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Donor Regulatory T-cells for Steroid-Refractory Chronic Graft-versus-host-Disease

NCT03683498 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-05-23

No results posted yet for this study

Summary

A Phase I Trial of Donor Regulatory T-cells for Steroid-Refractory Chronic Graft-versus-Host-Disease in patients who do not obtain complete remission with ruxolitinib

Conditions

  • Chronic Graft vs Host Disease

Interventions

BIOLOGICAL

Regulatory T-cell enriched infusion

Enrichment of CD25hi regulatory T cells from CD8 and/or CD19 pre-depleted leukapheresis products.

Sponsors & Collaborators

  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    lead OTHER

Principal Investigators

  • José Antonio Pérez-Simón, M.D. Ph.D. · Department of Hematology, Hospital Universitario Virgen del Rocío, Sevilla.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-25
Primary Completion
2022-03-24
Completion
2022-03-24

Countries

  • Spain

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 NCT03683498 on ClinicalTrials.gov