Are you one of the millions struggling with the lingering effects of Long COVID?
Do you feel like you’ve tried everything with no relief?
A groundbreaking development from StemCyte offers a new ray of hope.
The U.S. Food and Drug Administration (FDA) has just cleared an Expanded Access Program for RegeneCyte®, a cord blood-derived stem cell therapy. This decision opens a new door for patients suffering from the debilitating symptoms of Long COVID, particularly chronic fatigue.
The Science Behind RegeneCyte®
RegeneCyte® is a hematopoietic progenitor cell (HPC) therapy. These cells are sourced from umbilical cord blood and have the remarkable ability to rebuild the body’s blood and immune systems. For years, cord blood stem cells have been used to treat over 80 different diseases, including cancers and blood disorders .
Now, this regenerative power is being aimed at Long COVID. StemCyte’s research shows that RegeneCyte® can help resolve the persistent inflammation and immune dysregulation that many Long COVID patients experience.
Promising Clinical Trial Results
The FDA’s decision was based on compelling results from StemCyte’s Phase IIa clinical trials. The data showed a significant difference between patients who received the treatment and those who did not.
| Group | Chronic Fatigue Resolution |
| RegeneCyte® | 85% |
| Placebo | 20% |
These results highlight the therapeutic potential of RegeneCyte® for one of the most common and disruptive symptoms of Long COVID.
What is the Expanded Access Program?
The Expanded Access Program, also known as ‘compassionate use,’ provides a pathway for patients with serious or life-threatening conditions to access investigational therapies outside of a clinical trial .
This program is for individuals who have exhausted all other treatment options.
This is a critical step forward. It means that eligible patients who are severely affected by Long COVID but do not qualify for the ongoing Phase III trials can now get access to RegeneCyte®.
The Scale of the Long COVID Problem
Long COVID, or Post-Acute Sequelae of SARS-CoV-2 (PASC), affects a significant portion of people who contract the virus.
Current estimates suggest that up to 30% of individuals who have had COVID-19 experience lingering symptoms. In the United States alone, this translates to tens of millions of people.
Common symptoms include:
•Chronic fatigue
•Brain fog
•Shortness of breath
•Heart palpitations
•Muscle and joint pain
For many, these symptoms are not just a nuisance; they are life-altering. The economic and personal impact is immense, with many unable to return to work or their daily activities.
A New Era for Regenerative Medicine
StemCyte’s achievement marks a significant milestone in the field of regenerative medicine. It demonstrates how preserved newborn stem cells can be transformed into therapies for conditions that were previously considered untreatable.
“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.”
This development also highlights the importance of cord blood banking. What was once considered medical waste is now a valuable source of life-saving cells.
How to Access the Program
If you or a loved one is suffering from severe Long COVID and have exhausted other treatment options, this program may be an option. Access is facilitated through a treating physician.
StemCyte will work directly with doctors to manage access under the FDA’s compassionate use framework. This ensures that the treatment is administered safely and to the patients who need it most.
Looking Ahead
The journey to find a definitive cure for Long COVID is ongoing. However, the clearance of StemCyte’s Expanded Access Program for RegeneCyte® is a major step in the right direction. It offers immediate hope for those suffering the most and paves the way for future advancements in cell therapy.
This breakthrough provides a tangible option for patients and a renewed sense of optimism in the fight against Long COVID.
References
[1] ViaCord. “Current Uses of Cord Blood.”
[3] CDC. “Tracking Long COVID.”
