OpenBiome’s Collaboration with the University of Minnesota
OpenBiome is collaborating with the University of Minnesota’s (UMN) Microbiota Therapeutics Program to ensure that patients with recurrent C. difficile infections have access to fecal microbiota transplantation (FMT) until an FDA-approved alternative is available.
Maintaining Safe Access to FMT
OpenBiome is distributing FMT preparations manufactured under Good Manufacturing Practice by the University of Minnesota (UMN). This new source of FMT material will serve as a bridge to FDA-approved alternatives to FMT, which are expected to become available to patients in 2023.
“Our team cares deeply about patients and specializes in the clinical and operational aspects of running a bank of fecal microbiota-based products. We’re excited to team up with OpenBiome and its extensive network of clinical partners to bridge the gap in patient care.”
— Dr. Alexander Khoruts, Medical Director of the University of Minnesota Microbiota Therapeutics Program
How to Administer a UMN-manufactured FMT
FMT preparations manufactured by the University of Minnesota are stored in a cryobag and require a different administration protocol than that of OpenBiome-manufactured FMT preparations.
In this video, Dr. Alexander Khoruts from the University of Minnesota demonstrates how to prepare for patient administration.
- Thaw cryobag on ice for at least 30 minutes. FMT preparations must be administered or discarded within 6 hours of thawing.
- You will need the following materials: BD Interlink™ blunt tip plastic cannula (Item number 303345) or a cannula of the equivalent size, normal saline, 30 or 60mL slip tip syringes, and a graduated beaker.
Treat Patients with an FMT manutured by UMN
OpenBiome is fulfilling orders for all clinical partners with identified recurrent C. difficile patients or who wish to keep a stock of FMT preparations at their facility.
Information and Resources for:
Frequently Asked Clinical Questions
Dr. Alexander Khoruts has provided clinical guidance for some frequently asked questions.