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Evaluation of the Role of Mesenchymal Stem Cells in the Treatment of Graft Versus Host Disease

NCT00314483 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2007-07-06

No results posted yet for this study

Summary

Mesenchymal stem cells (MSC) have been shown to have immunosuppressive properties. Following a bone marrow/peripheral blood stem cell transplant, a proportion of patients develop a condition called 'graft versus host disease' (GVHD). In this condition the transplanted cells recognize the recipient as foreign and bring about an immune-mediated destruction of tissues. The treatment for this condition is to use drugs that will cause immunosuppression. A small subset of these patients develop a severe form of GVHD (Grade III or IV) which, in spite of the best currently available treatment, is associated with eventual death in more than 90% of cases. The investigators propose to use infusions of expanded MSC from the donor to treat this condition. A few reports on this approach have already been published in peer reviewed journals and preliminary results appear to be promising. The investigators are also aware that larger trials have been initiated to study this. After getting written informed consent, the investigators will infuse expanded MSC into patients who develop steroid-resistant GVHD.

Conditions

  • Graft vs Host Disease

Interventions

DRUG

Mesenchymal Stem Cell Infusion

Sponsors & Collaborators

  • Christian Medical College, Vellore, India

    lead OTHER

Principal Investigators

  • Vikram Mathews, MD · Christian Medical College, Vellore, India

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-06-30
Completion
2008-06-30

Countries

  • India

Study Locations

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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 NCT00314483 on ClinicalTrials.gov