BALDWIN PARK, Calif., Jan. 26, 2026 /PRNewswire/ — 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,” said Dr. Tong-Young Lee, CEO of StemCyte. “With our RMAT (Regenerative Medicine Advanced Therapy) 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.”
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
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SOURCE StemCyte
