Treatment of severe gastrointestinal graft-versus-host disease with regulatory T cells

Phase 1

• Conditions: Steroid resistant severe acute gastrointestinal graft-versus-host disease; MedDRA version: 20.0Level: LLTClassification code 10068908Term: AGVHDSystem Organ Class: 100000004870; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2012-002685-12-DE
• Lead Sponsor: niversity Hospital Regensburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-29
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

- Histology-proven GVHD
- Clinical stage 2-4 acute gastrointestinal GVHD with or without other GVHD manifestations (overall GVHD grade III-IV)
- Disease resistance to steroid treatment (at least 1 mg/kg bw) - Male and female patients, age 18 - 70y
- Written informed consent of patient
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 29
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 29

Exclusion Criteria

- Age <18 y and >70 y
- No previous steroid therapy (first-line treatment)
- No previous second-line therapy
- Severe psychiatric disorders
- Presumed life expectancy < 4 wks
- Lack of informed consent
- Pregnant or nursing woman
- Patients included in other clinical trials interfering with the present study
- Donors from outside EU

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified