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Efficacy and Safety of UC-MSCs for the Treatment of Steroid-resistant aGVHD Following Allo-HSCT

NCT04738981 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2023-06-01

No results posted yet for this study

Summary

Randomized, open-label, multicenter study to investigate the efficacy and safety of umbilical cord-derived mesenchymal stem cells (UC-MSC) for the treatment of steroid-resistant acute graft-versus-host disease (aGVHD) following allogeneic hematopoietic stem cell transplantation (allo-HSCT), with a view to establishing an effective treatment protocol for steroid-resistant aGVHD.

Conditions

  • Graft Vs Host Disease

Interventions

DRUG

UC-MSC

UC-MSC, iv, 1×10\^6 cells/kg, once a week, for 4 weeks.

DRUG

Anti-CD25 mAb

Anti-CD25 mAb, iv, 20mg，twice in first week and once a week thereafter, for 4 weeks.

Sponsors & Collaborators

  • Southern Medical University, China

    collaborator OTHER

  • Third Military Medical University

    collaborator OTHER

  • Sun Yat-sen University

    collaborator OTHER

  • Peking University People's Hospital

    lead OTHER

Principal Investigators

  • Xiaohui Zhang, doctor · Peking University People's Hospital, Peking University Insititute of Hematology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2022-05-30
Completion
2023-05-02

Countries

  • China

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 NCT04738981 on ClinicalTrials.gov