# Blood and Marrow Transplant Clinical Trials Network Data Coordinating Center

> **NIH NIH U24** · MEDICAL COLLEGE OF WISCONSIN · 2021 · $8,815,066

## Abstract

Project Summary/Abstract
Hematopoietic stem cell transplantation (HCT) and cellular therapy offer curative therapy for a variety of
malignant and non-malignant blood diseases. This is a rapidly evolving field with active preclinical and clinical
development of new approaches to patient assessment, cell selection and manipulation, and pre- and post-
treatment therapy. New diagnostic and therapeutic strategies require evaluation in definitive clinical trials as
does the role of HCT versus other therapies. HCT and cellular therapy trials face unique challenges, including
the relatively small number of procedures performed at any single center, the diverse indications for treatment
requiring dissimilar approaches, the complex nature of the interventions, the risk of multiple complications in
the immediate post-treatment period, and the risk of important, though infrequent, late effects. The Blood and
Marrow Transplant Clinical Trials Network (BMT CTN) was established in 2001 to develop and execute
scientifically meritorious, prospective clinical trials to address these issues. The Network has launched 39 trials
with the support of a Data and Coordinating Center (DCC) formed though a Consortium including the Center
for International Blood and Marrow Transplant Research (CIBMTR) at the Medical College of Wisconsin, the
National Marrow Donor Program, and The Emmes Corporation. This Consortium proposes to continue
supporting the Network and managing the efficient development, implementation and completion of high-
quality Phase I-III clinical trials, including concept evaluation and prioritization, protocol development with
appropriate statistical designs, timely activation and accrual, monitoring for safety, compliance and data
accuracy, and analyzing and disseminating results. The DCC Consortium will coordinate and support all BMT
CTN activities maintaining a state-of-the-art database and systems for acquisition and storage of
biospecimens; ensuring data quality, laboratory compliance and adherence to regulatory requirements;
managing contractual arrangements and fiscal activities; monitoring and improving center and overall Network
performance; and supporting all Network Committees and activities with meeting planning and other logistical
support. The DCC will also continue to leverage Network resources and expertise through collaboration with
other scientific bodies including the National Cancer Institute-funded National Clinical Trials Network Groups,
NMDP's Be The Match BioTherapies, and CIBMTR's Working Committees and Stem Cell Therapeutic
Outcomes Database, as well as industry partners. These collaborations are imperative to maximize completion
of high quality and high priority HCT clinical trials, especially in the areas of HCT for non-malignant blood
disorders and novel cell/gene therapies and which often must involve non-transplant investigators.

## Key facts

- **NIH application ID:** 10249236
- **Project number:** 5U24HL138660-05
- **Recipient organization:** MEDICAL COLLEGE OF WISCONSIN
- **Principal Investigator:** Mary Maresca Horowitz
- **Activity code:** U24 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $8,815,066
- **Award type:** 5
- **Project period:** 2017-09-15 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10249236

## Citation

> US National Institutes of Health, RePORTER application 10249236, Blood and Marrow Transplant Clinical Trials Network Data Coordinating Center (5U24HL138660-05). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10249236. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*