Treatment of Chronic Graft-Versus-Host Disease With Mesenchymal Stromal Cells

Phase 3

• Conditions: Chronic Graft-Versus-Host Disease

• Registration Number: NCT02291770
• Lead Sponsor: Guangdong Provincial People's Hospital

Brief Summary

Chronic Graft-versus-Host Disease (cGvHD) is a potentially lethal disorder. A variety of second line immunosuppressive agents have been investigated but no optimal treatment has emerged. There is therefore a need for novel treatment strategies. Mesenchymal stromal cells (MSC) exhibit immunomodulatory properties and a recent pilot study suggests a response rate of 70% in steroid- refractory patients. In the present randomized study the efficacy and safety of MSC treatment will be further studied in patients with cGvHD.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Status Verified: 2014-11
• Study First Submitted: 2014-11-05
• Study First Submitted QC: 2014-11-11
• Last Update Submitted: 2014-11-11
• Study First Posted: 2014-11-14
• Last Update Posted: 2014-11-14
• Primary Completion: 2015-11
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Newly diagnosed cGvHD
• Informed consent obtained from patient and donor.
• Any patient who has undergone allogeneic stem cell transplantation with c GvHD.
• Have not received additional agent for cGVHD within 3 months.
• Expected life is more than 90 days.
• Adequate pulmonary function with no evidence of chronic obstructive or severe restrictive pulmonary disease.
• Adequate cardiac function with no evidence of uncontrolled high blood pressure,congestive heart failure, angina pectoris, acute myocardial infarction within 6 months prior to the process.

Exclusion Criteria

• Invasive fungal disease.
• Active cytomegalovirus (CMV)/Epstein-Barr virus(EBV)/varicella disease).
• Patient is with a history of hypersensitivity to bovine products.
• Relapsed malignancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of patients responding to treatment of cGvHD with MSC	90 days

Secondary Outcome Measures

Name	Time	Method
Overall survival	2 year
Adverse events	2 year
Progression-free survival	2 year
Cumulative incidents of non-relapse mortality	2 year
Time without systemic immunosuppression	2 year

Trial Locations

Locations (1)

Xin Du; 🇨🇳 Guangzhou, Guangdong, China