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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2007 by Christian Medical College, Vellore, India.
Recruitment status was:  Recruiting
Information provided by:
Christian Medical College, Vellore, India Identifier:
First received: April 12, 2006
Last updated: July 3, 2007
Last verified: July 2007
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.

Condition Intervention Phase
Graft vs Host Disease
Drug: Mesenchymal Stem Cell Infusion
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Potential Mesenchymal Stem Cells for the Treatment of Graft Versus Host Disease Following an Allogeneic Stem Cell Transplant

Resource links provided by NLM:

Further study details as provided by Christian Medical College, Vellore, India:

Primary Outcome Measures:
  • Control of GVHD [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • Infusional toxicity [ Time Frame: 48 hours ]
  • Risk of relapse [ Time Frame: One year ]

Estimated Enrollment: 25
Study Start Date: June 2007
Estimated Study Completion Date: June 2008
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.


Ages Eligible for Study:   2 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00314483

Contact: Vikram Mathews, MD 91-416-2282891
Contact: Alok Srivastava, MD, FRACP 91-416-2282472

Department of Haematology, Christian Medical College Recruiting
Vellore, Tamil Nadu, India, 632002
Contact: Vikram Mathews, MD    91-416-2282891   
Contact: Alok Srivastava, MD, FRACP    91-416-2282472   
Principal Investigator: Vikram Mathews, MD         
Sponsors and Collaborators
Christian Medical College, Vellore, India
Principal Investigator: Vikram Mathews, MD Christian Medical College, Vellore, India
  More Information Identifier: NCT00314483     History of Changes
Other Study ID Numbers: CMCMSC_GVHD012006
Study First Received: April 12, 2006
Last Updated: July 3, 2007

Keywords provided by Christian Medical College, Vellore, India:
Mesenchymal stem cells
Steroid refractory GVHD

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases processed this record on May 25, 2017