Graft vs Host Disease
Conditions
Keywords
Stem Cell Transplantation, Decidual Stromal Cells
Brief summary
The purpose of this study is to evaluate the 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 1x10\^6 cells/kg at one or more occasions at weekly intervals dependent on clinical response.
Interventions
BIOLOGICALEarly Decidual stromal cell therapy
Intervention given within 7 days after corticosteroids.
BIOLOGICALLate Decidual stromal cell therapy
Intervention given after 7 days after corticosteroids.
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 or therapy resistant chronic graft versus host disease. * Are on calcineurin inhibitor and high dose corticosteroids.
Exclusion criteria
* Terminally ill patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Actuarial survival at one year after onset of graft versus host disease | 12 months after inclusion |
Secondary
| Measure | Time frame |
|---|---|
| Response at 28 days after onset of graft versus host disease | 28 days after inclusion |
| Side effects | Up to 6 months after inclusion |
| Incidence of severe infections | Up to 12 months after inclusion |
| Disease free survival | 12 months after inclusion |
Countries
Sweden
Contacts
Primary ContactOlle Ringdén, MD, PhD
Backup ContactHelen Kaipe, PhD
Outcome results
None listed