FAQ’s

Here we list the most commonly asked questions, so you can get answers before you speak with a Regenexx™ procedure doctor.

When a physician performs a stem cell therapy in the ordinary course of his or her medical practice, must that therapy be FDA-approved?

The Food and Drug Administration’s (FDA) power to regulate in the public interest must always be grounded in a valid grant of authority from Congress. Between 1906 and today, Congress has granted authority to the FDA on dozens of occasions to regulate food, drugs, cosmetic products, biological products, radiation-emitting products, and veterinary products. Congress has never, however, granted the FDA the authority to regulate the practice of medicine. Indeed, it is well settled that the individuals retain the power to regulate professions, including the practice of medicine.

RSI consists of two physicians who operate a small medical facility in Broomfield Colorado and treat patients there. Both of RSI’s physicians are licensed to practice medicine in the State of Colorado and all of RSI’s patients are treated exclusively inBroomfield. RSI’s surgical procedure involves the use of autologous stem cell therapies (ACTs) which involve the in vivo use of a patient’s own stem cells, following in certain circumstances, ex vivo processing for the treatment of the patient’s injuries. The procedures performed by RSI, including surgery and bone marrow re-implants, are not performed as part of any research intended for FDA approval of a product that is under the jurisdiction of the FDA. Rather, RSI’s physicians perform these procedures exclusively as part of their medical practice and in a one-on-one capacity with their patients. Consequently, these procedures are considered the “practice of medicine,” and left up to individual surgeons’ judgment and experience and oversight by the Colorado Board of Medicine. Consequently, because the FDA does not have the jurisdiction to regulate the practice of medicine, it likewise lacks the jurisdiction to regulate these procedures.

A simpler Explanation:

The restaurants at which we dine on a daily basis are not regulated by the FDA. Why? First and foremost, the United States Congress has not given such jurisdiction to the FDA. Instead, Congress has left the regulation of restaurants to the departments of health in the states where the restaurants are located.

Congress has made this choice for a variety of reasons. First of all, the departments of health of the independent states are perfectly competent to regulate the services we receive on a one-on-one basis. This applies equally at your local barbershop, restaurant, hospital, and doctor’s office. At a restaurant, the public health risk of tainted food is a one on one risk. At worst, a restaurant with a substandard kitchen might make a few people ill. For this reason, both the restaurant and the doctor are regulated at the state level.

Now let’s say our restaurant has a popular menu item that it wants to place in jars and ship across state lines to customers placing orders. All of a sudden the public health risk escalates dramatically. The food in jars shipped nationwide has the potential to make huge numbers of people ill with just one tainted batch. In such circumstances, the restaurant is no longer just a restaurant. Instead, the restaurant has become a food production facility, the public health risk has become a federal one, and the FDA thus has the jurisdiction to regulate it. The same holds true if a doctor’s office decides to place stem cells in a vial and ship those to other doctors in other states. Indeed, just like the restaurant mass producing food and shipping it around the country, the public health risk is much larger and involves potentially all 50 states.

While there is no doubt that we would all want the FDA to have regulatory authority over stem cells shipped in a vial, what would happen if we had FDA regulate restaurants? Since every kitchen would need cGMP kitchen (meaning up to the standards of mass food production) the cost of eating out would become prohibitively expensive. A ten thousand dollar prime rib anyone? Similarly, what would happen if FDA regulated your doctor? The cost of delivering medical care would skyrocket in cost but plummet in speed and effectiveness. Indeed, if the FDA did in fact regulate your physician, every time you visited him for a treatment, that treatment would have to undergo a 7-10 year FDA approval before you could receive it. Just as there is no public health rationale for having FDA regulate restaurants, there is also no public health reason for FDA to regulate your doctor’s medical practice.

Is this the same as PRP (platelet Rich Plasma)?

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.

Is this treatment the same as “same day” stem cell therapy where my bone marrow or stem cells are spun down in a centrifuge?

No.  The Regenexx procedure involves growing the stem cells to bigger numbers in a state of the art lab over a number of weeks.  For more info on differences between the Regenexx procedure and same day stem cell therapies (or BMAC), see this link.

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?

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. (cells from another person). This would include cord cells, embryonic stem cells, or someone else’s adult stem cells.

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+). While these are easy to obtain from IV blood 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 disease. Despite this, the vast majority of what you see being billed as “stem cells” (where the cells are injected the same day as collected from bone marrow or blood) are these less useful cells. The type of adult stem cell that is most often seen in research as being associated with tissue repair is a mesenchymal stem cell (MSC). MSC’s can’t generally be harvested from blood nor can they be obtained in clinically relevant numbers at the bedside, processed, and re injected in the same day. All of the high quality research involving MSC’s involves culture expansion. This means that the cells are grown in culture to higher numbers before being used for treatment. This usually takes 10-18 days.

Are there different types of MSC’s?

Yes. For orthopedic applications, two main types of MSC’s have been used, bone marrow derived and adipose derived. Bone marrow MSC’s 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 MSC’s consistently and dramatically under perform bone marrow derived cells. In studies of cartilage repair, bone repair, and soft-tissue repair, bone marrow derived MSC’s 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 MSC’s 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.

