MedTrace Logo

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

NCT00136903 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-01-31

No results posted yet for this 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

  • Graft Vs Host Disease

Interventions

DRUG

Prochymal® - 2 Million cells/kg

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

DRUG

Prochymal®- 8 Million cells/kg

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

DRUG

Methylprednisolone

Methylprednisolone 2 mg/kg administered intravenously.

DRUG

Prednisone

Prednisone 2.5 mg/kg administered orally.

DRUG

Cyclosporine

Administered as prescribed by the caregiver.

DRUG

Tacrolimus

Administered as prescribed by the caregiver.

DRUG

Mycophenolate Mofetil

Administered as prescribed by the caregiver.

Sponsors & Collaborators

  • Mesoblast, Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher James, PA · Mesoblast, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-27
Primary Completion
2006-07-28
Completion
2008-07-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00136903 on ClinicalTrials.gov