Efficacy and Safety Study of Allogenic Mesenchymal Stem Cells for Patients With Chronic Graft Versus Host Disease (MSCsTcGVHD)

August 1, 2012 updated by: Robert Chunhua Zhao, MD, PhD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Phase Ⅱ/Ⅲ Clinical Trial, Multicenter, Randomized, Controlled, for the Evaluation of Efficacy and Safety of Therapy With Allogenic Mesenchymal Stem Cells in Patients With Chronic Graft Versus Host Disease

The primary purpose of the study is to evaluate the safety and efficacy of mesenchymal stem cells (MSC) for the treatment of patients who have developed an extensive chronic graft versus host disease (with skin and/or liver damage) after HSCs transplantation and do not respond to first-line therapy.

The secondary purpose of the study is to evaluate the effect of mesenchymal stem cells (MSC) on one-year survival rate, long-term survival rate, life quality and recurrence of patients who have developed an extensive chronic graft versus host disease (with skin and/or liver damage) after HSCs transplantation and do not respond to hormone treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Chronic Graft-versus-host disease (GVHD)， with the incidence of 30%-60%, is a serious late complication of allogeneic hematopoietic stem cell transplantation (HSCT) and is the major cause of death in the late stage of transplantation. According to targeted organs, cGVHD is divided into two types, limited cGVHD and extensive cGVHD. Extensive cGVHD needs systemic immunosuppressant treatment. However, currently standard first-line regimen including cyclophosphamide and prednisolone is only effective for some patients. Novel treatment is urgently needed. Our previous study has shown that mesenchymal stem cells (MSCs) are effective for cGVHD patients with multiple skin damage. To further explore the therapeutic effect of MSCs for extensive cGVHD, we plan to conduct a multi-center clinical trial. Patients who developed an extensive cGVHD (with skin and/or liver damage) after HSCs transplantation and do not respond to first-line therapy are enrolled. They will be randomly divided into two groups which will receive MSCs and routine second-line drugs respectively. We will evaluate the efficacy and safety of MSCs for extensive cGVHD by comparison of symptom improvement, survival rate, recurrence as well as side effects in the two groups.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • 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 Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang University
        • Contact:

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

2 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Extensive cGVHD with skin and/or liver damage developed after allogeneic hematopoietic stem cell transplantation
  • cGVHD that do not response to conventional immunosuppressant treatment for two months
  • KPS>= 30
  • informed consent from the patient

Exclusion Criteria:

  • Extensive cGVHD without skin or liver damage
  • With other acute severe complications
  • In pregnancy or lactation
  • Disease relapses
  • With non-hematological malignancy
  • Have a history of mental disorder, drug or alcohol abuse over the past five years
  • Allergic
  • Participate in other clinical trial within three months before the start of this trial
  • With bone marrow fibrosis
  • Have undergone hematopoietic stem cell transplantation to treat solid tumor

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
Experimental: allogenic mesenchymal stem cells (MSCs)
patients who have developed an extensive chronic graft versus host disease (with skin and/or liver damage) after HSCs transplantation and do not respond to standard first-line regimen including cyclophosphamide and prednisolone.
Biological: Biological: mesenchymal stem cell
Mesenchymal stem cells, 1-2×107, bone marrow injection, once a week for the first four weeks; whether to continue after four weeks depends on patients' symptoms.
Other Names:
  • Regenerative medicine: MSCs
Active Comparator: Control group
patients who have developed an extensive chronic graft versus host disease (with skin and/or liver damage) after HSCs transplantation and do not respond to standard first-line regimen including cyclophosphamide and prednisolone.
Drug: Cyclosporine and Glucocorticoid
Calmodulin inhibitors such as cyclosporine, combined with Glucocorticoid 0.5-1mg/kg/d ,to the end of the study.
Other Names:
  • Calmodulin inhibitors combined with Glucocorticoid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The total Response rate defined as patients with complete and partial response
Time Frame: 1 year after MSCs administration.
1 year after MSCs administration.

Secondary Outcome Measures

Outcome Measure
Time Frame
one-year survival rate
Time Frame: 1 year after MSCs administration
1 year after MSCs administration
disease relapse
Time Frame: 2 years after MSCs administration
2 years after MSCs administration
quality of life
Time Frame: 2 years after MSCs administration
2 years after MSCs administration

Collaborators and Investigators

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

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborators

307 Hospital of PLA
Chinese PLA General Hospital
Zhejiang University
Peking Union Medical College

Investigators

  • Principal Investigator: He Huang, MD, Zhejiang University
  • Principal Investigator: Chunhua Zhao, MD,PHD, Peking Union Medical College

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

February 1, 2012

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

February 1, 2012

First Submitted That Met QC Criteria

February 2, 2012

First Posted (Estimate)

February 6, 2012

Study Record Updates

Last Update Posted (Estimate)

August 3, 2012

Last Update Submitted That Met QC Criteria

August 1, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D07050701350701

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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