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fecal microbiota transplant (Masonic Cancer Center)

Development stage
Unknown
Lead developer
University of Minnesota
Modality
Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Cell Therapies, Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics
Administration
Oral
01

Overview

Fecal microbiota transplant (FMT) is an investigational live biotherapeutic product being developed by the Masonic Cancer Center and the University of Minnesota. It is being evaluated in a randomized, double-blind, placebo-controlled Phase 2 clinical trial (NCT03692520) for the prevention of infections (bacterial, viral, and fungal) and graft-versus-host disease (GVHD). The trial enrolls patients with acute myeloid leukemia (AML) undergoing intensive chemotherapy and recipients of allogeneic hematopoietic cell transplantation (allo-HCT). [4] The therapy, administered as oral capsules, aims to restore a healthy gut microbiome that has been disrupted by antibiotics and chemotherapy, thereby potentially reducing infection rates and modulating the immune system to prevent GVHD. [3, 7] While the trial did not meet its primary endpoint of reducing overall infection rates, analysis suggests that donor microbiota engraftment may be associated with a lower rate of acute GVHD. [3, 4]

Other names
Fecal Microbiota Transplant (FMT)

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