Stem cell clinic to ‘vigorously defend’ US FDA lawsuit

By Melissa Fassbender

- Last updated on GMT

The US Department of Justice has filed a lawsuit to stop US Stem Cell Clinic from performing autologous stem cell procedures at the request of the US Food and Drug Administration (FDA).

US Stem Cell, Inc. (USRM) – a provider of “physician-based stem cell therapies and novel regenerative medicine solutions​” per its website – has subsequently announced​ its intent to “vigorously defend”​ the lawsuit.

The lawsuit seeks to stop USRM and related parties from performing a surgical procedure using stem cells from autologous adipose tissue.

Dr. Kristin Comella, chief science officer of US Stem Cell, told us in a statement:

“My entire career has been dedicated to studying and developing treatments utilizing the body’s own natural ability to heal, and I am devoted to helping others achieve optimal health through therapeutic procedures.

It is my life’s work to pioneer regenerative medicine and educate the public about its healing potential. I remain steadfast that no government agency should deprive individuals of their right to harness the cells that exist in their body.”

The company is not providing any additional comment at this time.

The Sunrise, FL-based company trains and certifies physicians on the administration of stem cell therapies and protocols. According to the company it has trained more than 700 physicians worldwide and is currently opening standalone and partners stem cell clinics, four in the US and “several” other across the globe.

USRM currently has two targeted stem cell products under development for the repair of cardiac tissue: MyoCellR and MyoCell SVF-1TM— both of which are slated to enter the next phase of clinical development.

As per the company’s website, it is currently seeking partners to develop and commercialize these products.

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