Regenexx FAQs

General

+ Phone review of your condition

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.

+ What if I have a blood clotting disorder?

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

+ Are there weight limits for the marrow aspirate for blood draw?

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

+ What if I have anemia?

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.

+ How long has Regenexx been doing these procedures?

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.

+ X-Ray vs. MRI

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.

+ What do I need to know about Stem Cells?

Yes, there are many types of 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.

+ Do mesenchymal cells stay localized to the injection site? Is there any risk of them traveling throughout the 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 blood stream like other adult stem cell types and are primarily found resident in the tissues they serve.

+ What triggers the cessation of cell growth during regeneration? Has regeneration ever surpassed expected optimal growth?

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”.

+ How will my stem cells know when to stop growing?

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.

Safety / Compliance

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+ Is a fat liposuction safer than a bone marrow aspirate?

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 here.

+ What has the longest time period of observation that leads you to conclude there is no tumor risk?

Approximately 10 years.

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

The FDA does not “approve” or “not approve” medical procedures (like gall bladder surgery for example). This is considered a medical procedure.

The Regenexx procedures performed in the United States are compliant with CFR 21 Part 1271 and fall under the same surgery exemption discussed in 1271.15 (b).

All of the Regenexx Stem Cell and Blood Platelet Procedures performed in the U.S. today are same-day procedures that are compliant with CFR 21 Part 1271, falling under the same surgery exemption discussed in 1271.15 (b).

The Regenexx-C Procedure – What’s the Difference?

All of the procedures performed throughout our U.S. Regenexx Procedure Network are same-day procedures. This means that the patient’s cells are harvested in the morning, isolated and processed, then re-injected into the patient’s injured area – all within a period of a few hours. This makes them compliant with CFR 21 Part 1271, falling under the same surgery exemption discussed in 1271.15 (b).

Regenexx®-C is a cultured stem cell procedure that is available only in the Cayman Islands. While our same-day stem cell protocol (described above) is the premier stem cell treatment available in the United States, some patients may benefit from the expanded numbers of cells that are delivered by a cultured stem cell procedure.

The Regenexx-C Procedure, which is only performed at Regenexx Cayman, involves harvesting the cells on the patient’s first visit, growing them to larger numbers over approximately two weeks, testing cells, then re-injecting the cells during the patient’s second visit.

[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.]

Procedures

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+ Blood Draws - What to Expect

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.

+ What happens to stem cells after you take them out?

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.

+ Do I need to have someone drive me?

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.

+ How long do I have to stay for the procedure?

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.

+ How do you know where to place the cells?

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

+ How painful is the procedure for implanting stem cells?

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

+ What should I know about the bone marrow aspirate?

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.

Recovery

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+ Is there anything else that you need me to do help the cells?

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.

+ Is physical therapy needed after the procedure?

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.

+ When can I return to normal activity?

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.

+ Should I take specific supplements after my produre?

Yes, we have developed our own supplement based on lab tests with human mesenchymal stem cells and their response to various nutritional supplements. Click here for more info

+ Will I need a second procedure?

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.

+ When can I expect to feel better?

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