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

This study has been withdrawn prior to enrollment.
Information provided by:
Hadassah Medical Organization Identifier:
First received: September 4, 2007
Last updated: June 10, 2015
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: 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 ]

Enrollment: 0
Study Start Date: September 2007
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
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   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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Please refer to this study by its identifier: NCT00524953

Hadassah Medical Organization
Jerusalem, Israel
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 Identifier: NCT00524953     History of Changes
Other Study ID Numbers: UV-GVHD - HMO-CTIL
Study First Received: September 4, 2007
Last Updated: June 10, 2015

Keywords provided by Hadassah Medical Organization:
allogeneic bone marrow transplantation
non-T-cell depleted
GVHD processed this record on May 22, 2017