StemCyte has announced that the US Food and Drug Administration (FDA) has cleared an Expanded Access (EA) programme for RegeneCyte, its FDA-licensed Hematopoietic Progenitor Cell (HPC) therapy, for patients suffering from Long covid. The approval allows eligible patients to receive the therapy while the company continues its pivotal clinical development.

The FDA clearance follows encouraging results from StemCyte’s Phase IIa clinical trials, where 85 percent of Long covid patients treated with RegeneCyte experienced statistically significant improvement in chronic fatigue, compared to 20 percent in the placebo group. The Expanded Access pathway provides an option for patients who are severely affected but do not meet enrollment criteria for ongoing Phase III multi-centre studies.

According to StemCyte, the programme is designed to support patients with serious or life-threatening Post-Acute Sequelae of SARS-CoV-2 (PASC) who have exhausted available standard treatments. The company will work directly with treating physicians to determine patient eligibility and facilitate access under the FDA’s compassionate use framework.

Dr. Tong-Young Lee, CEO of StemCyte, said, “The FDA’s clearance validates the safety profile and therapeutic potential of RegeneCyte, our cord blood-derived HPC product. With our Regenerative Medicine Advanced Therapy (RMAT) designation already in place, this programme helps bridge unmet patient needs as we advance through late-stage clinical development.”

StemCyte highlighted that RegeneCyte is currently the only FDA-licensed cord blood product being evaluated in US clinical trials for Long covid. The Expanded Access clearance also underscores the growing role of newborn stem cell preservation in advancing regenerative medicine, particularly for conditions previously considered difficult to treat.

The initiative further reinforces StemCyte’s evolution from a global cord blood bank to a regenerative cell therapy company focused on delivering innovative treatments for complex diseases such as Long covid.