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Regenexx procedures are FDA compliant

Regenexx Stem Cell and PRP Procedures Remain Only FDA Compliant Treatments

In late summer 2020, the FDA issued a Consumer Alert on regenerative medicine products including stem cells and exosomes. At first glance, it may seem like a warning against the kind of procedures Regenexx Pittsburgh offers. But rest assured, our procedures are not only fully legal, but also proven to work. Here’s why.

What’s Not Okay

The products listed in the alert were not only unapproved and illegal, but are also proven to be ineffective in treatment. This list included exosomes, adipose stromal vascular fraction, umbilical cord blood, Wharton’s jelly, and amniotic fluid.

No stem cells in umbilical cord blood

Shown are 6 well seeded plated of middle-aged bone marrow, compared with Liveyon PURE umbilical cord blood. Purple dots are counted as mesenchymal stem colonies. Note numerous stem cells in the bone marrow sample and NONE in the umbilical cord blood sample.

As you can see in the diagram above, there are no live stem cells in umbilical cord blood, whereas autologous bone marrow is rich with them.


Why You Don’t Need to Worry with Regenexx Pittsburgh

The good news is, Regenexx Pittsburgh only uses your own live stem cells in our procedures. As none of the illegal products contain live stem cells, we do not use them — making our offering completely legal and not requiring FDA regulation. It’s also important to note that the stem cells we use are autologous, meaning that the cells used in a patient procedure are derived from that same patient.

Hyaluronic Acid Not a Long Term Knee Osteoarthritis Treatment
Although Huge in the Wrinkle-Reducing Cosmetic World

Another autologous and FDA-compliant substance we occasionally utilize as a part of long term Osteoarthritis treatment, is hyaluronic acid. This is simply clear, gooey matter found naturally in human skin, connective tissues, and eyes. Consumer goods cosmetic companies  often advertise hyaluronic acid (sometimes called HA) for hydrating skin and reducing wrinkles. Although not a treatment in and of itself for knee or joint Osteoarthritis (its effects last only up to six months), it can help lubricate joints alongside stem cell injections,

Proven Results

Our procedures are not only completely legal, but also proven to work. Take a look at our registry, which tracks the success rate of our procedures using patient-reported outcomes of long term joint function, pain, and overall improvement. We know our patients value getting back to the activities they love — whether that is walking, running, skiing, or high-level sports — and our procedures allow them to do just that. The registry above shows that over time, patients’ joint function only improves, pain only decreases, and overall joint improvement increases after undergoing one of our procedures.

To find out if these stem cell procedures are right for you or for more information, please get in touch with us.