Subjects: TRI, FDA
StemCyte Announces FDA Approval of IND for a Phase II Clinical Trial to Treat Post-COVID Syndrome Using Umbilical Cord Blood Stem Cell Therapy
BALDWIN PARK, Calif., Aug. 29, 2022 /PRNewswire/ -- Southern California cord blood regenerative therapeutics company StemCyte is pleased to announce it has received approval from the U.S. Food and Drug Administration (FDA) for their Phase II clinical trial for Post-COVID Syndrome (or PCS) using umbilical cord blood stem cell therapy. PCS is also referred to as Long COVID and is characterized by lingering health effects or symptoms that are not explained by tests, which could last years.
PCS consists of sequelae in one-third of COVID-19 patients and could potentially be permanent. The U.S. government estimated that between 7.7 to 23 million people are suffering from PCS in the United States. In Asia, PCS prevalence reaches 51%. Symptoms of PCS include breathlessness, persistent cough, fatigue, pain, brain fog, anxiety, depression, palpitations, dizziness, weakness, and sleep problems. These symptoms have negative impacts on personal communication, daily activities, and social functioning. Some PCS sufferers even display severe disabilities. While a recent survey in the U.S. announced more than three-quarters of PCS patients did not feel sick enough to be hospitalized when infected with SARS-CoV-2, this impending health disaster is caused by a "silent killer" that seems determined to irreversibly destroy human health.
How this "silent killer" wreaks havoc on the body is still under investigation, as it appears SARS-CoV-2 viral infection is the current prospective mechanism leading to multiple organ damage. Moreover, this pathogenesis triggers long-term inflammation and autoimmunity. Therefore, although COVID-19 may be resolved in a patient, the remaining Long COVID symptoms become a chronic and systemic illness that leads to persistent PCS complications.
The prevention and treatment of COVID-19 is still challenged due to speedy mutations of SARS-CoV-2. Nevertheless, medical science has gradually identified keys to develop medicines to control infection. Hope remains in Pandora's box as the hope to cure PCS-mediated disability is yet under development. There have been a few candidates for potential treatment or cure examined in clinical trials, but almost all may just temporarily ameliorate a specific PCS symptom. Treatment with systemic and persistent efficacy will be the total solution to cure PCS. StemCyte's Phase II clinical trial aims to effectively treat PCS by infusing umbilical cord blood that is capable of anti-inflammation and tissue repair for long-term effect.
StemCyte is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular therapies. It has operations in the United States, Taiwan, and India. The company has cooperated with more than 350 medical transplant centers around the world, and has successfully assisted in the treatment of more than 2,200 patients using cord blood transplants. StemCyte considers umbilical cord blood banking its core competence, while actively pursuing new regenerative cell therapy indications, including spinal cord injury, Long COVID treatment, acute stroke, cerebral palsy and cancers. StemCyte's mission is to continue to develop its unique cord blood banking capabilities to achieve the goal of delivering lifesaving therapies to patients who suffered degenerative and other life-threatening diseases. Contact: [email protected] | www.stemcyte.com
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- The New York Times 2020-10-11 and 2022-05-18.
SOURCE StemCyte
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