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

Chronic Graft-Versus-Host Disease Clinical Trial

— MSC-cGvHD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02291770
• Other study ID #: No.GRDEC 2014210H
• Status: Recruiting
• Phase: Phase 3
• First received: November 5, 2014
• Last updated: November 11, 2014
• Start date: October 2014
• Est. completion date: December 2019

Study information

• Verified date: November 2014
• Source: Guangdong General Hospital
• Contact: Xin Du, Prof.
• Phone: +86 02083827812-62122
• Email: miyadu[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 2019
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Graft-Versus-Host Disease
• Graft vs Host Disease

Intervention

Biological:
• Mesenchymal 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).

Locations

Country	Name	City	State
China	Xin Du	Guangzhou	Guangdong

Sponsors (7)

Lead Sponsor	Collaborator
Guangdong General Hospital	Academy Military Medical Science, China, Guangzhou First Municipal People’s Hospital, Guangzhou General Hospital of Guangzhou Military Command, Nanfang Hospital of Southern Medical University, Sun Yat-sen University, Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (2)

Weng J, He C, Lai P, Luo C, Guo R, Wu S, Geng S, Xiangpeng A, Liu X, Du X. Mesenchymal stromal cells treatment attenuates dry eye in patients with chronic graft-versus-host disease. Mol Ther. 2012 Dec;20(12):2347-54. doi: 10.1038/mt.2012.208. Epub 2012 Oct 16. — View Citation

Weng JY, Du X, Geng SX, Peng YW, Wang Z, Lu ZS, Wu SJ, Luo CW, Guo R, Ling W, Deng CX, Liao PJ, Xiang AP. Mesenchymal stem cell as salvage treatment for refractory chronic GVHD. Bone Marrow Transplant. 2010 Dec;45(12):1732-40. doi: 10.1038/bmt.2010.195. Epub 2010 Sep 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life		2 year	No
Other	Immune reconstitution including monitoring of absolute T-cell subsets, B-cells, NK-cells as well as biomarkers of cGvHD		2 year	No
Primary	Proportion of patients responding to treatment of cGvHD with MSC		90 days	No
Secondary	Overall survival		2 year	Yes
Secondary	Progression-free survival		2 year	Yes
Secondary	Time without systemic immunosuppression		2 year	No
Secondary	Cumulative incidents of non-relapse mortality		2 year	Yes
Secondary	Adverse events		2 year	Yes