The FDA collaborates with experts to facilitate the development of safe and highly effective FMT therapies for patients with most microbiome-associated diseases.
All practitioners using FMT to treat various digestive issues are required to submit an IND to the FDA, however, enforcement discretion is being considered to use the therapy in cases not responsive to standard treatments.
Several experts in collaboration with the FDA are currently working on forums, published on February 12, 2020, in the journal Cell Host & Microbe that are directed towards developing safe FMT therapies.
The aims of these current investigations include evaluations of various autologous FMT preparations, the establishment of the optimal bacterial composition of the transplanted preparations, and the safety of the patients.
While the use of FMT as a mainstream treatment is still unlikely in the near future, scientists are hoping to conduct placebo-based trials to test the efficacy of the relevant products soon.
3 Key Points
Kate Markey, from the Memorial Sloan Kettering Cancer Center, says, “The next steps are further clinical trials with the array of products either now available or in development. As current trials reach completion, the true potential of this therapy will become clear.”
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