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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 because the information has not been verified recently.
Verified July 2007 by Christian Medical College, Vellore, India.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Christian Medical College, Vellore, India
ClinicalTrials.gov Identifier:
NCT00314483
First received: April 12, 2006
Last updated: July 3, 2007
Last verified: July 2007
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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

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.

  Eligibility

Ages Eligible for Study:   2 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314483

Contacts
Contact: Vikram Mathews, MD 91-416-2282891 vikram@cmcvellore.ac.in
Contact: Alok Srivastava, MD, FRACP 91-416-2282472 aloks@cmcvellore.ac.in

Locations
India
Department of Haematology, Christian Medical College Recruiting
Vellore, Tamil Nadu, India, 632002
Contact: Vikram Mathews, MD     91-416-2282891     vikram@cmcvellore.ac.in    
Contact: Alok Srivastava, MD, FRACP     91-416-2282472     aloks@cmcvellore.ac.in    
Principal Investigator: Vikram Mathews, MD            
Sponsors and Collaborators
Christian Medical College, Vellore, India
Investigators
Principal Investigator: Vikram Mathews, MD Christian Medical College, Vellore, India
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00314483     History of Changes
Other Study ID Numbers: CMCMSC_GVHD012006
Study First Received: April 12, 2006
Last Updated: July 3, 2007
Health Authority: Institutional Review Board. Christian Medical College, Vellore. India:

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

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013