MSC for Severe aGVHD | NCT03631589

Studies
MSC for Severe aGVHD

NCT03631589

Sponsor

Fujian Medical University

Status

Unknown status

Last Update Posted

Aug 15, 2018Actual

Enrollment

50Estimated

Phase

Phase 2Phase 3

Conditions

Steroid-resistant Severe aGVHD

Interventions

MSCs

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2017Actual

Primary Completion Date

Dec 1, 2019Estimated

Completion Date

Dec 1, 2021Estimated

First Submitted Date

Aug 13, 2018

First Submission Date that Met QC Criteria

Aug 13, 2018

First Posted Date

Aug 15, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2018

Last Update Posted Date

Aug 15, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jianda Hu, Director of the department of Hematology, Fujian Medical UniversityPrincipal Investigator

Lead Sponsor

Fujian Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MSCs treated	Experimental		Biological: MSCs

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MSCs	Biological	mesenchymal stem cells therapy	MSCs treated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
complete and partial response rate		1 year

Secondary Outcomes

Measure	Description	Time Frame
Adverse events that are related to treatment		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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%

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jianda Hu, Prof.M.D.Ph.D	Contact	86-13959169016		drjiandahu@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fujian Medical University Union Hospital	Recruiting	Fuzhou	Fujian	350001	China