Allogeneic Transplantation (Non T-cell Depleted) Clinical Trial
Official title:
Phase I - Clinical Trial to Assess Safety of Ultraviolet (UV) Phototherapy for the Prevention of Graft Versus Host Disease After Allogeneic Stem Cell Transplantation
The primary goal of thos study is to assess safety of Ultraviolet (UV) Phototherapy for the
Prevention of Graft versus Host Disease after allogeneic stem cell transplantation (Phase I
- Clinical trial). Following allogeneic BMT, patients will be placed on standard GVHD
preventive therapy (cyclosporine).
Secondary goals -
- monitoring immune system recovery
- the influence of stem cells origin on therapy and/orGVHD prevention
- the influence of UV-c treatment on survival
clinical data and samples will be collected, during UV-c therapy, 100 days after discharge &
6 months after discharge - to examine the long-term effect of UV-c treatment on the
patient's GVHD status.
Treatment will be given with a portable, easy to operate device named "EUMATRON". this device contains a UV- lamp. 250 cc of blood from a peripheric vein is going through the device into a bottle with Low dose Heparin and returning to patient's body. procedure takes ~20 minutes. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention