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Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00524953

Enrollment

Registered

2007-09-05

Start date

2007-09-30

Completion date

2013-09-30

Last updated

2015-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allogeneic Transplantation (Non T-cell Depleted)

Keywords

allogeneic bone marrow transplantation, non-T-cell depleted, UV-c, GVHD

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.

Interventions

DEVICEEUMATRON - 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)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

14 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026