Unproven Stem Cell Therapy Gets OK for Testing in Coronavirus Patients – The Indian Express

By: New York Times | Published: April 2, 2020 10:59:26 pm On Saturday, the FDA took the unusual step of approving those drugs to treat hospitalized patients with coronavirus on an emergency basis, even though no significant clinical trials have yet been done.

Written by Katie Thomas

An experimental stem cell therapy derived from human placentas will begin early testing in patients with the coronavirus, a New Jersey biotech company said Thursday.

The treatment, being developed by the company Celularity, has not yet been used on any patients with symptoms of COVID-19, but it has caught the attention of Rudy Giuliani, President Donald Trumps personal lawyer. Giuliani recently featured an interview with the company founder on his website and said on Twitter that the product has real potential, while also criticizing the Food and Drug Administration for not moving more quickly to approve potential remedies.

There is no proven treatment for the respiratory disease, but several experimental approaches, including old malaria drugs and HIV antivirals, are being tested in patients around the world.

READ | Video from Japan shows how COVID-19 is getting transmitted through a third route

Celularity has also enthusiastically publicized the news of its early-stage trial for its treatment, known as CYNK-001. In an email Wednesday to a reporter, its public relations firm described a development as the first FDA approval for COVID-19 cell therapy. The agencys decision, however, merely gives a green light for its product to be used in a clinical trial, not widely prescribed to patients.

In recent weeks, the established scientific process of evaluating a drugs safety and effectiveness has been upended by Trump, who has repeatedly promoted the potential of two long-used malaria drugs that have shown mainly anecdotal evidence of helping patients. On Saturday, the FDA took the unusual step of approving those drugs to treat hospitalized patients with coronavirus on an emergency basis, even though no significant clinical trials have yet been done.

The early trial by Celularity which will primarily evaluate safety, as well as an initial look at efficacy will test its therapy in up to 86 patients with symptoms. They will receive infusions of the cell therapy in the hopes it will prevent them from developing the more severe form of the disease, Dr. Robert Hariri, Celularitys founder and chief executive, said in an interview Wednesday.

The objective here is preventative, 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.

The therapy involves using stem cells from the placenta known as natural killer cells that help protect a developing fetus or newborn from viruses that have infected the mother. Celularity has been testing these cells in cancer patients.

Hariri said the trial, which would not include a placebo control group, will take place at academic medical centers around the country. He said the company expected to see initial results about 30-60 days after the first patients receive their dose. If this study is successful, Hariri said, the company would move to a placebo-controlled study that would evaluate the drugs efficacy against the disease.

At least one outside expert said the approach could present safety risks. Paul Knoepfler, a stem cell researcher at the University of California, Davis, said that patients with coronavirus can develop severe reactions where their immune systems go too far in attacking cells in their lungs, causing damaging inflammation. Other cell therapies tested in China are designed to dampen the immune response. He said one risk with the natural killer cells is they could go in the other direction, exacerbating respiratory problems by massive killing of the patients respiratory cells.

Despite the scant evidence, Giuliani has become an early booster, interviewing Hariri on a podcast published on his website Saturday and praising the treatment on Twitter, saying, this therapy has real potential. In a tweet Saturday, he added, Lets hope FDA can recognize that their cumbersome process designed to keep us safer, if it is not altered dramatically in times of great need, can result in unimaginable loss of human life.

Around the same time, Twitter deleted a post by Giuliani that it said violated its rules. The tweet, from March 27, made unfounded claims about the malaria drug hydroxychloroquine, one of the treatments that Trump has supported.

Hariri said that he has known Giuliani for years and that the appearance on his podcast was a friendly chat between people who know each other and who share a common interest in this particular response to this disease.

He said that he has no business relationship with Giuliani, and that Giuliani is not representing him in any way, either paid or unpaid.

I dont have anything to do with what the mayor tweets or whatnot, and I dont agree or disagree with anything, he said.

Hariri said the company would follow the established process for testing whether a drug works.

We have waited for the FDA to complete their review, which they did in a heroic and quick fashion, he said.

On Wednesday evening the same day the FDA approved his trial Hariri praised the appearance by the agencys commissioner, Dr. Stephen Hahn, on the conservative Fox News talk show The Ingraham Angle.

We are fortunate to have Dr. Hahn at the helm, he tweeted.

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Unproven Stem Cell Therapy Gets OK for Testing in Coronavirus Patients - The Indian Express