CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
Prochymal® - 2 Million cells/kg +6 moredrug
Likely dose
Methylprednisolone 2 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00136903
NCT00136903Phase 2Completed
CompareCT.gov

A Phase II, Randomized Study to Evaluate the Safety and Efficacy of Prochymal® (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) For the Treatment of Acute GVHD in Patients Who Receive Allogeneic Hematopoietic Stem Cell Transplantation

Mesoblast, Inc.·interventional·Posted Aug 29, 2005·Updated Jan 31, 2022

In Brief

A Phase 2 clinical trial evaluating Prochymal® - 2 Million cells/kg, Prochymal®- 8 Million cells/kg, and 5 other interventions for Graft Vs Host Disease. Completed, enrolled 32 participants across 9 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGraft Vs Host Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 29, 2005
Enrollment StartApr 27, 2005
Primary CompletionJul 28, 2006
Study CompletionJul 14, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 20.8 years ago

Interventions

Prochymal® - 2 Million cells/kgdrug

2 million hMSCs/kg actual body weight, IV on study Days 1 and 4

Prochymal®- 8 Million cells/kgdrug

8 million hMSCs/kg actual body weight IV on study Days 1 and 4

Methylprednisolonedrug

Methylprednisolone 2 mg/kg administered intravenously.

Prednisonedrug

Prednisone 2.5 mg/kg administered orally.

Cyclosporinedrug

Administered as prescribed by the caregiver.

Tacrolimusdrug

Administered as prescribed by the caregiver.

Mycophenolate Mofetildrug

Administered as prescribed by the caregiver.