Celltex Therapeutics gets FDA nod for Covid-19 stem cell clinical trial
Covid-19 stem cell clinical trial : Celltex Therapeutics has been given the clearance by the US Food and Drug Administration (FDA) to move ahead with a phase 2 clinical trial for investigating the efficacy of autologous adipose tissue-derived mesenchymal stem cells (AdMSCs) in the prevention of Covid-19.
In this connection, the Texas-based biotech company had been given approval by the FDA for its investigational new drug application (IND 22055).
The multi-center, randomized, double-blind, placebo-controlled coronavirus stem cell clinical trial that will assess the safety and prophylactic efficacy of AdMSCs against COVID-19 in 200 participants who were never been infected by the virus.
Celltex Therapeutics will subject 100 participants with intravenous infusions of autologous AdMSCs while the other 100 will be given placebo treatments. The primary objective of the phase 2 Covid-19 stem cell clinical trial is to evaluate overall safety of AdMSCs, while the secondary goal is to demonstrate the efficacy of AdMSCs as a prophylactic medicine for those at a high risk of contracting the novel coronavirus.
Commenting on the Covid-19 stem cell clinical trial, David G. Eller – Celltex Therapeutics Chairman and CEO, said: “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.”