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Regenexx Procedure FAQ

General

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.

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.

Are these embryonic stem cells?

No, they are simply your own adult stem cells. We only use autologous (your own) cells.

Are umbilical cord stem cells better than adult stem cells?

Cord stem cells are stem cells isolated from a baby’s umbilical cord. While they may be more biologically active because of their young age, recent research has suggested that they can also transmit genetic diseases that the baby may carry. Until these issues are further sorted out (likely with better genetic testing), we would advise against using any donor stem cells to treat non-life threatening disease. (cells from another person). This would include cord cells, embryonic stem cells, or someone else’s adult stem cells.

To learn more about this topic, see this YouTube presentation produced by Dr. Centeno.

Are there different types of adult stem cells?

Yes, there are many types of adult stem cells. The most common is known as a hematopoetic stem cells (HSC-CD 34+). These are easy to obtain from IV mobilized blood (where a special medicine is given to the patient first to push these cells out of the bone marrow) or bone marrow and are very plentiful. Outside of a handful of cardiac and vascular applications, they are not well studied as being effective in treating a broad range of diseases. Despite this, the vast majority of what you see being billed as “stem cells” from bone marrow (where the cells are injected the same day as collected) are these less useful cells. The type of adult stem cell that is most often seen in research as being associated with orthopedic tissue repair is a mesenchymal stem cell (MSC). MSCs can’t generally be harvested from blood. Fat tissue contains many MSCs, but these are distant cousins to the type obtained from bone marrow and aren’t as useful for orthopedic applications. For more more information on why stem cells from fat aren’t as useful as those from marrow to treat orthopedic injuries, click here. For an easy to understand patient infographic on why bone marrow stem cells are better than fat cells for orthopedic tissue repair, click here.

What are there different types of Mesenchymal Stem Cells (MSC’s)?

For orthopedic applications, two main types of MSCs have been used, bone marrow derived and adipose (fat) derived. Bone marrow MSCs are taken via a needle through a bone marrow aspirate. The bone marrow aspiration procedure sounds like a big deal, but we are consistently told by patients that the procedure is very comfortable. The second type of MSC is derived from fat tissue (adipose). This can be obtained via liposuction. For orthopedic applications, fat derived MSCs consistently and dramatically under perform bone marrow derived cells. In studies of cartilage repair, bone repair, and soft-tissue repair, bone marrow derived MSCs are much more adept at these tasks. This makes sense, as they perform this function naturally (homologous) everyday. For example, if you break a bone, it’s these bone marrow MSCs that help mend that bone. In addition, for surgical micro fracture to repair small amounts of knee cartilage damage, it’s bone marrow MSC’s that are released to do that job.

Doesn’t fat (adipose tissue) have more stem cells than bone marrow?

Yes and No. First, many adipose stem cell clinics dramatically over-estimate the number of stem cells in their processed fat. This is a good hard core science review of the kits often used by physicians which over estimate these numbers. Basically, what physicians believe to be cells are actually small globs of fat tissue. Second, the proprietary Regenexx stem cell isolation method dramatically increases the number of stem cells isolated from bone marrow (based on our lab studies).

Still, on a weight to weight basis, fat can contain more mesenchymal stem cells than bone marrow, but the problem is that they just don’t work as well for orthopedic applications. In addition, in the Regenexx-AD knee stem cell procedure we offer the best of both worlds, bone marrow and fat.

For an easy to understand patient infographic on why bone marrow stem cells are better than fat cells for orthopedic tissue repair, click here.

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.

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”.

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.

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 bloodstream like other adult stem cell types and are primarily found resident in the tissues they serve.

Safety & Compliance

Certain types of medications will negatively impact the stem cells. In addition, we generally see that many prescription medications will reduce stem cell number.

We generally recommend that you stop these before the procedure. For example, if you take Coumadin, you need to have the OK of your family doctor or cardiologist to come off this drug and an INR (blood clotting test) that is in the normal range before pursuing this procedure. If you take other blood thinners such as Plavix, you should be off this drug for 72 hours prior to the procedure. Your family doctor or cardiologist may also need to be consulted to ensure that it’s safe to come off of this medication. If you take a daily baby aspirin, then you need to come off this one week before the procedure.

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

Approximately 10 years.

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…

No, an analysis of the published research shows that liposuction is riskier than a bone marrow aspirate. More information on this can be found here.

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.

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.]

Medications

Certain types of medications will negatively impact the stem cells. In addition, we generally see that many prescription medications will reduce stem cell number.

We generally recommend that you stop these before the procedure. For example, if you take Coumadin, you need to have the OK of your family doctor or cardiologist to come off this drug and an INR (blood clotting test) that is in the normal range before pursuing this procedure. If you take other blood thinners such as Plavix, you should be off this drug for 72 hours prior to the procedure. Your family doctor or cardiologist may also need to be consulted to ensure that it’s safe to come off of this medication. If you take a daily baby aspirin, then you need to come off this one week before the procedure.

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

We produced the Regenexx Advanced Stem Cell Support Formula to support healthy stem cell function and cartilage production. Learn more or buy the supplement here.

Effectiveness / Outcomes

Regenexx® stem cell procedures have been studied extensively for more than a decade and our patients are part of the world’s largest human mesenchymal stem cell re-implantation database for orthopedic purposes. We regularly publish outcome data from this patient registry and make it available to the public.

Our analysis of patients who have had a second procedure shows that very often a second procedure can help continue and improve the success a patient has from our regenerative treatments. See our results.

Procedure - What to expect

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

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.

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, click here.

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.

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

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.

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.