Status:
COMPLETED
Donor Mesenchymal Stem Cell Infusion in Treating Patients With Acute or Chronic Graft-Versus-Host Disease After Undergoing a Donor Stem Cell Transplant
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Donor mesenchymal stem cell infusion may be an effective treatment for acute or chronic graft-versus-host disease caused by a donor stem cell transplant. PURPOSE: This phase I trial is stu...
Detailed Description
OBJECTIVES: Primary * Determine the safety of donor mesenchymal stem cell (MSC) infusion in patients with acute or extensive chronic graft-vs-host disease (GVHD) after undergoing HLA-identical sibli...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Developed acute graft-vs-host disease (GVHD) of clinical grade II-IV or extensive chronic GVHD after undergoing HLA-identical sibling donor hematopoietic stem cell transplant for any indication, malignant or nonmalignant
- Requires systemic immunosuppressive therapy with systemic corticosteroids (methylprednisone dose 2 mg/kg/day or equivalent) and concurrent cyclosporine or tacrolimus
- May have been enrolled on an institutional allogeneic stem cell transplant protocol using either ablative or nonmyeloablative preparative regimens
- No evidence of relapsed or progressive malignant disease at the time of GVHD
- PATIENT CHARACTERISTICS:
- Not pregnant
- Negative pregnancy test
- Creatinine clearance ≥ 20 mL/min
- Oxygen saturation ≥ 90% on room air
- No severe or symptomatic restrictive or obstructive lung disease or respiratory failure requiring ventilator support
- No uncontrolled hypertension or congestive heart failure, active angina pectoris requiring the use of nitrates, myocardial infarction within the past 6 months, or major ventricular arrhythmia or cardiac failure requiring active treatment
- No significant organ dysfunction
- No active severe infections, including sepsis, pneumonia with hypoxemia, persistent bacteremia, or meningitis
- Fever without a source is allowed
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00361049
Start Date
September 1 2004
End Date
November 1 2010
Last Update
November 5 2010
Active Locations (8)
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1
Geauga Regional Hospital
Cleveland, Ohio, United States, 44024
2
Lake/University Ireland Cancer Center
Cleveland, Ohio, United States, 44060
3
Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
4
University Suburban Health Center
Cleveland, Ohio, United States, 44121