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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Chinese Academy of Medical Sciences.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Zhejiang University
Chinese PLA General Hospital
307 Hospital of PLA
Peking Union Medical College
Information provided by (Responsible Party):
Robert Chunhua Zhao, MD, PhD, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01526850
First received: February 1, 2012
Last updated: August 1, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Chronic Graft Versus Host Disease
Biological: Biological: mesenchymal stem cell
Drug: Cyclosporine and Glucocorticoid
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • The total Response rate defined as patients with complete and partial response [ Time Frame: 1 year after MSCs administration. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • one-year survival rate [ Time Frame: 1 year after MSCs administration ] [ Designated as safety issue: Yes ]
  • disease relapse [ Time Frame: 2 years after MSCs administration ] [ Designated as safety issue: Yes ]
  • quality of life [ Time Frame: 2 years after MSCs administration ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: February 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Calmodulin inhibitors combined with Glucocorticoid

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.

  Eligibility

Ages Eligible for Study:   2 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526850

Contacts
Contact: He Huang, MD 86-0571-87236706 hehuangyu@126.com

Locations
China, Zhejiang
Zhejiang University Recruiting
Hangzhou, Zhejiang, China
Contact: He Huang, MD    86-0571-87236706    hehuangyu@126.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Zhejiang University
Chinese PLA General Hospital
307 Hospital of PLA
Peking Union Medical College
Investigators
Principal Investigator: He Huang, MD Zhejiang University
Principal Investigator: Chunhua Zhao, MD,PHD Peking Union Medical College
  More Information

Publications:

Responsible Party: Robert Chunhua Zhao, MD, PhD, MD, PhD,Professor of medicine, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01526850     History of Changes
Other Study ID Numbers: D07050701350701
Study First Received: February 1, 2012
Last Updated: August 1, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Chinese Academy of Medical Sciences:
cGVHD

Additional relevant MeSH terms:
Glucocorticoids
Graft vs Host Disease
Immune System Diseases
Cyclosporine
Cyclosporins
Anti-Infective Agents
Antifungal Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014