Graft vs Host Disease Clinical Trial
Official title:
Mesenchymal Stromal Cells (MSC) for the Treatment of Severe (Grade II-IV) Steroid-resistant Graft Versus Host Disease (GVHD): a Phase I Trial
This is a bicentric, prospective, non randomized study. Pediatric and adult patients will be
treated.
Rationale: MSC have shown promising effects by reversal of severe therapy-resistant acute
GvHD. As a common therapeutic line of action is not shared for steroid resistant GVHD, it is
important to establish the toxicity and the feasibility of preparation and infusion of third
party MSCs for acute steroid resistant GVHD and acute phases of chronic steroid resistant
GVHD.
A total of 10 patients (pediatric and adults) need to be enrolled in the study. Patients who
present clinical signs of either acute or chronic steroid resistant GVHD will receive by
intravenous infusion at least two fixed doses of mesenchymal stem cells with 5 to 7 days of
interval one from the other, derived from HLA unrelated donor different from the HSC donor
(third party donor) regardless of the rate of HLA mismatch.
Primary objectives are to establish the feasibility and the toxicity of preparation and
infusions of third party MSCs for the treatment of steroid resistant acute and acute phases
of chronic grade II-IV GVHD.
Secondary objectives are:
1. To document the efficacy of MSC infusion in steroid resistant acute and acute phases of
chronic GVHD grade II-IV.
2. To document the rate of GVHD recurrence in MSCs infused patients.
3. To document relapse of hematological malignancies post MSC infusions in patients
undergoing MSCs treatment for steroid refractory GvHD.
4. To document the overall survival of MSC infused patients for steroid refractory GvHD.
n/a
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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