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Yes, physicians may continue placing orders for investigational FMT preparations to treat patients with C. difficile infections not responsive to standard therapies.  

As of November 2022, the FDA has finalized a revised guidance governing the use of investigational FMT to treat recurrent C. difficile patients. Under this revised guidance, enforcement discretion—which previously permitted stool banks to provide investigational FMT for the treatment of recurrent C. difficile outside of a clinical trial—no longer applies to stool banks such as OpenBiome. To continue serving patients, stool banks must now provide access to investigational FMT preparations under an Investigational New Drug (IND) application.

With input from FDA, OpenBiome distributes investigational FMT preparations manufactured by the University of Minnesota under an Investigational New Drug (IND) application.

OpenBiome, in collaboration with our manufacturer, the University of Minnesota, distributes investigational FMT under an IND and are working with FDA to ensure that our regulatory filings are complete.

Investigational FMT material distributed by OpenBiome has been manufactured in accordance with current Good Manufacturing Practice (cGMP) regulations by the University of Minnesota. Stool donors undergo regular and rigorous screening for infectious agents and health risks to patients including SARS-CoV-2 and Monkeypox. Donated stool is directly tested for enteric pathogens and multi drug-resistant organisms including VRE, MRSA, ESBL, and CRE. More comprehensive information can be found in Investigator’s Brochures that are available upon request. 

Returning clinical partners will need to fill out a new registration form, which will be processed in a few days by OpenBiome. If approved, partners are free to start ordering. Shipping and handling procedures of investigational FMT material distributed by OpenBiome are largely the same so restarting your institute's investigational FMT program should be relatively simple.