Allogeneic Hematopoietic Cell Transplant, Myelodysplastic/Myeloproliferative Neoplasm, Steroid Refractory GVHD
Conditions
Brief summary
This is a single participant study of decidual stromal cells (DSC) for the treatment of steroid refractory graft-versus-host disease (GVHD) in a patient with myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN).
Interventions
BIOLOGICALDecidual stromal cells (DSC)
DSCs are isolated from donated human placenta and have been shown to have anti-inflammatory effects.
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A single participant with myelodysplastic syndrome/myeloproliferative neoplasm located at Princess Margaret Cancer Centre who experienced steroid-refractory graft-vs-host disease after receiving an allogeneic hematopoietic cell transplant and have no standard treatment options available.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eastern Cooperative Oncology Group Performance Status Score | 6 weeks | — |
| Karnofsky Performance Score | 6 weeks | — |
| Graft-Versus-Host Disease Severity | 6 weeks | By grade |
| Aspartate Transaminase levels | 6 weeks | — |
| Alanine aminotransferase levels | 6 weeks | — |
| Alkaline phosphatase levels | 6 weeks | — |
| Bilirubin levels | 6 weeks | — |
| C-reactive protein levels | 6 weeks | — |
Countries
Canada
Outcome results
None listed