Therapy Areas: Respiratory
Therapeutic Solutions International Launches Phase III Clinical Trial for Treating COVID-19 Lung Damage Using its JadiCell Universal Donor Stem Cell Drug
2 May 2022 - - US-based immune modulation specialist Therapeutic Solutions International has launched a double-blind, randomized, placebo controlled, multi-center, multi-nation, clinical trial of 128 patients with COVID-19 associated lung failure, the company said.

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 Reference, has identified and filed patents on novel mechanisms of action of JadiCell related to lung preservation and regeneration, 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.

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%.

Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases.

The company's corporate website is www.therapeuticsolutionsint.com.

Biorasi is a customer-focused, full-service, contract research organization that delivers fast and flexible solutions across global clinical trials to maximize speed-to-market for its sponsors.

The company is a specialist in neurology, nephrology, dermatology, and the rare and urgent disease market.
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