Program History Timeline

2019
November 4

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.

 

July 7

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.

2017
January 1

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.

2015
January 7

First Capsule Treatment

The first treatment with capsule preparation of freeze-dried microbiota was done in January 2015.

2013
September 1

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.

 

 

July 1

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.

May 1

FDA Hearing

On this day, the FDA workshop classified FMT as a drug and a biologic.

2012
January 31

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.

 

January 1

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.

2011
December 1

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.

 

2008
August 21

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.

 

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