Graft vs Host Disease
Conditions
Keywords
Stem Cell Transplantation, Decidual Stromal Cells
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALDecidual Stromal Cells thawed in plasma
BIOLOGICALDecidual Stromal Cells thawed in human albumin
Sponsors
Karolinska University Hospital
Karolinska Institutet
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Acute graft versus host disease grade 2-4. * Are on calcineurin inhibitor and high dose corticosteroids.
Exclusion criteria
None.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Actuarial survival at six months after first DSC infusion | 6 months after inclusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response at 84 days after onset of graft versus host disease | Up to 84 days after inclusion | 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. |
| Response at 168 days after onset of graft versus host disease | Up to 168 days after inclusion | 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. |
| Response at 28 days after onset of graft versus host disease | 28 days after inclusion | 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. |
| Incidence of severe infections | Up to one year after inclusion | Severe bacterial, viral and fungal infections. |
| Disease free survival | Up to one year after inclusion | Survival free from relapse. |
| Side effects | Up to 6 months after inclusion | Adverse effects related to the treatment. |
Countries
Sweden
Contacts
Primary ContactOlle Ringdén, MD, PhD
Backup ContactHelen Kaipe, PhD
Outcome results
None listed