# BMT CTN Core: Baylor College of Medicine Consortium

> **NIH NIH UG1** · BAYLOR COLLEGE OF MEDICINE · 2024 · $242,183

## Abstract

PROJECT SUMMARY/ABSTRACT
In this application, we are applying for renewal of our consortium between Baylor College of Medicine in Houston
TX and Children’s National Hospital in Washington DC as a Core Clinical Center in the BMT CTN Network. Our
consortium performs over 350 transplants per year (over 150 pediatric and over 200 adult procedures) and also
infuses over 150 immune effector cell products (Investigational and commercial products) per year. We also
have strong programs in non-malignant disorders performing over 300 allogeneic transplants for non-malignant
hematologic, metabolic and immunologic disorders in the last 5 years. Furthermore, our centers have extensive
experience developing, implementing and completing complex biological therapies with cell and gene therapy
products and have successfully sponsored and implemented over 140 cell and gene therapy studies under more
than 70 investigator initiated INDs, including multiple Phase II multicenter studies. We have also been strong
contributors to BMT CTN with 161 patients enrolled in the last funding period. Importantly we have been highly
successful in matching CTN clinical trial accrual to the diverse populations of our two catchment areas including
27.8% Hispanic, 19.6% African American and 3.5% Asian subjects. Although both centers have strengths in cell
therapies we selected a research proposal based on the laboratory work of Dr. Pavan Reddy a physician scientist
who directs the NCI-designated comprehensive cancer center at Baylor College of Medicine because we
hypothesize that this is a highly feasible strategy with strong potential to appreciably impact the incidence of graft
versus host disease (GVHD) which remains a significant cause of morbidity and mortality in patients post
hematopoietic cell transplant. (HCT) In preclinical studies, Dr Reddy discovered that butyrate was significantly
decreased in intestinal epithelial cells of mice experiencing GVHD, and that increasing intestinal butyrate-
producing bacteria reduced the severity of experimental acute gastrointestinal GVHD. Administration of resistant
potato starch (RPS), as a prebiotic, promoted an increase in butyrogenic bacteria and intestinal levels of butyrate.
In a pilot study testing this intervention in the clinic, administration of RPS to allogeneic transplant recipients was
feasible and was associated with significant alterations in intestinal and plasma metabolites. A phase II trial
examining the effect of RPS on GVHD in allo-HCT recipients is underway and, in this application, we propose a
randomized Phase III trial to evaluate the effects of modulating the microbiome to reduce GVHD in a larger
multicenter cohort. We assert that this approach requires multicenter testing to confirm whether the microbiome
modulation is reproducible in diverse populations in different geographic locations and to determine if there is a
significant reduction in the incidence of GVHD.

## Key facts

- **NIH application ID:** 10935871
- **Project number:** 2UG1HL108945-14
- **Recipient organization:** BAYLOR COLLEGE OF MEDICINE
- **Principal Investigator:** Catherine M. Bollard
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $242,183
- **Award type:** 2
- **Project period:** 2011-08-08 → 2031-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10935871

## Citation

> US National Institutes of Health, RePORTER application 10935871, BMT CTN Core: Baylor College of Medicine Consortium (2UG1HL108945-14). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10935871. Licensed CC0.

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