International Fecal Bank Feasible

Fecal microbiota transplantation (FMT) is a proven therapy for recurrent C. difficile infection. A team of researchers from OpenBiome outlined plans for a depository for frozen stool from screened donors.

The goal is to have a consistent and safe product for use by clinicians who treat patients with this ailment.

Reporting at the Digestive Disease Week conference in Washington, DC, Mark Smith and colleagues at the company and at Massachusetts Institute of Technology in Cambridge, MA, note that “although FMT is a robust therapy, logistical barriers have hampered clinical uptake and heterogeneous screening and processing techniques have complicated comparisons across studies.”

The researchers describe the methods they have used in assessing potential donors, including “a 109-point assessment by a qualified medical profession to rule out risk factors for transmissible disease and potential microbiome-mediated conditions.” Donors who pass the first assessment are tested for 27 serological and stool-based assays for detection of communicable infectious agents.

Samples from those who qualify are processed and stored at minus 80 degrees Celsius, and are not released for use until donors pass a second round of testing to ensure the samples are safe and non-infectious.

The authors noted that their workflow is similar to one that has been adopted by more than 150 clinical institutions in over 36 states and the Netherlands.

“The workflow can be easily applied to IND-based studies beyond recurrent C. Difficile using the biologics master file registered with the FDA by the stool bank”.