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

Treatment of of Chronic Graft-Versus-Host Disease With Mesenchymal Stromal Cells. A Phase III Randomized Open Label Multi-center Study in Southern China.

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02291770

Acronym

MSC-cGvHD

Enrollment

130

Registered

2014-11-14

Start date

2014-10-31

Completion date

2019-12-31

Last updated

2014-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Graft-Versus-Host Disease

Keywords

Chronic Graft-Versus-Host Disease, Mesenchymal Stromal Cells

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.

Interventions

BIOLOGICALMesenchymal Stromal Cells

Mesenchymal stem cell(MSC). Patients with newly diagnosed cGvHD: prednisone 1mg/kg + cyclosporine or tacrolimus and MSC 2×1,000,000 MSC/kg, IV twice a week for the first two weeks and weekly for the following two weeks(6 doses totally).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

14 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Proportion of patients responding to treatment of cGvHD with MSC	90 days

Secondary

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

Other

Measure	Time frame
Quality of life	2 year
Immune reconstitution including monitoring of absolute T-cell subsets, B-cells, NK-cells as well as biomarkers of cGvHD	2 year

Countries

China

Contacts

Primary ContactXin Du, Prof.

miyadu@hotmail.com+86 02083827812-62122

Backup ContactJianyu Weng, Prof.

wengjianyu1969@163.com+86 02083827812-62122

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026