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

Phase 2

Recruiting

• Conditions: Allogeneic Hematopoietic Stem Cell Transplantation

• Registration Number: NCT04247945
• Lead Sponsor: Fujian Medical University

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 available

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-28
• Study First Submitted QC: 2020-01-29
• Last Update Submitted: 2020-01-29
• Study First Posted: 2020-01-30
• Last Update Posted: 2020-01-30
• Study Start: 2020-02-01
• Primary Completion: 2023-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Survival Rate	up to 2 years after HSCT

Secondary Outcome Measures

Name	Time	Method
Rates of Relapse	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
Cumulative Incidence of Graft-versus Host Disease	up to 2 years after HSCT

Trial Locations

Locations (1)

Union Hospital,Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China