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Safety and Efficacy of Prochymal for the Salvage of Treatment-Refractory Acute GVHD Participants

NCT00284986 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-10-30

No results posted yet for this study

Summary

This study is designed to evaluate the safety and efficacy of Prochymal® (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) in participants experiencing treatment-refractory acute GVHD, Grades III-IV, that is refractory to standard first-line therapies and at least one second-line therapy.

Conditions

Interventions

DRUG

Prochymal

Intravenous infusion of ex-vivo cultured adult human mesenchymal stem cells

Sponsors & Collaborators

  • Mesoblast, Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher James, PA · Mesoblast, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-18
Primary Completion
2006-04-25
Completion
2007-02-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00284986 on ClinicalTrials.gov