We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00314483
First Posted: April 14, 2006
Last Update Posted: July 6, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Christian Medical College, Vellore, India
  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
Intervention Model: Single Group Assignment
Masking: None (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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00314483     History of Changes
Other Study ID Numbers: CMCMSC_GVHD012006
First Submitted: April 12, 2006
First Posted: April 14, 2006
Last Update Posted: July 6, 2007
Last Verified: July 2007

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