US Stem Cell Inc (USRM)

[4toSchool]

US STEM CELL and the FDA.

One case frequently referenced is the FDAs legal action against Regenerative Sciences, LLC. Information can be found here: D.C. Circuit Rules That FDA Can Regulate Autologous Stem Cells

IMPORTANT FACTUAL DIFERENCES BETWEEN USRM and REGENERATIVE:

1. Regenerative used a mixture of three types of human tissues and antibiotics, USRM uses only stem cells, no mixture
2. Regenerative cultured the stem cells. USRM only puts back the stem cells that they removed.
3. Regenerative didn't complete the procedure in a same-day visit like does USRM
4. Regenerative lost their case but are still actively in business

Regenerative is a Colorado company that owns a medical technique known as the Regenexx Procedure, which for the purposes of this case we understand is limited to a non-surgical procedure by which physicians take bone marrow and blood samples from a patient, culture the stem cells, mix the cultured cells with doxycycline, and inject the stem cell mixture back into the same patient in order to treat joint, muscle, tendon, or bone pain. This procedure is exclusively licensed for use by a Colorado clinic where its inventors practice.

Note: Regenerative mixed bone marrow, blood, cultured stem cells and doxycycline (antibiotic). This product mixture is materially different than USRM’s adipose stem cell, which isn't a mixture, as a patient's own stem cells are exclusively what's injected into their body.

The D.C. Circuit upheld the district court’s decision, frequently relying on long-standing principles of food and drug law. The court first found that the stem cell mixture met the definition of drug contained in the FDCA as it was “an article derived mainly from human tissue intended to treat orthopedic diseases and to affect musculoskeletal function.” Slip Op. at 6. In addition, and perhaps of more consequence, the court disagreed with Regenerative’s argument that FDA was interfering with the practice of medicine by preventing physicians from performing autologous stem cell procedures. The D.C. Circuit described this argument as “wide of the mark,” clarifying that FDA was seeking to regulate the stem cell mixture and not the procedure itself. Id. at 7.

So, will the Federal Court see the difference between Regenerative's mixture and USRM's sole tissue? Will the Court see that USRM is a same-day procedure? And that these facts should deem the procedures taught nad performed are under a physicians right to practice medicine. I hope so.

Interesting to note that Regenerative, having lost the case, is still actively in business. Here is a note appearing on their website to explain their business

Note to Reporters: The Regenexx procedures currently being offered in the US are 1271.15(b) compliant (same surgical procedure) and not considered a 351 drug by FDA. The only Regenexx procedure considered a drug by FDA was the Regenexx-C procedure, which has not been performed in the U.S. since 2010. For more information on the medical practice and its mission, click here.

In conclusion, if USRM loses to the FDA, there is a strong precedent that USRM could remain actively engaged in Stem Cell research development and treatment.