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

Hadassah Medical Center

Status and phase: Withdrawn; Phase 1

Conditions: Allogeneic Transplantation (Non T-cell Depleted)

Treatments: Device: EUMATRON - EN 600 NT

Study type: Interventional

Funder types: Other

Identifiers

NCT00524953

UV-GVHD - HMO-CTIL

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 14 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

I

Experimental group

Description:

10 patients after allogeneic BMT (non T-depleted).

Treatment:

Device: EUMATRON - EN 600 NT