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

NCT ID: NCT00314483

Last Updated: 2007-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Graft vs Host Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Mesenchymal Stem Cell Infusion

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Christian Medical College, Vellore, India

OTHER

Sponsor Role lead

Principal Investigators

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Vikram Mathews, MD

Role: PRINCIPAL_INVESTIGATOR

Christian Medical College, Vellore, India

Locations

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Department of Haematology, Christian Medical College

Vellore, Tamil Nadu, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Vikram Mathews, MD

Role: CONTACT

[email protected]
91-416-2282891

Alok Srivastava, MD, FRACP

Role: CONTACT

[email protected]
91-416-2282472

Facility Contacts

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Vikram Mathews, MD

Role: primary

[email protected]
91-416-2282891

Alok Srivastava, MD, FRACP

Role: backup

[email protected]
91-416-2282472

Other Identifiers

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CMCMSC_GVHD012006

Identifier Type: -

Identifier Source: org_study_id