The purpose of this study is to evaluate safety and efficacy using decidual stromal cell therapy for graft versus host disease after allogeneic hematopoietic stem cell transplantation. The hypothesis to be tested is that the cells are safe to infuse and that they have a positive clinical effect.
Patients with GVHD grade 2-4, will receive decidual stromal cells at approximately 1-2x10\^6 cells/kg at one or more occasions dependent on clinical response.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Karolinska Institutet
Stockholm, Sweden
RECRUITINGActuarial survival at six months after first DSC infusion
Time frame: 6 months after inclusion
Response at 28 days after onset of graft versus host disease
Response will be measured as: * Partial response (PR) if the patient has improved one grade in the overall GvH. * Complete response (CR) if the patient is free of GvH. * Non responder (NR) if the patient does not improve after treatment.
Time frame: 28 days after inclusion
Response at 84 days after onset of graft versus host disease
Response will be measured as: * Partial response (PR) if the patient has improved one grade in the overall GvH. * Complete response (CR) if the patient is free of GvH. * Non responder (NR) if the patient does not improve after treatment.
Time frame: Up to 84 days after inclusion
Response at 168 days after onset of graft versus host disease
Response will be measured as: * Partial response (PR) if the patient has improved one grade in the overall GvH. * Complete response (CR) if the patient is free of GvH. * Non responder (NR) if the patient does not improve after treatment.
Time frame: Up to 168 days after inclusion
Side effects
Adverse effects related to the treatment.
Time frame: Up to 6 months after inclusion
Incidence of severe infections
Severe bacterial, viral and fungal infections.
Time frame: Up to one year after inclusion
Disease free survival
Survival free from relapse.
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Time frame: Up to one year after inclusion