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

November 11, 2014 updated by: Guangdong Provincial People's Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mesenchymal stem cells (MSC)

Patients with newly diagnosed cGvHD receive primary treatment plus MSC:

  1. MSC+prednisone+cyclosporine;
  2. MSC+prednisone+tacrolimus;
  3. MSC+prednisone+mycophenolate mofetil.
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).
Other Names:
  • MSC
Placebo Comparator: Placebo

Patients with newly diagnosed cGvHD receive primary treatment:

  1. Placebo+prednisone+cyclosporine;
  2. Placebo+prednisone+tacrolimus;
  3. Placebo+prednisone+mycophenolate mofetil.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients responding to treatment of cGvHD with MSC
Time Frame: 90 days
90 days

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Collaborators

Sun Yat-sen University
Guangzhou First People's Hospital
Nanfang Hospital of Southern Medical University
Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou General Hospital of Guangzhou Military Command
Academy Military Medical Science, China

Investigators

  • Principal Investigator: Xin Du, Prof., Guangdong Provincial People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

November 1, 2015

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

November 5, 2014

First Submitted That Met QC Criteria

November 11, 2014

First Posted (Estimate)

November 14, 2014

Study Record Updates

Last Update Posted (Estimate)

November 14, 2014

Last Update Submitted That Met QC Criteria

November 11, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No.GRDEC 2014210H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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