Understand the Sources of Stem Cell Treatments and Don’t Fall for False Promises.

FDA-approved Stem Cell Treatments

Not all stem cell treatments are the same!

Every day there seems to be a new ad to attend a seminar on donor “stem cell” treatments that claim to cure a variety of orthopedic and other medical conditions. But when you investigate the research on the type of cells they are using, many of these claims are overwhelmingly and alarmingly false. Before you fall for these aggressive sales tactics, be sure to understand what this product is and what it is not.

There are essentially two places to obtain stem cells for regenerative treatments: your own body and donor cells. Stem cells can be obtained from your own bone marrow, usually from the pelvic bone, or from your adipose tissue (fat cells). Stem cell “products” are made from donated amniotic fluid or cord blood from live births.

Based on research from leaders in the field of regenerative medicine, including those who have pioneered the procedures, the amniotic and cord blood “stem cell” treatments that come from vials “off the shelf” may contain some growth factors, but they do not appear to contain viable, living stem cells.

These types of stem cell treatments are comprised of highly-manipulated dead tissue that was harvested in a hospital delivery room, processed and transported to the treatment facility. It is important to understand that cryopreserved (dehydrated) amniotic products do not contain live stem cells.

For a stem cell treatment to work, the cells must be live and able to function.

Read a study from the Interventional Orthopedics Foundation (IOF) here:

These off the shelf amniotic and umbilical/cord blood treatments are being heavily marketed by some who do not even specialize in orthopedics and describe the treatment with these dead tissues as stem cell therapy. What is worse, many of these practices give prospective patients false confidence by posting unrelated stem cell research on their websites. There indeed have been mountains of research that has been done on amniotic and cord blood stem cell transplantations. But these were performed in highly controlled lab environment – very different from a clinic injecting “stem cells” into a patient from a vial of dead tissues off the shelf.

Some also claim that they are approved by the FDA, which is very misleading. For there to be living stem cells in the processed tissue that was donated, and then to be used in a different patient for orthopedic applications (knee arthritis, etc.), that stem cell product would have to go through extensive FDA tests and trials to earn designation as a cellular drug. This approval does not exist. At this point in the United States, the only FDA approved stem cell-based products consist of blood forming stem cells for use in treating blood cancers.

Know Your Facts

What does it mean to be FDA-approved?
There are essentially two tracks through FDA-approvals for donor tissues: the simple 361-tissue registration, and the more complex 351-cell drug designation. These two are completely different. All the off-the-shelf orthopedic amniotic and cord blood products in the U.S. market today use the 361-tissue registration. However, the FDA clearly categorizes any “stem cell” product or therapy that uses live cells from a donor be categorized as a drug using the 351-cell drug designation. This would also require them to complete 5-10 years of clinical trials and data. These clinics are avoiding the rigorous 351-cell drug designation by giving their patients dead tissue. There are currently no FDA-approved amniotic or cord blood stem cell products intended for use in orthopedic applications in the United States.

What are stem cells?
Stem cells are unspecialized cells with self-renewal potential that can differentiate into various adult cell types. Stem cells are present in everyone at all ages and are part of the body’s natural healing process. They are more concentrated in some areas of the body than others. Research has shown that mesenchymal stem cells (MSCs), have the best potential in orthopedic applications to reduce inflammation, self-replicate and may help regenerate soft tissue, bone and muscles. Stem cells must be alive in order to work.

What is bone marrow concentrate?
The best place to find MSCs is in your own bone marrow. At Regen Orthopedics and other reputable providers of regenerative medicine, we utilize a patient’s own adult stem cells, not stem cell “products.” This involves a relatively quick procedure in which a patient is put under light sedation and bone marrow is obtained from the pelvic bone through needle aspiration. The tissues are then immediately placed in a centrifuge to separate and concentrate the growth factors. This bone marrow concentrate (BMC) also contains many other healing and growth factors. The BMC is then carefully injected under ultrasound guidance by a medical doctor. While results may vary, most patients find pain relief that can last up to eight years.

Who is best qualified to provide these treatments?
An orthopedic specialist is best suited to perform the procedure to ensure the stem cells are injected properly into the affected joints. They are also trained to understand the complexities around how different tissue types require a different concentration of injectable cells. Our treatments are provided by medical doctors who specialize in orthopedics and use precise imaging and ultrasound guidance during the procedure.

All leaders in the field of orthopedics and regenerative medicine who are offering patients this service, are using bone marrow concentrate (BMC) as the method of choice. We are not aware of any of the leaders in regenerative medicine that are offering amniotic/cord blood products who are not also a consultant for a company that processes these products – they have a vested interest. So, the question is, if using your own stem cells is the best method, why are some doctors using amniotic/cord blood products? The answer is that using these off the shelf vials of “stem cells” is an easier method for the doctor and easier way to generate revenue. Regenerative medicine using BMC is better, but a more challenging procedure for the doctor. Most doctors do not have the training or skill to do the BMC procedure.

How We Are Different
At Regen Orthopedics, our patients receive care from a highly trained medical doctor who specializes in both surgical and nonsurgical orthopedic treatments and research. The procedure utilizes the patient’s own adult stem cells and growth factors from bone marrow. This bone marrow concentrate (BMC) is taken from the patient’s pelvic bone and then injected into that same patient’s injured area. In order to be FDA compliant, this procedure must be done in the same building, in the same day. Cord blood donations are taken in a hospital setting and the cells obtained are highly manipulated and frozen, which causes cell death. The only way the cells could survive would be in a highly controlled lab environment. Much of the research on amniotic stem cells was conducted in a lab and that, of course, affects the study results.

Are stem cell treatments right for everyone?
No. There are several health factors that may disqualify you from safely receiving a stem cell treatment. Our doctors carefully screen all patients to determine if they are proper candidates for stem cell treatment. To find out if you are a candidate, call 844-STM-CELL (844-786-2355) to schedule a consultation. Regen Orthopedics is in Beachwood, Ohio. For more information, visit www.regenorthopedics.com.

Please see 10 Questions You Should Ask when selecting a provider of regenerative medicine treatments for more information on this topic.


For more information or to schedule a consultation with Dr. Gobezie to review what’s causing you pain, call 844-786-2355. Our office is located at 3755 Orange Place in Beachwood, Ohio. Learn more about Dr. Gobezie here.