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


Phase 1
14 Years
70 Years
Not Enrolling
Both
Allogeneic Transplantation (Non T-Cell Depleted)

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

6 months

Principal Investigator

Reuven Or, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Bone Marrow transplantation, cancer immunotherapy & immunobiology research center, Hadassah University Hospital, Ein - Kerem, Jerusalem, Israel

Authority:

Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:

UV-GVHD - HMO-CTIL

NCT ID:

NCT00524953

Start Date:

September 2007

Completion Date:

September 2008

Related Keywords:

  • Allogeneic Transplantation (Non T-Cell Depleted)
  • allogeneic bone marrow transplantation
  • non-T-cell depleted
  • UV-c
  • GVHD
  • Graft vs Host Disease

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