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

July 3, 2007 updated by: Christian Medical College, Vellore, India

Evaluation of Potential Mesenchymal Stem Cells for the Treatment of Graft Versus Host Disease Following an Allogeneic Stem Cell Transplant

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.

Study Overview

Status

Unknown

Conditions

Graft vs Host Disease

Intervention / Treatment

Drug: Mesenchymal Stem Cell Infusion

Detailed Description

A single center non randomized, non blinded Phase I/II clinical trial is proposed to study the role of mesenchymal stem cells (MSC) in the management of steroid refractory graft versus host disease (GVHD) following an allogeneic stem cell transplant.

Patients who develop grade II to IV GVHD following an allogeneic stem cell transplant will be enrolled. MSC will be expanded from the donors of all patients who develop GVHD. Expanded MSC will be infused at a dose of 1-2 million cells/kg in patients who have steroid refractory GVHD.

Response to therapy will be studied using established criteria for grading GVHD.

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2
Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

India
- Tamil Nadu
  - Vellore, Tamil Nadu, India, 632002
    - Recruiting
    - Department of Haematology, Christian Medical College
    - Contact:
      
      Vikram Mathews, MD
      
      Phone Number: 91-416-2282891
      
      Email: vikram@cmcvellore.ac.in
    - Contact:
      
      Alok Srivastava, MD, FRACP
      
      Phone Number: 91-416-2282472
      
      Email: aloks@cmcvellore.ac.in
    - Principal Investigator:
      
      Vikram Mathews, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Informed consent obtained from patient and donor
Any patient who has undergone HLA-matched related allogeneic stem cell transplantation with steroid refractory Grades II-IV acute GVHD
Prednisolone 2 mg/kg/day (or equivalent doses of methylprednisolone, etc.) for at least one week

Exclusion Criteria:

Invasive fungal disease
Active cytomegalovirus (CMV)/Epstein-Barr virus (EBV)/varicella disease
Relapsed malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Control of GVHD Time Frame: 8 weeks	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Infusional toxicity Time Frame: 48 hours	48 hours
Risk of relapse Time Frame: One year	One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christian Medical College, Vellore, India

Investigators

Principal Investigator: Vikram Mathews, MD, Christian Medical College, Vellore, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Study Completion (Anticipated)

June 1, 2008

Study Registration Dates

First Submitted

April 12, 2006

First Submitted That Met QC Criteria