OpenBiome Webinar

On August 9th 2022, we hosted a live Q&A featuring members of the University of Minnesota (UMN) Microbiota Therapeutics Program and the American Gastroenterological Association (AGA). The Q&A covered investigational FMT preparations manufactured by UMN and how your site can join the AGA FMT registry to support long-term research.

Key takeaways and an FAQ are shared below.

Key Takeaways

OpenBiome will continue distributing UMN-manufactured investigational FMT for patients suffering from recurrent C. difficile (rCDI) not responding to standard therapies. To access this material, a new registration form must be completed. This applies to all sites, even if you have an existing OpenBiome agreement.
Emergency Access Restriction Lifted: OpenBiome’s partnership with UMN has enabled us to lift the ‘emergency only’ shipping policy that was in place since August 2021. If you have patients that are eligible for an investigational FMT to treat rCDI, you may place an order without applying for emergency access.
Plans to Expand On-hand Inventory: As we have ramped up operations, we expanded access by allowing sites to maintain on-hand inventory. Partner sites can now maintain an inventory of up to 5 units of investigational FMT.

Frequently Asked Questions about UMN-Manufactured Investigational FMT

If you cannot access the BD Interlink™ blunt tip plastic cannula required for the use of UMN-Manufactured Investigational FMT, any equivalent size blunt tup plastic cannula should be an acceptable substitute. Do not use a metal tip to puncture the cryobag port. If you use an alternative cannula, please let us know how it goes. You may also see the preparation tutorial for UMN-Manufactured Investigational FMT.

Frequently Asked Questions about AGA FMT National Registry

The Fecal Microbiota Transplantation National Registry is a national data collection project. The data that AGA collects will allow clinicians to trace short-term and long-term health outcomes after investigational FMT. This includes research into long-term safety concerns such as development of chronic conditions (e.g., irritable bowel syndrome, obesity and diabetes). OpenBiome encourages all patients and physicians to participate in this project and help advance the future of investigational FMT.