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Unproven Stem Cell Therapy Gets OK for Testing in Coronavirus Patients
The treatment, which has been promoted by President Trump’s personal lawyer, Rudy Giuliani, will begin early-stage clinical trials.
The therapy, which will be tested in up to 86 patients, involves using stem cells from the placenta — known as “natural killer” cells.Credit...Wojtek Radwanski/Agence France-Presse — Getty Images
By Katie Thomas
April 2, 2020, 9:01 a.m. ET
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 Trump’s personal lawyer. Mr. 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 H.I.V. antivirals, are being tested in patients around the world.
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 F.D.A. approval for Covid-19 cell therapy.” The agency’s 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 drug’s safety and effectiveness has been upended by Mr. 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 F.D.A. 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.
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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, Celularity’s founder and chief executive, said in an interview Wednesday.
“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.”
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.
Dr. 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 to 60 days after the first patients receive their dose. If this study is successful, Dr. Hariri said, the company would move to a placebo-controlled study that would evaluate the drug’s 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, Mr. Giuliani has become an early booster, interviewing Dr. Hariri on a podcast published on his website Saturday , and praising the treatment on Twitter, saying, “this therapy has real potential.” In a tweet on Saturday, he added, “Let’s hope F.D.A. 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 Mr. 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 Mr. Trump has supported.
Dr. Hariri said that he has known Mr. 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 Mr. Giuliani, and that Mr. Giuliani is not representing him in any way, either paid or unpaid. “I don’t have anything to do with what the mayor tweets or whatnot, and I don’t agree or disagree with anything,” he said.
Dr. Hariri said the company would follow the established process for testing whether a drug works. “We have waited for the F.D.A. to complete their review, which they did in a heroic and quick fashion,” he said.
On Wednesday evening — the same day the F.D.A. approved his trial — Dr. Hariri praised the appearance by the agency’s 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.
Answers to Your Frequently Asked Questions
Updated March 24, 2020
How does coronavirus spread?
It seems to spread very easily from person to person, especially in homes, hospitals and other confined spaces. The pathogen can be carried on tiny respiratory droplets that fall as they are coughed or sneezed out. It may also be transmitted when we touch a contaminated surface and then touch our face.
Is there a vaccine yet?
No. The first testing in humans of an experimental vaccine began in mid-March. Such rapid development of a potential vaccine is unprecedented, but even if it is proved safe and effective, it probably will not be available for 12 to18 months.
What makes this outbreak so different?
Unlike the flu, there is no known treatment or vaccine, and little is known about this particular virus so far. It seems to be more lethal than the flu, but the numbers are still uncertain. And it hits the elderly and those with underlying conditions — not just those with respiratory diseases — particularly hard.
What should I do if I feel sick?
If you’ve been exposed to the coronavirus or think you have, and have a fever or symptoms like a cough or difficulty breathing, call a doctor. They should give you advice on whether you should be tested, how to get tested, and how to seek medical treatment without potentially infecting or exposing others.
How do I get tested?
If you’re sick and you think you’ve been exposed to the new coronavirus, the C.D.C. recommends that you call your healthcare provider and explain your symptoms and fears. They will decide if you need to be tested. Keep in mind that there’s a chance — because of a lack of testing kits or because you’re asymptomatic, for instance — you won’t be able to get tested.
What if somebody in my family gets sick?
If the family member doesn’t need hospitalization and can be cared for at home, you should help him or her with basic needs and monitor the symptoms, while also keeping as much distance as possible, according to guidelines issued by the C.D.C. If there’s space, the sick family member should stay in a separate room and use a separate bathroom. If masks are available, both the sick person and the caregiver should wear them when the caregiver enters the room. Make sure not to share any dishes or other household items and to regularly clean surfaces like counters, doorknobs, toilets and tables. Don’t forget to wash your hands frequently.
Should I wear a mask?
Experts are divided on how much protection a regular surgical mask, or even a scarf, can provide for people who aren’t yet sick. The W.H.O. and C.D.C. say that unless you’re already sick, or caring for someone who is, wearing a face mask isn’t necessary. The New York Times and other news outlets have been reporting that the wearing of face masks may not help healthy people, noting that while masks can help prevent the spread of a virus if you are infected, most surgical masks are too loose to prevent inhalation of the virus and the more effective N95 masks, because of shortages at health centers worldwide, should be used only by medical personnel. But researchers are also finding that there are more cases of asymptomatic transmission than were known early on in the pandemic. And a few experts say that masks could offer some protection in crowded places where it is not possible to stay 6 feet away from other people. Masks don’t replace hand-washing and social distancing.
Should I stock up on groceries?
Plan two weeks of meals if possible. But people should not hoard food or supplies. Despite the empty shelves, the supply chain remains strong. And remember to wipe the handle of the grocery cart with a disinfecting wipe and wash your hands as soon as you get home.
Can I go to the park?