Ex-vivo Expanded Donor Regulatory T Cells for Prevention of Acute Graft-Versus-Host Disease

NCT01795573 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2022-11-03

No results posted yet for this study

Summary

Clinical trial of allospecific regulatory t cells (Tregs) for prevention of acute graft-versus-host disease (GVHD) in human leukocyte antigen (HLA) identical sibling transplants.

Conditions

Interventions

BIOLOGICAL

Cultured Treg cells

Co-culturing of recipient dendritic cells and donor Treg. Treg administration will occur 2 days before the allogeneic stem cell transplant (i.e. day -2 with reference of day 0 as stem cell infusion date).

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Joseph Pidala, MD, PhD · Moffitt Cancer Center

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-29
Primary Completion
2020-08-14
Completion
2020-08-14

Countries

  • United States

Study Locations

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Entities

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 NCT01795573 on ClinicalTrials.gov