide)

$ Platelet Rich Plasma & Platelet Lysate

Strains, muscle, ligament & tendon tears, overuse injuries, tendonitis & tendonosis, minor arthritis, joint maintenance, bulging or herniated discs, degenerative discs.

More severe muscle, ligament & tendon tears (including complete tears), joint arthritis, degenerative joint conditions, torn spinal discs, degenerative discs, avascular necrosis, bone conditions & non-union fractures.

Similar to USA Stem Cell Treatment, but stem cells are cultured to greater numbers.* Recommended for severe injuries, arthritis, advanced degenerative conditions, more severe spine conditions.

*Advanced culture expanded stem cell procedure-not approved by the USFDA and available only through licensed sites where culturing cells are the practice of medicine.

A: 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.

A: While we prefer to see someone in person to review their condition and evaluate whether they would be a good candidate for Regenexx, many of our network doctors offer an initial phone review of your condition if it’s inconvenient for you to drive to your nearest provider for an office visit.

The doctor can look at your films, history, and speak to you on the phone about whether he or she believes this may help your problem. It’s important to note that this is not the formation of a traditional doctor–patient relationship until you actually visit the doctor. Rather, this is just an opportunity for the doctor to determine if you’re a reasonable candidate for the procedure and for you to ask addition questions.

The doctor will require an MRI on CD / DVD or an uploaded version of your MRI in order to review your imaging. Check with your local Regenexx provider on how to deliver your MRI to them.

There is a charge for phone reviews with a Regenexx doctor, so check with your local Regenexx Provider to learn more.

A: If your clotting times are normalized by taking clotting factors, then there should be no problem performing the procedure.

A: If you are under 110 pounds in weight, the doctor will likely decide to take less marrow or blood.

A: If your hematocrit is below 30 or your hemoglobin is below 10, we may not be able to perform the procedure. If your hematocrit is between 30-36 or hemoglobin below 12, we may try to limit the IV blood or marrow draw amounts and will have you follow-up with your family doctor.

A: 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.

A: Because an x-ray will only show the condition of the bone, not the soft tissue, the doctor needs an MRI to accurately evaluate the condition of the whole area. If a patient is unable to have an MRI, a CT arthrogram is acceptable. We will review an x-ray for non-union fractures only.

The doctor will need the most recent MRI available. The MRI should be without contrast and less than two years old. If you’ve had surgery or a scope done since having the MRI, we would need an MRI that was taken after the operation / procedure.

A: MSC’s do stay localized to the injection site across multiple studies. This is likely linked to the fact that they generally do not circulate in the blood stream like other adult stem cell types and are primarily found resident in the tissues they serve.

A: Mesenchymal stem cells will stop proliferating when they physically contact each other (otherwise known in cell culture lingo as “confluence”). Culturing these cells, it becomes obvious that once they reach that point, they refuse to continue to grow (proliferate). This is because they are repair cells and when an area in need of repair is fully covered, they get the signal to stop growing. In patients where we have ongoing MRI surveillance of the re-implant sites, there has been no evidence of overgrowth where the regeneration has surpassed “expected optimal growth”.

A: Unlike embryonic stem cells, adult stem cells do not generally keep growing, even in culture. For example, most patients whose stem cells we grow to bigger numbers in the lab will lose their ability for continued cell growth after just a few weeks. In addition, the same body signals that would tell these cells to stop growing in healing a normal fracture or ligament tear are still present in your body.

A: No, an analysis of the published research shows that liposuction is more risky than a bone marrow aspirate. More information on this can be found at the link below:

https://www.regenexx.com/whats-more-risky-bone-marrow-aspiration-or-liposuction/

A: Approximately 10 years.

A: 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 it’s type by a meta-analysis that appeared in the prestigious medical journal, Osteoarthritis and Cartilage.

View the current safety data for our procedures…

A: The basic science on adult stem cells shows that if the cells are kept in culture for short periods, there is no risk of the cells becoming cancerous. 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. Finally, we maintain an extensive complications tracking database with patient contacts at specified times. We have seen no evidence of significant complications at these re-implant sites. We also work with an outside lab for quality to clear each patient’s cells before they are used in treatment as an additional safety check.

A: 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.]

A: Many patients ask why we need to draw blood and how much is taken. Blood is drawn from a vein in your arm and the amount drawn can vary significantly based on the type of procedure and your body weight, we also do a blood draw for the post-injection portion of our stem cell procedure protocol. The growth factors that we use to grow your stem cells and enhance your procedure are contained in your blood platelets. These same growth factors and blood platelets are used for our platelet rich plasma and platelet lysate procedures. More information on platelet procedures can be found here.

A: The cells are isolated in the lab using a proprietary separation technique. For the same day procedure, this isolated stem cell fraction is placed right back into the body. For more details on the stem cell procedure.

A: 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.

A: There is virtually no down time with this outpatient procedure. The entire process will take anywhere from 2-8 days depending on the doctor’s recommendation. You can walk right out of the clinic the same day any procedure is completed. For all blood-derived procedures (SCP, PL), you will only need to come in for one day for treatment.

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

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

A: Patients often confuse a bone marrow aspirate with a more involved and more painful bone marrow biopsy.

We only perform the less involved and much more comfortable bone marrow aspirate. This is a short (20 to 40 minute) in office procedure where the skin and tissues are numbed and a needle is used to withdraw marrow blood, which contains the stem cells. One site on each will be numbed and three samples are taken from each site. Because the area is extensively numbed, 88% of our patients report that the procedure is very comfortable and would do it again.

To better access how our patients feel about this procedure, we ran questionnaires on 44 consecutive patients undergoing marrow draws (primarily in Jan-Feb 2009). 86% said they had no to mild discomfort. 88% said that the procedure was either less uncomfortable or about what they thought it would be. 88% also said they would do it again without hesitation.

A properly performed marrow aspirate procedure should not be uncomfortable to the vast majority of patients.

A: Yes, we ask that all patients either use a home infra-red unit or another type of ultrasound unit to help with cell growth. The infra-red unit is available through Active Forever https://www.activeforever.com/

A: 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.

A: 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 healing 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.

A: Yes, we have developed our own supplement based on lab tests with human mesenchymal stem cells and their response to various nutritional supplements.

A: Some of our patients will require a second or even third procedure. Our usual protocol involves 1-3 injection cycles. Most patients get a single procedure.

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