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.