Conditions

What types of problems can be treated?

Fractures that have failed to heal, joint cartilage problems, partial tears of tendons, muscles, or ligaments, chronic bursitis, avascular necrosis of the bone, and lumbar disc bulges.

What body areas have you treated?

Knee, hip, shoulder, ankle, hand, foot, and low back.

Do you treat spinal cord injury?

Not at this time.

Do you treat any other problems outside of bone, tendon, muscle, joint, or ligament?

Not at this time.

Do you treat heart or vascular problems?

Not at this time.

What is the success rate? How many people respond? What is the cure rate?

In a recent survey approximately 80% of the patients who responded said that they were satisfied with their treatment and would do it again. More detailed data from early patients has also been collected. The following is in knee and hip patients with severe arthritis who were told they needed a joint replacement surgery:

-89% of knee patients reported more than 50% relief of symptoms and more than half of them had greater than 75% relief.
-75% of hip patients reported more than 50% relief and 88% of them reported more than 75% relief

We are continuing to review patient outcomes, so check back for updated results. In addition, individual case reports (often with before and after MRI images) can usually be found at http://www.regenexx.com/global-navigation/regenexx-blog/

Does the Regenexx procedure always work?

NO. All medical and surgical procedures have a success rate. This procedure is no different. We do see patients who do not respond. Please take a minute to review a more detailed discussion on this topic by clicking here.

How many procedures have you performed?

As of December 31 2009, there has been 333 separate patients that have been treated with the Regenexx ™ Procedure and a total of 754 reinjection procedures (Many patients receive multiple reinjections).

Marrow Draw

Is a bone marrow draw painful?

Because we extensively numb the area, about 8 in 10 patients say that the marrow draw was not painful and would do it again. For more info on this topic, see http://www.regenexx.com/2009/03/is-a-properly-done-marrow-draw-painful/

What about the patients who thought the marrow draw was painful?

If you have a history of chronic low back pain, more discomfort can be expected. In that case, the doctor may offer you an epidural injection to better numb the area.

How long does a marrow draw take?

20-40 minutes

How is a marrow draw done?

The skin and tissues are numbed, then a needle is used to draw thick blood (whole marrow) and this is sent to the lab.

Do you take marrow blood from more than one site?

One skin site on each side will be numbed and three samples are taken from each of those sites.

What if I have anemia?

If your hematocrit is below 30 or your hemoglobin is below 10, will 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.

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.

What if I take Coumadin, Plavix, or other blood thinners?

We would 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 tests) that is in the normal range before pursuing this procedure. If you take other blood thinner 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.

Blood Draw

How much blood will you take from my vein?

A total of 300-500 cc will be drawn (about a pint).

Why do you need to draw blood from a vein?

The growth factors that we use to grow your stem cells in culture are contained in your blood platelets.

Growing Stem Cells

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

The cells are isolated in the lab and grown to higher numbers over the next 10-18 days.

How many stem cells do you need to do the procedure?

That depends on the procedure, but usually between 1 million and tens of millions.

What happens if you grow more than you need for the procedure?

We can save the extra cells in cryopreservation (cold storage).

How often do you have problems with not growing enough stem cells?

In a few percent of our patients this is an issue. If this happens, we may need to repeat the draw and the culture procedure. We also have developed strategies to reduce the likelihood that this happens again. There are certain patients we have identified who are at rrisk of this happening, they are:
-Women who are near menopause, ages 45-55
-Patients on certain drugs
-Patients who are ill or who have low activity levels
If you are in one of these risk categories, you will be offered a shared risk program. In this way, we can share the financial risk of not getting enough cells and perform additional draws for one set fee. You may also wish not to pursue this type of autologous procedure.

Freezing Stem Cells

How long can the stem cells be frozen?

Indefinitely

What do you use to freeze the stem cells?

The cells are prepared with DMSO and then slowly frozen in a series of solid state freezers down to -150 degrees Celsius. We use only dry phase storage (no liquid nitrogen), as recent studies have shown that it may be possible to transmit viruses in samples stored in liquid nitrogen. While this dry phase storage technology is dramatically more expensive and well above the standards followed by 99% of the current cell storage facilities, we believe the added measure of safety is important.

The Procedure

How painful is the procedure for implanting stem cells?

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

How do you know where to place the cells?

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

Post-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.

Will I need a second procedure?

Many of our patients will require a second or even third procedure. Our usual protocol involves 2-3 injection cycles.

Will you have to draw more cells if I need a second or subsequent procedure?

About 7 times out of 10 we will have enough cells saved from the first procedure to use on the second or subsequent procedure.

Should I take specific supplements after my procedure?

Yes, we have supplements we recommend or if you would rather take another brand, we have a list of important joint health supplements that you should take.

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 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.

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.

Is there anything else that you need me to do to 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

Insurance Coverage

Why doesn’t insurance cover this procedure?

The procedure is too new to be covered yet by insurance.

How much does this procedure cost?

