FDA Clears Cord Blood Therapy for Long COVID Fatigue Relief
The Food and Drug Administration (FDA) has granted clearance for an expanded access program for RegeneCyte, a hematopoietic progenitor cell (HPC) therapy developed by StemCyte Inc. This therapy is intended for patients experiencing severe effects from post-acute sequelae of SARS-CoV-2, commonly known as long COVID.
A New Approach to Long COVID
According to StemCyte CEO Tong-Young Lee, PhD, the FDA’s clearance “is a significant validation of the safety and therapeutic potential of RegeneCyte.” The company already holds a Regenerative Medicine Advanced Therapy (RMAT) designation and views this program as a way to help patients while continuing clinical development and navigating the regulatory process.
RegeneCyte works by restoring blood and immune function, and is currently used for patients with inherited or acquired blood disorders, or those whose hematopoietic system has been damaged by treatments. A phase 2a clinical trial (NCT05682560) assessed its safety and effectiveness in treating long COVID symptoms.
Promising Results from a Phase 2a Trial
The trial, conducted in the US with 30 participants, involved a randomized, single-blind, placebo-controlled design. Twenty-two participants received the HPC cord blood treatment, while ten received a placebo. Fatigue severity was measured using the Chalder Fatigue Questionnaire (CFQ-11). Results indicated a significant improvement in fatigue symptoms, with 85% of those treated with RegeneCyte reporting complete relief, compared to only 20% in the placebo group.
The study also met its primary safety endpoint, with mild, self-resolving treatment-emergent adverse events (TEAEs) occurring in 10% of the HPC group and 20% of the placebo group. Improvements were also seen in patients’ overall perception of their fatigue symptoms, as measured by the PGI-S scale. While cognitive function, assessed using the MoCA, showed a slight improvement, it was not statistically significant.
Understanding the Scope of Long COVID
Long COVID is a chronic condition triggered by the virus that causes COVID-19. It is characterized by a wide range of symptoms – over 200 have been identified – that can persist, worsen, or reappear over time. Common symptoms include extreme tiredness, brain fog, problems with taste or smell, sleep issues, shortness of breath, and digestive problems.
The condition can also contribute to or exacerbate other health issues, such as migraine, lung disease, autoimmune disease, and chronic kidney disease. Long COVID has been linked to diagnoses including heart disease, mood disorders, stroke, and diabetes.
What’s Next?
StemCyte plans to accelerate the development of RegeneCyte and is in discussions with the FDA regarding the next phase of clinical trials. It is possible that larger, more comprehensive studies will be initiated to further evaluate the therapy’s efficacy and safety. If subsequent trials continue to demonstrate positive results, RegeneCyte could potentially become a new treatment option for individuals struggling with long COVID.
Frequently Asked Questions
What is RegeneCyte?
RegeneCyte is an allogeneic cord blood-derived hematopoietic progenitor cell therapy used to restore blood and immune function.
What were the key findings of the phase 2a trial?
The trial showed that 85% of patients treated with RegeneCyte reported complete relief from fatigue, compared to 20% in the placebo group. The therapy also demonstrated a favorable safety profile.
What are the common symptoms of long COVID?
Common symptoms include extreme tiredness, brain fog, problems with taste or smell, sleep problems, shortness of breath, cough, headache, a fast or irregular heartbeat, and digestive problems.
As research into long COVID continues, what role do you think innovative therapies like RegeneCyte might play in improving the lives of those affected?