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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Information provided by:
Hadassah Medical Organization Identifier:
First received: September 4, 2007
Last updated: August 18, 2008
Last verified: August 2007

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.

Condition Intervention Phase
Allogeneic Transplantation (Non T-Cell Depleted)
Device: EUMATRON - EN 600 NT
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • safety and tolerability of UV-c phototherapy for the Prevention of Graft versus Host Disease after allogeneic stem cell transplantation [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • monitoring immune system recovery, influence on survival rates, influence of stem cells origin on treatment & prevention of GVHD [ Time Frame: 100 days, 6 months ]

Estimated Enrollment: 10
Study Start Date: September 2007
Estimated Study Completion Date: September 2008
Arms Assigned Interventions
Experimental: I
10 patients after allogeneic BMT (non T-depleted).
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)
Other Name: EN 600 NT

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.


Ages Eligible for Study:   14 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00524953

Contact: Reuven Or, MD 972-2-6778357

Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD    00 972 2 6776095   
Contact: Hadas Lemberg, PhD    00 972 2 6777572   
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Reuven Or, MD Bone Marrow transplantation, cancer immunotherapy & immunobiology research center, Hadassah University Hospital, Ein - Kerem, Jerusalem, Israel
  More Information

No publications provided Identifier: NCT00524953     History of Changes
Other Study ID Numbers: UV-GVHD - HMO-CTIL
Study First Received: September 4, 2007
Last Updated: August 18, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
allogeneic bone marrow transplantation
non-T-cell depleted
GVHD processed this record on March 26, 2015