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A Phase 1/2 Trial of Donor Regulatory T-cells for Steroid-Refractory Chronic Graft-versus-Host-Disease

NCT02385019 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2018-03-06

No results posted yet for this study

Summary

Phase 1/2 clinical study for the treatment of steroid-refractory chronic graft versus host disease after an allogeneic transplant of hematopoietic progenitors with donor CliniMACS-selected regulatory T cells

Conditions

  • Graft vs Host Disease

Interventions

BIOLOGICAL

Donor regulatory T cell adoptive immunotherapy in chronic graft versus host disease

Regulatory T cells selected by a sequential 2 step procedure: 1. \- Negative selection of CD8 and CD19 cells 2. \- Positive selection of CD25 cells

Sponsors & Collaborators

  • Hospital de Santa Maria, Portugal

    collaborator OTHER

  • IPOFG Lisboa, Portugal

    collaborator UNKNOWN

  • IPOFG Porto, Portugal

    collaborator UNKNOWN

  • Instituto de Medicina Molecular João Lobo Antunes

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2019-03-31
Completion
2019-12-31

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02385019 on ClinicalTrials.gov