NCT04247945

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.

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
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2020

Longer than P75 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

First Submitted

Initial submission to the registry

January 28, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

3.8 years

First QC Date

January 28, 2020

Last Update Submit

January 29, 2020

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

  • Survival Rate

    up to 2 years after HSCT

Secondary Outcomes (5)

  • 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

    Baseline to engraftment, assessed minimally 28 days post transplant

  • Transplant-Related Mortality

    up to 1 months after HSCT

  • Rates of Relapse

    up to 2 years after HSCT

Study Arms (2)

HSC

NO INTERVENTION

MSC+HSC

EXPERIMENTAL
Biological: Cotransplant with MSCs

Interventions

Cotransplant with MSCsBIOLOGICAL

Co-transplantation of MSCs during allogeneic HSCT

MSC+HSC

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
  • Willing to transplant
  • 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)

Union Hospital,Fujian Medical University

Fuzhou, Fujian, 350001, China

RECRUITING

Central Study Contacts

Ting Yang, Prof.

CONTACT

+86-591-86218041yang.hopeting@gmail.com

Study Design

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

Study Record Dates

First Submitted

January 28, 2020

First Posted

January 30, 2020

Study Start

February 1, 2020

Primary Completion

December 1, 2023

Study Completion

December 1, 2025

Last Updated

January 30, 2020

Record last verified: 2020-01

Locations

CN(1)