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Treatment of Chronic Graft-Versus-Host Disease With Mesenchymal Stromal Cells (MSC-cGvHD)

Primary Purpose

Chronic Graft-Versus-Host Disease

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Mesenchymal Stromal Cells
Sponsored by
Guangdong Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Graft-Versus-Host Disease focused on measuring Chronic Graft-Versus-Host Disease, Mesenchymal Stromal Cells

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Xin DuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Mesenchymal stem cells (MSC)

Placebo

Arm Description

Patients with newly diagnosed cGvHD receive primary treatment plus MSC: MSC+prednisone+cyclosporine; MSC+prednisone+tacrolimus; MSC+prednisone+mycophenolate mofetil.

Patients with newly diagnosed cGvHD receive primary treatment: Placebo+prednisone+cyclosporine; Placebo+prednisone+tacrolimus; Placebo+prednisone+mycophenolate mofetil.

Outcomes

Primary Outcome Measures

Proportion of patients responding to treatment of cGvHD with MSC

Secondary Outcome Measures

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

Full Information

First Posted
November 5, 2014
Last Updated
November 11, 2014
Sponsor
Guangdong Provincial People's Hospital
Collaborators
Sun Yat-sen University, Nanfang Hospital, Southern Medical University, Guangzhou General Hospital of Guangzhou Military Command, Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou First People's Hospital, Academy Military Medical Science, China
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1. Study Identification

Unique Protocol Identification Number
NCT02291770
Brief Title
Treatment of Chronic Graft-Versus-Host Disease With Mesenchymal Stromal Cells
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangdong Provincial People's Hospital
Collaborators
Sun Yat-sen University, Nanfang Hospital, Southern Medical University, Guangzhou General Hospital of Guangzhou Military Command, Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou First People's Hospital, Academy Military Medical Science, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Graft-Versus-Host Disease
Keywords
Chronic Graft-Versus-Host Disease, Mesenchymal Stromal Cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mesenchymal stem cells (MSC)
Arm Type
Active Comparator
Arm Description
Patients with newly diagnosed cGvHD receive primary treatment plus MSC: MSC+prednisone+cyclosporine; MSC+prednisone+tacrolimus; MSC+prednisone+mycophenolate mofetil.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients with newly diagnosed cGvHD receive primary treatment: Placebo+prednisone+cyclosporine; Placebo+prednisone+tacrolimus; Placebo+prednisone+mycophenolate mofetil.
Intervention Type
Biological
Intervention Name(s)
Mesenchymal Stromal Cells
Other Intervention Name(s)
MSC
Intervention Description
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).
Primary Outcome Measure Information:
Title
Proportion of patients responding to treatment of cGvHD with MSC
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
2 year
Title
Progression-free survival
Time Frame
2 year
Title
Time without systemic immunosuppression
Time Frame
2 year
Title
Cumulative incidents of non-relapse mortality
Time Frame
2 year
Title
Adverse events
Time Frame
2 year
Other Pre-specified Outcome Measures:
Title
Quality of life
Time Frame
2 year
Title
Immune reconstitution including monitoring of absolute T-cell subsets, B-cells, NK-cells as well as biomarkers of cGvHD
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Du, Prof.
Phone
+86 02083827812-62122
Email
miyadu@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jianyu Weng, Prof.
Phone
+86 02083827812-62122
Email
wengjianyu1969@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin Du, Prof.
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xin Du
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Du, Prof.
Email
miaydu@hotmail.com
First Name & Middle Initial & Last Name & Degree
Peilong Lai, Dr.
Phone
+86 02083827812-62121
Email
lai_peilong@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
23070118
Citation
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.
Results Reference
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PubMed Identifier
20818445
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.
Results Reference
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Treatment of Chronic Graft-Versus-Host Disease With Mesenchymal Stromal Cells

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