Program History Timeline
FDA Enforcement Discretion Hearing
Amanda Kabage, our Research Program Manager, spoke at a public FDA hearing to discuss the clinical evidence for safety and efficacy of FMT treatment for recurrent C. difficile patients under the FDA’s enforcement discretion policy. View Here.
FMT to IMT
We renamed the treatment of FMT to IMT: Intestinal Microbiota Transplantation. This was published in the American Journal of Gastroenterology in 2019. Click here.
Re-established GMP Manufacturing
We re-established GMP manufacturing independent of commercial funding in 2017 with the help of philanthropic funding from Achieving Cures Together, Hubbard Broadcasting Foundation, and Maslowski Charitable Trust.
First Capsule Treatment
The first treatment with capsule preparation of freeze-dried microbiota was done in January 2015.
Treatment of fulminant C. difficile infection
The FMT protocol for treatment of fulminant C. difficile infection was published in the Journal of Clinical Gastroenterology in September 2013. Click here to read more.
Enforcement Discretion Policy
The FDA announced the enforcement discretion policy with respect to regulation of FMT. This policy allows physicians to use FMT without federal regulatory oversight in the treatment of C. difficile infections that do not respond to standard therapies.
On this day, the FDA workshop classified FMT as a drug and a biologic.
Early Development of Material Preparation
Our protocols for material preparation developed gradually, evolving from crudely blended stool in the endoscopy suite to development of frozen, liquid preparations enriched for fecal microbiota. The early donor program was developed in parallel over several years. The protocol for standardizing the donor selection and preparation of cryopreserved microbiota was published online on January 31, 2012. Click Here.
Development of GMP protocols
Development of GMP protocols began at MCT. Our program was working in collaboration with a start-up company called NuQure, which later became CIPAC, then Crestovo, and ultimately Finch Therapeutics.
Demonstration of Microbiota Engraftment
Demonstration of microbiota engraftment was central to the new terminology of what was formerly known by various names, e.g., fecal bacteriotherapy, to ‘Fecal Microbiota Transplantation’. The term was first used in December 2011. Click here.
Our First FMT
Our first FMT was completed by Dr. Khoruts. The donor was the patient’s husband. Click here to find the case report describing this patient, which contained the first documentation of engraftment of donor microbiota. Published in May 2010 in the Journal of Clinical Gastroenterology.