Stem Cell Therapy Gets OK for Testing in Coronavirus Patients
Celularity will start testing patients with Covid-19, using stem cell therapy developed from human placentas.
The company has not yet tested this treatment on any patients with Covid-19. However, Rudy Giuliani spoke recently with the company founder, Dr. Hariri, and interviewed him. Indeed, there is no current treatment yet that is considered proven and effective.
Celularity has also promoted the news of its early-stage study for its therapy, known as Cynk-001. Their public relations message suggests it’s the “first F.D.A. approval for Covid-19 cell therapy.” The FDA has simply granted permission for Celularity to conduct this study on patients.
FDA gives green light
The FDA has modified their approval process in an effort to make experimental products and therapies available sooner for Covid-19 patients. They approved medications to be repurposed for use on patients with Covid-19 on an emergency basis without clinical trial data.
Celularity will test 86 patients with the therapy. They will administer infusions to these patients. “The objective here is preventative,” Dr. Hariri said. “If the timing of giving this can prevent those patients who have early disease from progressing to the more serious, life-threatening form, it could be a very, very useful tool.”
In fact, the process takes stem cells from the placenta after a live healthy birth. Both mother and child are healthy without any complications. The company has been using the healthy placentas to make stem cell therapies for cancer patients.
Furthermore, Dr. Hariri said the study will happen at academic medical centers around the country. He said initial results from the study can become possible about 30 to 60 days after the first patients receive their dose.
If this trial is successful, Dr. Hariri said, the company would progress to a placebo-controlled study that would evaluate the treatment’s efficacy against Covid-19.