StemCyte announced it has officially begun recruiting patients under a US Food and Drug Administration (FDA) approved Phase IIa human clinical trial in the United States.
| BALDWIN PARK, Calif., May 25, 2023 /PRNewswire/ -- StemCyte, Inc. announced it has officially begun recruiting patients under a US Food and Drug Administration (FDA) approved Phase IIa human clinical trial in the United States. This is the world’s first Phase II trial using umbilical cord blood cells to treat Post-COVID syndrome.
Cord Blood is a cell therapy biological drug that StemCyte is investigating to repair symptoms of Post-COVID Syndrome. According to StemCyte CEO Tong-Young Lee, this groundbreaking clinical trial design includes several advantages: firstly, it is the first FDA-approved Phase II clinical trial using umbilical cord blood cells to treat Post-COVID syndrome; secondly, it is also a clinical trial using umbilical cord blood cells to treat chronic fatigue which is related to anti-aging applications; thirdly, it is the FDA’s first approved design for administering multiple doses of umbilical cord blood cell therapy on one study subject. The research shows “Post-COVID” mainly manifests as three major symptoms including fatigue, brain fog, and muscle pain. In addition, acute respiratory distress syndrome (ARDS), chills, body pain, headache, joint pain, chest pain, coughing, and persistent loss of taste or smell can last for weeks or even months after recovery from acute illness without any effective treatment available yet. Cord blood is a cell therapy biological drug that StemCyte is investigating to repair fatigue and brain fog commonly seen in Post-COVID symptoms. It can not only provide long-term treatment but also help patients who have recovered from COVID-19 but still suffer from Post-COVID symptoms. Currently, Pfizer’s Paxlovid Phase III clinical trial and StemCyte’s HPC, Cord Blood complement each other in treating Post-COVID Syndrome. Since the launch of this project, StemCyte has received enthusiastic inquiries from COVID-19 patients across the United States. The official recruitment of patients for this trial provides encouragement to those suffering from Post-COVID without any effective treatments available yet. According to WHO statistics, since 2019 when the global outbreak began, more than 600 million people worldwide have been infected with COVID-19. About 10% of them, or approximately 60 million people, will develop persistent Post-COVID symptoms, which continues to increase. StemCyte International, Ltd. is a holding company of StemCyte US and StemCyte Taiwan. In 2022, StemCyte filed an Biologics License Application with the US FDA to license its HPC, Cord Blood product RegeneCyte® for patients suffering hematopoietic and immunologic disorders. Media contact: research@stemcyte.com
SOURCE StemCyte |
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