MSC for Severe aGVHD

Phase 2

• Conditions: Steroid-resistant Severe aGVHD

• Registration Number: NCT03631589
• Lead Sponsor: Fujian Medical University

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 available

Study Timeline

• Study Start: 2017-12-01
• Status Verified: 2018-08
• Study First Submitted: 2018-08-13
• Study First Submitted QC: 2018-08-13
• Last Update Submitted: 2018-08-13
• Study First Posted: 2018-08-15
• Last Update Posted: 2018-08-15
• Primary Completion: 2019-12-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
complete and partial response rate	1 year

Secondary Outcome Measures

Name	Time	Method
Adverse events that are related to treatment	1 year

Trial Locations

Locations (1)

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