The Mission of Regenerex

The mission of Regenerex, LLC, is to make the facilitating cell platform technology (FCRx) widely available to treat many disorders with unmet need. The FCRx product eliminates the need for a perfectly matched donor, thereby allowing nearly any candidate for a stem cell transplant to receive the treatment. Hematopoietic stem cell transplantation (HSCT) has been used to successfully treat inherited metabolic enzyme disorders, red blood cell disorders (sickle cell disease and thalassemia), to induce tolerance to organ transplants and to treat autoimmune disorders such as type 1 diabetes, multiple sclerosis, rheumatoid arthritis and scleroderma."

The Formation of Regenerex

Regenerex, LLC, was incorporated in 2002 in Delaware. Regenerex is a biopharmaceutical company based in Louisville, Kentucky, for production of the company’s proprietary FCRx platform therapy. The hematopoietic stem cell-based immunological tolerance protocol is in the final stages of a successful FDA Phase II clinical trial in living donor kidney transplant recipients that has resulted in graft survival without the need for lifelong immunosuppression.

Worldwide Exclusive Partnership with Novartis

In 2013, Regenerex formed a worldwide exclusive partnership with Novartis to make the FCRx cellular product widely available. This collaboration reaffirms the Novartis commitment to transplantation. Beyond transplant, Regenerex’s novel platform potentially has curative potential for multiple diseases with unmet need and will be investigated in the rescue of serious genetic deficiencies such as inherited metabolic storage disorders and hemoglobinopathies. “As the field of biomedicine sits on the cusp of a new transformation, we are excited to announce this agreement which supports the Novartis leadership position in cell therapy,” said Dr. Timothy Wright, Global Head Development, Novartis Pharmaceuticals. “Thirty years ago, Novartis developed cyclosporin, which changed transplantation treatment paradigms and enabled countless lives to be saved. Now, this collaboration along with our internal cell therapy assets, has the potential to transform medicine once again through innovation.” As a result, potentially millions suffering from a number of disorders could benefit.

Collaboration with ICT (UofL's Institute for Cellular Therapeutics)

Regenerex has established a novel strategic public/private partnership with the University of Louisville’s Institute for Cellular Therapeutics to expedite translation of discoveries from bench to bedside. Corporate and university scientists work together to manufacture the FCRx product and study the mechanism of action of the facilitating cell’s functions in this unique translational research environment.


Dr. Suzanne T. Ildstad

Dr. Ildstad's Summary Biography