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Real-World Safety, Efficacy Found for Fecal Transplants

Fecal microbiota transplantation (FMT) appears safe and effective as a treatment for most Clostridioides difficile infections as it is currently being administered, researchers say.

“We actually didn’t see any infections that were definitely transmissible via fecal transplant,” Colleen Kelly, MD, an associate professor of medicine at Brown University in Providence, Rhode Island, told Medscape Medical News.

The finding, published online today in the journal Gastroenterology could allay concerns about a treatment that has yet to gain full approval by the US Food and Drug Administration (FDA), despite successful clinical trials.

C diff infections are common and increasing in the United States, often can’t be cured with conventional treatments such as antibiotics, and can be deadly.

Transplanting fecal matter from a donor to the patient appears to work by restoring beneficial microorganisms to the patient’s gut. The procedure is also under investigation for a wide range of other ailments, from irritable bowel syndrome to mood disorders.

But much remains unknown. Researchers have counted a thousand bacterial species along with viruses, bacteriophages, archaea, and fungi in the human gut that interact in complex ways, not all of them beneficial.

The FDA has not enforced regulations that would prohibit the procedure, but in March, it warned about infections with enteropathogenic Escherichia coli (EPEC) and Shiga toxin-producing Escherichia coli (STEC) following fecal transplants.

As a result of these reports, and the theoretical risk of spreading SARS-CoV-2, OpenBiome, the largest stool bank in the United States, has suspended shipments except for emergency orders, and asked clinicians to quarantine any of its products they already have on hand.

In the meantime, long-term effects of the treatment have not been well documented. And clinical trials have excluded patients who might benefit, such as those who have been immunocompromised or have inflammatory bowel disease.

National Registry Follows Patients Outside Clinical Trials

To better understand how patients fare outside these trials, the American Gastroenterological Association Institute and other organizations developed a national registry, funded by a grant from the National Institute of Allergy and Infectious Diseases.

The current report summarizes results on 259 patients enrolled between December 5, 2017 and September 2, 2019 at 20 sites.

At baseline, 44% of these patients suffered moderate and 36% mild C diff infections. The duration of the diagnosis ranged from less than 1 week to 9 years, with a median duration of 20 weeks. They ranged from one to 15 episodes with a mean of 3.5.

Almost all had received vancomycin, and 62% had at least two courses. Forty percent had received metronidazole and 28% had received fidaxomicin.

Almost all participants received stool from an unknown donor, mostly from stool banks, with OpenBiome accounting for 67%. Eighty-five percent of the transplants were administered through colonoscopy and 6% by upper endoscopy.

Out of 222 patients who returned for a 1-month follow-up, 90% met the investigators’ definition of cure: resolution of diarrhea without need for further anti-C diff therapy. Ninety-eight percent received only one transplant. An intent to treat analysis produced a

Swedes indict surgeon for stem-cell windpipe transplants

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STOCKHOLM (AP) — A Swedish prosecutor on Tuesday indicted on charges of aggravated assault a surgeon believed to have made headlines in 2011 for carrying out the world’s the first stem-cell windpipe transplants, saying three people had laboratory-made tracheas implanted at Sweden’s leading hospital.

Although Mikael Bjork, director of Public Prosecution, didn’t name him, Swedish news agency TT said the surgeon was Dr. Paolo Macchiarini, who was once considered a pioneer in regenerative medicine, credited with creating the world’s first windpipe partially made from a patient’s own stem cells.


In December 2018, Bjork decided to reopen a previously discontinued investigation into three cases. Additional written evidence was obtained and more interviews were held with individuals in Sweden, Belgium, Britain, the United States and Spain, Bjork said in a statement.



“It has become clear to me that the operations were carried out in conflict with science and proven experience,” he added.

Macchiarini was fired from Sweden’s prestigious Karolinska Institute in March 2016 for breaching medical ethics after being accused of falsifying his resume and misrepresenting his work.


When Macchiarini’s first windpipe transplant was reported in the medical journal Lancet in 2008, it was hailed as a breakthrough in regenerative medicine. Macchiarini’s new airway — partly made using stem cells from the patient — was thought to herald a new era where new organs could be made in the laboratory.


Despite an independent commission in Sweden that found numerous problems in Macchiarini’s work, the Lancet has so far declined to retract the study.

Bjork said the operation had caused the victims “serious physical injuries and great suffering,” and “have been carried out with absolutely no legal basis.”

“I have made the assessment that the three operations are therefore to be considered as aggravated assault,” Bjork said. “It is the former surgeon at Karolinska University Hospital who alone should bear the criminal responsibility.”

Macchiarini earlier had disputed the accusations, saying they were false.

Of the 20 patients Macchiarini operated on to provide them with an artificial windpipe — from countries including Spain, Russian, Iceland, Britain and the U.S. — only three are still alive. Critics say Macchiarini skirted medical ethics to carry out dangerous procedures with no proven benefit and that he fabricated descriptions of this patients’ conditions.


Bjork declined to explain why he believes the operations were carried out with no legal basis. These details and explanations will first be made at the main hearing, he said, adding no date for that was set yet at the District Court in Solna, in northern Stockholm.

Last year, an Italian court sentenced Macchiarini to 16 months in prison for forging documents and abuse of office.

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Olsen reported from Copenhagen, Denmark. Maria Cheng in London contributed to this report.

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