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Completed Phase 3 Interventional

Efficacy and Safety of Adult Human Mesenchymal Stem Cells to Treat Steroid Refractory Acute Graft Versus Host Disease (GVHD)

ClinicalTrials.gov ID: NCT00366145

Public ClinicalTrials.gov record NCT00366145. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 30, 2026, 1:41 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Prochymal® (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) Infusion for the Treatment of Patients Who Have Failed to Respond to Steroid Treatment for Acute GVHD

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to evaluate the efficacy and gather additional safety information for Prochymal® in participants who have failed to respond to steroid treatment of Grades B-D acute GVHD.

Study identification

NCT ID
NCT00366145
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Mesoblast, Inc.
Industry
Enrollment
260 participants

Conditions and interventions

Interventions

Biological · Drug

Eligibility (public fields only)

Age range
6 Months to 70 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 17, 2006 (Actual)
Primary completion
Dec 26, 2008 (Actual)
Completion
May 28, 2009 (Actual)
Last update posted
Feb 10, 2022

2006 – 2009

United States locations

U.S. sites
47
U.S. states
28
U.S. cities
38
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35249 —
Arizona Cancer Center Tucson Arizona 85724 —
City of Hope Duarte California 91010 —
Univeristy of California San Francisco San Francisco California 94143 —
Yale New Haven Hospital New Haven Connecticut 06520 —
University of Miami Miami Florida 33136 —
All Children's Hospital St. Petersburg Florida 33701 —
Emory University Atlanta Georgia 30322 —
Northside Hospital Atlanta Georgia 30342 —
Northwestern Center for Clinical Research Chicago Illinois 60611 —
Rush University Medical Center Chicago Illinois 60612 —
University of Illinois - Chicago Chicago Illinois 60612 —
Indiana Blood and Bone Marrow Transplant Center Beech Grove Indiana 46107 —
Univeristy of Iowa Hospitals and Clinics Iowa City Iowa 52242 —
University of Kansas Medical Center Kansas City Kansas 66160 —
University of Louisville Louisville Kentucky 40202 —
Louisiana State University Shreveport Louisiana 71130 —
University of Maryland/Greenbaum Baltimore Maryland 21201 —
Tufts-New England Medical Center Boston Massachusetts 02111 —
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 —
Dana-Farber Cancer Institute Boston Massachusetts 02215 —
Karmanos/Wayne State University Detroit Michigan 48201 —
Mayo Clinic Rochester Rochester Minnesota 55905 —
Univeristy of Mississippi Medical Center Jackson Mississippi 39216 —
University of Nebraska Omaha Nebraska 68198 —
Hackensack University Medical Center Hackensack New Jersey 07601 —
Roswell Park Buffalo New York 14263 —
New York Presbyterian Hospital New York New York 10021 —
Mount Sinai Medical Center New York New York 10029 —
Columbia University/New York Presbyterian Hospital New York New York 10032 —
University of Rochester Rochester New York 14642 —
New York Medical College Valhalla New York 10595 —
Duke University Durham North Carolina 27710 —
Wake Forest Univeristy School of Medicine Winston-Salem North Carolina 27157 —
Oregon Health and Science University Portland Oregon 97239 —
Penn State Hershey Medical Center Hershey Pennsylvania 17033 —
Western Pennsylvania Cancer Institute Pittsburgh Pennsylvania 15224 —
Medical University of South Carolina Charleston South Carolina 29425 —
Texas Cancer Center at Medical City Dallas Texas 75230 —
Baylor University Dallas Texas 75246 —
Univeristy of Texas Southwestern Medical Center Dallas Texas 75390 —
MD Anderson Cancer Center Houston Texas 77030 —
Texas Research Center San Antonio Texas 78229 —
Virginia Commonwealth/Massey Cancer Center Richmond Virginia 23298 —
Fred Hutchinson Cancer Research Center Seattle Washington 98109-1024 —
University of Wisconsin Madison Madison Wisconsin 53792 —
Medical College of Wisconsin Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00366145, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 10, 2022 · Synced Oct 30, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00366145 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →