The study is intended for patients after allogeneic hematopoietic stem cell transplantation (from related and unrelated donors) with steroid-refractory or steroid-dependent GVHD of any type: - Steroid refractory acute GVHD grade II-IV - Steroid refractory chronic GVHD - Steroid-dependent chronic "late onset" acute GVHD or overlap GVHD
Conditions
Interventions
Product Name: mesenchymal stem cells
Product Code: MSC
Pharmaceutical Form: Suspension for injection
Sponsors
Fakultní nemocnice Plzen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for patients: - Age 18-70 years - A signed informed consent - Status after allogeneic HSCT complicated with GVHD (any type) with effective levels of CsA (min 150 ng/ml) and: a) no response to corticosteroids at a minimum dose of 1mg/kg administered for at least 2 weeks or b) GVHD progressing during the abovementioned treatment or c) corticosteroid-dependent GVHD , ie, GVHD responding to corticosteroids, but with the necessity of continuous administration of a minimum dose of 0.1 mg Medrol/kg/day (or equivalent) or d) GVHD permanently requiring combination of ciclosporin and another immunosuppressant (eg. MMF etc.), while steroids are from any reason contraindicated or not tolerated Inclusion criteria for donors: - A signed informed consent - Negativity for infectious disease markers according to the standard requirements (SÚKL, JACIE, WMDA) Are the trial subjects under 18? no 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: Exclusion criteria for patients: - poor performance status with expected survival 65 years - positive testing for infectious diseases markers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Determine the effect of MSC infusion from unrelated, HLA identical or non-identical donors on steroid refractory or steroid-dependent GVHD of any type - Analyze changes in immunological laboratory parameters after the administration of mesenchymal stem cells ; Secondary Objective: - Establish the safety of MSC infusion in patients after allogeneic hematopoietic stem cell transplantation - Analyze the effect of MSC infusion on the risk of relapse of primary disease - Analyze the occurence of infectious complications after infusion of MSC - Monitor overall survival after infusion of MSC - Monitor quality of life after the MSC - Observe the dose of corticosteroids ; Primary end point(s): - relieve the symptoms of GVHD - achieving complete or partial clinical response according to the consensus criteria - reduction of pro-inflammatory immunological laboratory parameters - absence of relapse of primary disease ;Timepoint(s) of evaluation of this end point: The evaluation will be performed before the application of MSC and then 14 days, 30 days, 60 days, 100 days, 6 months and 12 months after after the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - improving the quality of life of patients (standardized questionnaire) - reduction of the dose of corticosteroids ;Timepoint(s) of evaluation of this end point: The evaluation will be performed before the application of MSC and then 30 days, 100 days and 12 months after after the treatment. | — |
Countries
Czech Republic
Contacts
Public ContactHematologicko-onkologické oddelení
Fakultní nemocnice Plzen
Outcome results
None listed