NCT00524953

Phase I Clinical Trial to Assess Safety of UV Phototherapy for the Prevention of GVHD Post Allogeneic SCT

Phase I - Clinical Trial to Assess Safety of Ultraviolet (UV) Phototherapy for the Prevention of Graft Versus Host Disease After Allogeneic Stem Cell Transplantation

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: All
• Age: 14 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Allogeneic Transplantation (Non T-cell Depleted)

Interventions

Type	Name	Description
DEVICE	EUMATRON - EN 600 NT	frequency - once a week, starting 4 days after transplantation for four weeks (total of 4 treatments) each treatment will last \~20 minutes. In addition - standard GVHD preventive protocol will be given to patients (including cyclosporine and steroids - if necessary)

Timeline

• Start date: 2007-09-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2007-09-05
• Last updated: 2015-06-11

Locations

1 site across 1 country: Israel