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

NCT00366145 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2022-02-10

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

Prochymal®

2 infusions of 2 million cells/kg per week for 4 weeks

DRUG

Placebo

2 infusions per week for 4 weeks

DRUG

Standard of Care for GVHD

Institutionally defined standard of care (e.g., maintenance of steroid treatment and the addition of a second-line therapy)

Sponsors & Collaborators

  • Mesoblast, Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher James, PA · Mesoblast, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-08-17
Primary Completion
2008-12-26
Completion
2009-05-28
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Italy
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT00366145 on ClinicalTrials.gov