EUCTR2008-007869-23-ITActive, not recruitingNot Applicable
Mesenchymal Stromal Cells (MSC) for the treatment of severe (grade II-IV) steroid-resistant Graft Versus Host Disease (GVHD): a phase I trial - MSC-GvHD
AZIENDA OSPEDALIERA SAN GERARDO DI MONZA0 sitesStarted: July 23, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Informed consent. 2. Patients between 2 and 65 years of age 3. Patients are required to meet the following inclusion criteria: Any patient that has undergone allogeneic stem cell transplantation with steroid refractory grades II-IV acute GvHD either occurring post transplant, or induced by donor lymphocyte infusions (DLI) or T-cell add back, or chronic steroid refractory GVHD in acute phase. a) Steroids have been given, for instance metilprednisolone 2 mg/kg/day, for at least 72h in case of progressive acute GvHD, 5 days in case of stable acute GVHD (grade II to IV) or chronic GvHD in active phase. b) Despite this treatment, the patient has unresponsive GvHD after 5 days, or progressive acute GvHD after 72 hours.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1. Inability to obtain informed consent. 2. Patients/subjects with documented uncontrolled EBV, CMV or fungal infection 3. Patients in poor clinical conditions with life expectancy of less than 30 days.
Investigators
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