Celltex Therapeutics gets FDA nod for Covid-19 stem cell clinical trial

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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.

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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.

Celltex Therapeutics gets FDA approval to move ahead with its phase 2 Covid-19 stem cell clinical trial

Celltex Therapeutics gets FDA approval to move ahead with its phase 2 Covid-19 stem cell clinical trial. Photo courtesy of Business Wire.

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.

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“I am optimistic that our findings will result in favorable outcomes that will improve lives today and for generations to come.”

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