The cash price for most Regenexx procedures is $7,000-$8,500 depending on what is being treated. That includes a marrow draw, blood draw, lab expansion of the cells, pre-injection, re-injection of cells and post injection(s). If we believe its best to treat your condition with a series of shots, this covers the first series (which can be up to three shots). This total is paid at time of service over time, meaning the patient pays for the bone marrow draw and culture expansion separately and then pays for the re-inections as they happen. If you have enough stem cells left over and need additional procedures, that runs an additional $3,500.

Will insurance cover the initial evaluation?

If we are on your insurance network we will bill your carrier. If not, then there will be a $250-$315 (depending on complication level) consultation fee for the initial face to face consult.

Getting a Review of Films with a Clinic Doctor

How can the doctor determine if I’m a candidate for the procedure?

The doctor can look at your films, history, and speak to you on the phone about if 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 see 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.
Realize that we currently place about 1/4 of the patients we see as GOOD candidates for the procedure, 1/2 as FAIR candidates, and 1/4 as POOR candidates. For more info on this, see http://www.regenexx.com/2009/06/the-integrity-of-prospectively-grading-patients/

How much will the review of films cost?

$200 for 20-30 minutes with the doctor. If you are determined to be a qualified candidate and you proceed to the procedure, this fee will be applied to the cost of the treatment.

How can the doctor look at my images/films?

The doctors perfer CD’s and not hard copies of actual films. These days, most imaging centers can easily and inexpensively burn a CD with the digital copies of your films. These can be sent to Regenerative Sciences, Inc at 403 Summit Blvd. Suite 201, Broomfield, CO 80020.

How do I set up a review of my films?

Please send an email to scheduling@centenoschultzclinic.com

Complications

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.  Through December 2011, the full text of the paper is available at this link.

General

Why don’t other doctors do this yet?

We are training other doctors in the technique. Like any new technique, the medical community takes some time to adopt the procedure. For more info on the International Cellular Medicine Society (ICMS), see http://www.cellmedicinesociety.org/

How do the stem cells know what type of tissue to grow into?

Based on the research in this area, local cell type, pressure, and chemical environment also help the cells to determine which type of cells will be formed.

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.

Can an adult stem cell transplant cause cancer?

The basic science on adult stem cells shows that if the cells are kept in culture for short periods, that 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 the University of Colorado genetics lab to clear each patient’s cells before they are used in treatment as an additional safety check.

More on Cancer Risk:

During a recent webinar, an educated participant asked some very good questions. I thought his questions would make great FAQ’s, so I posted them here:

What is the occurrence of tumor growth in patients undergoing regenexx?

We have monitored approximately 60 patients with ultra high field 3.0 T MRI for up to approaching 3 years without any evidence of tumor growth at the re-implant sites. 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.

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

Approximately 3+ years.

Given the novelty of your technique, is there any foreseeable risks of cancer long term in the patient? A recent summary by D. Prockop seems to suggest it is of concern in treatments.

We can’t rule out any long-term risk, as long-term data isn’t available (more than 5 years). However, the author mentioned (Prockop), has published showing no risk of cancer when cells are cultured for short periods (6-8 weeks). The Regenexx procedure generally only cultures cells for less than 4 weeks. This is consistent with other authors who have shown that cells cultured for limited periods show no detectable risk of malignant transformation. Meaning, cells grown for acceptable periods that are consistent with what happens in the body are more likely to be safe, while cells grown artificially in any manner (artificial growth factors, abnormally long time periods, with genes added or deleted) likely present a much greater risk. The ICMS/ASCTA have a great video on these issues. In addition, stem cell cancer models typically use a 3 month window to detect tumor formation.

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 the appr0ximately 60 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”.

Do mesenchymal cells stay localized to the injection site…is there any risk of them traveling throughout the body?

MSC’s do stay local at 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.

Medications

Why can’t I be on certain medications during the procedure?

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

Are there any medications or supplements I can take that will increase the activity or healing abilities of my stem cells?

None that we know for sure right now, however we generally recommend good nutrition and basic joint supplements such as collagen, glucosamine, and chondrotin.

Stem Cell Lab

What type of lab do you use to grow the stem cells?

Our lab is an extension of our medical practice. Our lab uses the guidelines set bu the International Cellular medicine Society (ICMS), click here for more info.

Who checks to make sure that you are following these guidelines?

We use Reglera, a nationally known lab accreditation company. We periodically audit the lab and make any changes recommended by Reglera.

Do you perform checks on the cells?

Yes, we send random samples out for contamination to Quest Diagnostics. The cells are also under periodic microscopic surveillance. In addition, we use periodic flow cytometry to check on cell phenotype. We also work with the University of Colorado genetics lab to clear each patient’s cells before they are used in treatment as an additional safety check.

Are you licensed by the state?

Colorado has no tissue bank licensure. However, recently New York state asserted that we needed a New York tissue banking license to treat NY patients. While we disagreed with the general assertion that NY can regulate medical activities in Colorado, we did apply for such a license and did receive a provision license, which can be seen here.