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MSC for Treatment of cGVHD After Allo-HSCT

NCT04692376 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2020-12-31

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy of mesenchymal stem cells in patients with chronic graft-versus-host disease.

Conditions

  • Chronic Graft-versus-host Disease

Interventions

BIOLOGICAL

Mesenchymal stem cells

Mesenchymal stem cells (MSCs) will be intravenously infused via a central venous catheter(at a dose of 1×10\^6 cells/kg, over 15 mins) weekly. MSCs will be administrated for 8 doses.

DRUG

Glucocorticoids

Glucocorticoids (i.e. Methylprednisolone) will be used with an initial dose of 1mg/kg.

DRUG

cyclosporine

Cyclosporine (CsA) will be used with an initial dose of 2.5mg/kg/d and adjusted according to the concentration of CsA. The targeted concentration is 200-300 ng/Ml.

Sponsors & Collaborators

  • Sun Yat-sen University

    collaborator OTHER

  • Army Medical University, China

    collaborator OTHER

  • Peking University People's Hospital

    collaborator OTHER

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Qi-fa Liu, MD · Nanfang Hospital, Southern Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-01-10
Primary Completion
2022-12-31
Completion
2023-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT04692376 on ClinicalTrials.gov