Graft versus Host disease GvHD steroid resistant
Conditions
Interventions
Product Name: PTC-MSC
Pharmaceutical Form: Solution for infusion
Current Sponsor code: PTC-MSC
Concentration type: equal
Sponsors
AZIENDA OSPEDALIERA SAN GERARDO DI MONZA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 GVHD grade II-IV.;Secondary Objective: 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 aGvHD. 4. To document the overall survival of MSC infused patients for steroid refractory GvHD;Primary end point(s): To verify the absence of toxicity subsequent to experimental treatment | — |
Countries
Italy
Outcome results
None listed