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NCT00136903 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Graft Vs Host Disease, sponsored by Mesoblast.

Completed
Registry status
Phase 2
Development phase
32
Enrollment target
9
Study locations

NCT00136903 is a Phase 2 study of Graft Vs Host Disease that has completed, run by Mesoblast. The registered enrollment target is 32 participants, below the 137-participant average among 36 other Graft Vs Host Disease trials with a reported enrollment target (77% lower). The trial reports 9 study locations across 6 states.

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The verdict

NCT00136903, a Phase 2 study of Graft Vs Host Disease, has completed, sponsored by Mesoblast.

COMPLETED
Registry status
Phase 2
Development phase
32 participants
Enrollment target
9
Study locations

Study Summary

To establish the safety and efficacy of two dose levels of ex-vivo cultured adult human mesenchymal stem cells (hMSCs) (Prochymal®) in participants experiencing acute GVHD, Grades II-IV, post hematopoietic stem cells (HSC) transplant.

Conditions Studied

Interventions

  • DRUG Prednisone
  • DRUG Methylprednisolone
  • DRUG Cyclosporine
  • DRUG Prochymal® - 2 Million cells/kg
  • DRUG Prochymal®- 8 Million cells/kg

Study Locations (9)

New York

  • Roswell Park Cancer Institute - Buffalo
  • Mt. Sinai Hospital - New York
  • University of Rochester - Rochester
  • New York Medical College - Valhalla

Indiana

  • St. Francis Hospital - Indianapolis

Missouri

  • Kansas City Cancer Centers - BMT - Kansas City

New Jersey

  • The Cancer Center at Hackensack University - Hackensack

Texas

  • MD Anderson Cancer Center - Houston

Wisconsin

  • Medical College of Wisconsin, FEC - Milwaukee

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2005-04-27
Est. Completion 2008-07-14
Phase Phase 2

Sponsor

Mesoblast

25 total trials

What the Registry Record Tells You About NCT00136903

The ClinicalTrials.gov registry entry for NCT00136903 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 137-participant average among 36 other Graft Vs Host Disease trials with a reported enrollment target (77% lower). The listed sponsor is Mesoblast, which has 25 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Graft Vs Host Disease appearing as the primary indexed condition, and to 5 interventions - of which Prednisone is the first listed.

NCT00136903 reports 9 study locations spanning 6 distinct geographic areas - top geographies include New York, Indiana, Missouri.

Frequently Asked Questions

What is clinical trial NCT00136903 about?

NCT00136903 is a clinical study titled "Safety and Efficacy Study of Adult Human Mesenchymal Stem Cells to Treat Acute Graft Versus Host Disease (GVHD)". To establish the safety and efficacy of two dose levels of ex-vivo cultured adult human mesenchymal stem cells (hMSCs) (Prochymal®) in participants experiencing acute GVHD, Grades II-IV, post hematopoietic stem cells (HSC) transplant.

What is the current status of trial NCT00136903?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2005-04-27. Estimated completion is 2008-07-14.

What conditions does trial NCT00136903 study?

This clinical trial studies the following conditions: Graft Vs Host Disease.

What interventions are being tested in trial NCT00136903?

The interventions under investigation include: Prednisone (DRUG), Methylprednisolone (DRUG), Cyclosporine (DRUG), Prochymal® - 2 Million cells/kg (DRUG), Prochymal®- 8 Million cells/kg (DRUG).

Who is sponsoring clinical trial NCT00136903?

This trial is sponsored by Mesoblast, which has 25 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00136903 being conducted?

This trial has 9 study locations across Indiana, Missouri, New Jersey, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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