Demonstration of safety of microbiota transplant therapy in stem cell transplant and leukemia patients

Date:
July 6, 2023
Source:
University of Minnesota Medical School
Summary:
A new study has demonstrated the safety of using microbiota
transplant therapy (MTT) in patients with acute myeloid leukemia
(AML) -- a type of blood cancer -- and recipients of hematopoietic
cell transplantation (HCT).


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FULL STORY ========================================================================== Published in theJournal of Clinical Oncology, University of Minnesota
Medical School researchers led a study that demonstrated the safety
of using microbiota transplant therapy (MTT) in patients with acute
myeloid leukemia (AML) -- a type of blood cancer -- and recipients of hematopoietic cell transplantation (HCT).

Current treatment for patients with AML and who receive HCT includes
powerful chemotherapy, which can damage their immune system and intestinal lining.

Because of this, patients typically require antibiotics to fight and
prevent infections. These antibiotics also kill healthy gut microbes,
which may worsen treatment outcomes. The goal of MTT is to restore
beneficial microbes in the recipient's gut.

"Microbiota transplants are classified as drugs by the U.S. Food and
Drug Administration. However, they truly are an entirely different
and new class of drugs, and we need to develop and understand their pharmacology. This requires standardized formulations and figuring out
the optimal dosing regimens," said Alexander Khoruts, MD, director of
the University of Minnesota Microbiota Therapeutics Program.

In a randomized, double-blind study, the research team compared the
outcomes of MTT for two groups: patients with AML and HCT recipients. They
used a novel, standardized preparation of donor microbiota called
MTP-101C, which is formulated in capsules that are taken orally. After
each course of antibiotics, patients received either MTT or a placebo. The study found the rate of infections was lower in HCT and AML patients
that received active MTT relative to the patients that received the
placebo. However, the difference did not reach statistical significance.

Overall, the study showed MTT was safe and partially improved the
imbalance of gut bacteria in patients who had received HCT or had
AML. However, it did not significantly reduce the rate of infections in
these patients.

These results will serve as the basis for a larger follow-up study, which
will use a more aggressive MTT protocol with the microbiota compound manufactured by the University of Minnesota Microbiota Therapeutics
Program. The program has been the world leader in the development and manufacturing of microbiota-based therapeutics over the past decade. It
is working to develop effective and practical restorative microbiota
therapies for multiple clinical indications, some of which include
infections with Clostridioides difficile, inflammatory bowel disease
and different applications in cancer.

This study was funded largely through local philanthropy, including the Chainbreaker Cancer Fundraiser bike event held in 2017, as well as the nonprofit Achieving Cures Together. Additional support was provided
by the National Institutes of Health's National Center for Advancing Translational Sciences [KL2TR002492 and UL1TR002494] and the National
Cancer Institute [P30CA07759].

* RELATED_TOPICS
o Health_&_Medicine
# Leukemia # Diseases_and_Conditions # Wounds_and_Healing
# Today's_Healthcare # Patient_Education_and_Counseling #
Lung_Cancer # Pharmacology # Multiple_Sclerosis_Research
* RELATED_TERMS
o Bone_marrow_transplant o Leukemia o Skin_grafting o
Kidney_transplantation o Stem_cell o Adult_stem_cell o Cancer
o Bone_marrow

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========================================================================== Journal Reference:
1. Armin Rashidi, Maryam Ebadi, Tauseef Ur Rehman, Heba Elhusseini,
David
Kazadi, Hossam Halaweish, Mohammad H. Khan, Andrea Hoeschen,
Qing Cao, Xianghua Luo, Amanda J. Kabage, Sharon Lopez, Shernan
G. Holtan, Daniel J. Weisdorf, Alexander Khoruts, Christopher
Staley. Randomized Double- Blind Phase II Trial of Fecal Microbiota
Transplantation Versus Placebo in Allogeneic Hematopoietic Cell
Transplantation and AML. Journal of Clinical Oncology, 2023; DOI:
10.1200/JCO.22.02366 ==========================================================================

Link to news story: https://www.sciencedaily.com/releases/2023/07/230706124523.htm

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