Co-transplantation of MSC in the Setting of Allo-HSCT | NCT04247945

Studies
Co-transplantation of MSC in the Setting of Allo-HSCT

NCT04247945

Sponsor

Fujian Medical University

Status

Unknown status

Last Update Posted

Jan 30, 2020Actual

Enrollment

120Estimated

Phase

Phase 2Phase 3

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation

Interventions

Cotransplant with 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

Jan 2020

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

Feb 1, 2020Estimated

Primary Completion Date

Dec 1, 2023Estimated

Completion Date

Dec 1, 2025Estimated

First Submitted Date

Jan 28, 2020

First Submission Date that Met QC Criteria

Jan 29, 2020

First Posted Date

Jan 30, 2020Actual

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

Jan 29, 2020

Last Update Posted Date

Jan 30, 2020Actual

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

Mesenchymal stem cells (MSCs) are known to exhibit immunomodulatory, anti-inflammatory, and pro-angiogenic properties, and therefore have the potential to improve the outcome of allogeneic hematopoietic stem cell transplantation (allo-HSCT) .The study is aimed to identify and evaluate the potential benefits of MSCs infusion during allogeneic HSCT, with regard to the engraftment, graft versus host disease (GVHD), post-transplant relapse and survival.

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

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HSC	No Intervention
MSC+HSC	Experimental		Biological: Cotransplant with MSCs

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cotransplant with MSCs	Biological	Co-transplantation of MSCs during allogeneic HSCT	MSC+HSC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival Rate		up to 2 years after HSCT

Secondary Outcomes

Measure	Description	Time Frame
Cumulative Incidence of Graft-versus Host Disease		up to 2 years after HSCT
Incidence of Systemic Infections		up to 2 years after HSCT
Mean Time to Engraftment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed written informed consent
Aged <65 years
Willing to transplant
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
Ting Yang, Prof.	Contact	+86-591-86218041		yang.hopeting@gmail.com

Overall Officials

Not provided

Locations

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