Celltex Therapeutics Receives Another FDA Approval: Phase II Clinical Trial Using Mesenchymal Stem Cells (MSCs) as a Prophylactic Against COVID-19
HOUSTON: Celltex, a Houston, Texas-based biotechnology company, has announced that it has received approval from the U.S. Food and Drug Administration (FDA) to proceed with the Company’s Investigational New Drug application (IND 22055) to investigate the Prophylactic Efficacy of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) Against Coronavirus Disease 2019 (COVID-19).
“The FDA’s approval of our IND is not only a critical milestone for Celltex, but also for everyone who has been affected by COVID-19. Throughout the entire pandemic, MSCs have shown promise for combatting symptoms and complications associated with COVID-19, and as the nation’s leading commercial MSC banking and technology company, Celltex has the unique ability to transition these initial findings into a clinical trial. I am optimistic that our findings will result in favorable outcomes that will improve lives today and for generations to come,” says David G. Eller, Celltex Chairman and Chief Executive Officer.
Trial Design
This is a Phase 2 multi-center, randomized, double-blind, placebo-controlled study that will evaluate the safety and prophylactic efficacy of AdMSCs against COVID-19. Celltex will enroll 200 patients in the study (https://www.clinicaltrials.gov/ct2/show/NCT04428801) who have never been infected by COVID-19. One hundred patients will receive intravenous infusions of autologous AdMSCs while 100 will receive placebo treatments. The primary objective of the study is to evaluate overall safety of AdMSCs, and the secondary objective is to demonstrate the efficacy of AdMSCs as a prophylactic medicine for those at a high risk of contracting the virus.
