Rudy Giuliani pushes FDA to fast-track a stem cell therapy for Covid-19 – STAT

Rudy Giuliani, President Trump’s personal attorney, is urging the Food and Drug Administration to fast-track clinical trials of an experimental stem cell therapy in Covid-19 patients, prompting fears of political meddling in a scientific process meant to protect patients.

In recent days, Giuliani has used his Twitter account and podcast to tout the stem cell treatment being developed by a New Jersey biotech company, Celularity, despite scant evidence to date that its therapy will benefit Covid-19 patients.

The company is currently seeking permission to start a clinical trial for the treatment. Giuliani, for his part, has been critical of the FDA, accusing it of standing in the way of important treatments.

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“The general reputation of the FDA — and I don’t mean to be critical at a time like this — but it is very slow,” Giuliani said in an interview on his podcast with Bob Hariri, Celularity’s founder and CEO. “I have represented pharma companies and it was my observation that they took forever in situations where people are dying. Come on, let’s go. Let’s move.”

Later on Twitter, Giuliani said Celularity’s therapy, CYNK-001, has “real potential” and “trials need to be EXPEDITED.” In a response to a tweet from one of his followers, Giuliani replied, “Let’s hope FDA can recognize that their cumbersome process designed to keep us safer, if it is not altered dramatically in times
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