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

Phase 1

Withdrawn

• Conditions: Allogeneic Transplantation (Non T-cell Depleted)
• Interventions: Device: EUMATRON - EN 600 NT

• Registration Number: NCT00524953
• Lead Sponsor: Hadassah Medical Organization

Brief 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.

Study Timeline

• Status Verified: 2007-08
• Study Start: 2007-09
• Study First Submitted: 2007-09-04
• Study First Submitted QC: 2007-09-04
• Study First Posted: 2007-09-05
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Last Update Submitted: 2015-06-10
• Last Update Posted: 2015-06-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• patients post non T cell depleted allogeneic stem cell transplantation

Exclusion Criteria

• morbidity unrelated to GVHD
• patients in an hemodynamic unstable condition
• acute uncontrolled bleeding
• patients undergoing dialysis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
I	EUMATRON - EN 600 NT	10 patients after allogeneic BMT (non T-depleted).

Primary Outcome Measures

Name	Time	Method
safety and tolerability of UV-c phototherapy for the Prevention of Graft versus Host Disease after allogeneic stem cell transplantation	6 months

Secondary Outcome Measures

Name	Time	Method
monitoring immune system recovery, influence on survival rates, influence of stem cells origin on treatment & prevention of GVHD	100 days, 6 months

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel