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

January 29, 2020 updated by: Ting YANG, Fujian Medical University

Co-transplantation of Mesenchymal Stromal Cells in Allogeneic Hematopoietic Stem Cell Transplantation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Union Hospital,Fujian Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ting Yang, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: HSC
Experimental: MSC+HSC
Biological: Cotransplant with MSCs
Co-transplantation of MSCs during allogeneic HSCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival Rate
Time Frame: up to 2 years after HSCT
up to 2 years after HSCT

Secondary Outcome Measures

Outcome Measure
Time Frame
Cumulative Incidence of Graft-versus Host Disease
Time Frame: up to 2 years after HSCT
up to 2 years after HSCT
Incidence of Systemic Infections
Time Frame: up to 2 years after HSCT
up to 2 years after HSCT
Mean Time to Engraftment
Time Frame: Baseline to engraftment, assessed minimally 28 days post transplant
Baseline to engraftment, assessed minimally 28 days post transplant
Transplant-Related Mortality
Time Frame: up to 1 months after HSCT
up to 1 months after HSCT
Rates of Relapse
Time Frame: up to 2 years after HSCT
up to 2 years after HSCT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2020

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

January 28, 2020

First Submitted That Met QC Criteria

January 29, 2020

First Posted (Actual)

January 30, 2020

Study Record Updates

Last Update Posted (Actual)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 29, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • MSC-SCT-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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