Therapeutic Solutions International announced today the launching of a double-blind, randomized, placebo controlled, multi-center, multi-nation, clinical trial of 128 patients with COVID-19 associated lung failure.
The study will be comprised of two groups, JadiCell™ treatment group and control group. The primary endpoint of the study is comparing the proportion of patients alive and free of respiratory failure at Day 60 after treatment with JadiCells as compared to placebo.
The Company has licensed the issued patent covering composition of matter for JadiCell and FDA Right of Reference1,2, has identified and filed patents on novel mechanisms of action of JadiCell related to lung preservation and regeneration3,4,5, and acquired the FDA cleared IND and associated data package, which was the basis for Phase III clearance6, and has contracted Biorasi, a global, full-service CRO, to launch and run the clinical trial.
"Cell therapy is one of the most promising and demanding forms of medical intervention," said Chris O’Brien, CEO of Biorasi. "In contrast to traditional medicines, products such as JadiCell are living therapeutics, which require a very detail-oriented approach to their administration as well as patient follow-up. We are honored to partner with TSOI for this landmark clinical trial."
In previous studies the Company has demonstrated the superior activity of JadiCell to other types of stem cells including bone marrow, adipose, cord blood, and placenta. Furthermore, the JadiCell was shown to be 100% effective in saving the lives of COVID-19 patients under the age of 85 in a double-blind, randomized, placebo controlled clinical trial with patients in the ICU on a ventilator. In patients over the age of 85 the survival rate was 91%7.
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