NCT03631589

Brief Summary

Steroid-resistant acute graft-versus-host disease (aGVHD) is one of the most severe complications in the setting of allogeneic hematopoietic stem cell transplantation (HSCT), which cannot be significant benefit from the second-line therapies.The mesenchymal stem cells (MSCs) possess extensive immunomodulatory properties and are very promising to rescue the refractory aGVHD.This study aims to assess the efficacy and safety of MSCs for the treatment of the refractory aGVHD.

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
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2017

Typical duration for phase_2

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

Study Start

First participant enrolled

December 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

2 years

First QC Date

August 13, 2018

Last Update Submit

August 13, 2018

Conditions

Steroid-resistant Severe aGVHD

Outcome Measures

Primary Outcomes (1)

  • complete and partial response rate

    1 year

Secondary Outcomes (1)

  • Adverse events that are related to treatment

    1 year

Study Arms (1)

MSCs treated

EXPERIMENTAL
Biological: MSCs

Interventions

MSCsBIOLOGICAL

mesenchymal stem cells therapy

MSCs treated

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Signed written informed consent
  • Aged \<65 years
  • Patients with steroid-resistant severe aGVHD
  • Cardiac: Left ventricular ejection fraction ≥ 50%
  • Adequate renal and hepatic function
  • Performance status: Karnofsky ≥ 70%

You may not qualify if:

  • Pregnant or lactating females.
  • Any co-morbidity precluding the administration of MSCs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

Central Study Contacts

Jianda Hu, Prof.M.D.Ph.D

CONTACT

86-13959169016drjiandahu@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the department of Hematology

Study Record Dates

First Submitted

August 13, 2018

First Posted

August 15, 2018

Study Start

December 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2021

Last Updated

August 15, 2018

Record last verified: 2018-08

Locations

CN(1)