NCT04692376

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
152

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

January 10, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

December 31, 2020

Status Verified

December 1, 2020

Enrollment Period

2 years

First QC Date

December 26, 2020

Last Update Submit

December 29, 2020

Conditions

Chronic Graft-versus-host Disease

Keywords

Hematopoietic Stem Cell TransplantationChronic Graft-versus-host diseaseMesenchymal Stem Cells

Outcome Measures

Primary Outcomes (1)

  • ORR

    Overall response rate （ORR）includes complete response (CR) and part response (PR).

    12 weeks after the first dose of MSCs

Secondary Outcomes (6)

  • OS

    1 year after the first dose of MSCs

  • DFS

    1 year after the first dose of MSCs

  • Response rate

    4 weeks after the first dose of MSCs

  • EBV DNA-emia

    1 year after the first dose of MSCs

  • CMV DNA-emia

    1 year after the first dose of MSCs

  • +1 more secondary outcomes

Study Arms (2)

MSCs group

EXPERIMENTAL

MSCs group refers to treatment with mesenchymal stem cells (1×10\^6 cells/kg, intravenously) weekly for 8 doses. Besides, glucocorticoids and cyclosporine (CsA) will be used for treatment concurrently.

Biological: Mesenchymal stem cellsDrug: GlucocorticoidsDrug: cyclosporine

Control group

ACTIVE COMPARATOR

Glucocorticoids and CsA will be used for treatment.

Drug: GlucocorticoidsDrug: cyclosporine

Interventions

Mesenchymal stem cellsBIOLOGICAL

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.

MSCs group
GlucocorticoidsDRUG

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

Control groupMSCs group
cyclosporineDRUG

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.

Control groupMSCs group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A patient age of 18-65 years
  • Recipients of allogeneic hematopoietic stem cell transplantation Patients with moderate/ severe cGVHD without systemic treatment
  • Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

You may not qualify if:

  • Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
  • Primary disease relapse
  • Expected lifetime less than 3 months
  • Patients with any conditions not suitable for the trial (investigators' decision)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Interventions

GlucocorticoidsCyclosporine

Condition Hierarchy (Ancestors)

Organizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Intervention Hierarchy (Ancestors)

Adrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Qi-fa Liu, MD

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ren Lin, MD

CONTACT

+86-020-62787883lansinglinren@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 26, 2020

First Posted

December 31, 2020

Study Start

January 10, 2021

Primary Completion

December 31, 2022

Study Completion

June 30, 2023

Last Updated

December 31, 2020

Record last verified: 2020-12

Locations

CN(1)