StemCyte Announces FDA Clearance of Expanded Access Program for REGENECYTE® to Address Unmet Need in Long COVID

StemCyte, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared an Expanded Access (EA) program for REGENECYTE®, the company’s FDA-licensed hematopoietic progenitor cell (HPC) therapy. This milestone enables eligible patients suffering from the debilitating effects of Post-Acute Sequelae of SARS-CoV-2 (Long COVID) to access the therapy while StemCyte continues its pivotal clinical research.

This EA program follows compelling data from StemCyte’s Phase IIa clinical trials. In those studies, 85% of Long COVID patients treated with REGENECYTE® experienced a statistically significant resolution of chronic fatigue, compared to just 20% in the placebo group. By authorizing Expanded Access, the FDA is providing a vital pathway for patients who are severely impacted by the syndrome but may not meet the specific enrollment criteria for ongoing Phase III multi-center trials.

“The FDA’s clearance of this program is a significant validation of the safety and therapeutic potential of REGENECYTE®, our HPC-cord blood product. With our RMAT designation already in place, this program allows us to bridge the gap for patients in need as we continue advancing REGENECYTE® through the clinical development and regulatory pathway.”

— Dr. Tong-Young Lee, CEO of StemCyte

The clearance of this program underscores the vital importance of newborn stem cell preservation. As regenerative medicine continues to evolve, REGENECYTE® serves as a primary example of how stored cord blood is being transformed into life-saving therapies for conditions previously thought untreatable, like Long COVID.

REGENECYTE® is currently the only FDA-licensed cord blood product being evaluated in U.S. clinical trials for Long COVID. This EA program further solidifies StemCyte’s transition from a premier cord blood bank to a leader in regenerative cell therapy.

Physician Inquiry and Patient Eligibility

The Expanded Access program is intended for patients with serious or life-threatening Long COVID symptoms who have exhausted standard treatment options. StemCyte will work directly with treating physicians to facilitate access under the FDA’s compassionate use framework.

About StemCyte

StemCyte is a global regenerative medicine company dedicated to developing innovative cell therapies. With a foundation in FDA-licensed cord blood products and an extensive global cell bank, StemCyte is advancing a robust pipeline targeting Long COVID, stroke, and spinal cord injury.

Forward-Looking Statements

This release contains forward-looking statements regarding the efficacy of REGENECYTE® and the implementation of the Expanded Access program. Actual results may differ based on clinical outcomes and regulatory requirements.

Media Contact

Michael S. Teufenkjian Marketing Manager mteufenkjian@stemcyte.com