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Trial record 98 of 799 for:    Interventional Studies | mesenchymal

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

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ClinicalTrials.gov Identifier: NCT02291770
Recruitment Status : Recruiting
First Posted : November 14, 2014
Last Update Posted : November 14, 2014
Sponsor:
Collaborators:
Sun Yat-sen University
Nanfang Hospital of 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
Information provided by (Responsible Party):
Guangdong General Hospital

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.

Condition or disease Intervention/treatment Phase
Chronic Graft-Versus-Host Disease Biological: Mesenchymal Stromal Cells Phase 3

Study Type : Interventional
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2014
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : December 2019


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 Name: 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.



Primary Outcome Measures :
  1. Proportion of patients responding to treatment of cGvHD with MSC [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 2 year ]
  2. Progression-free survival [ Time Frame: 2 year ]
  3. Time without systemic immunosuppression [ Time Frame: 2 year ]
  4. Cumulative incidents of non-relapse mortality [ Time Frame: 2 year ]
  5. Adverse events [ Time Frame: 2 year ]

Other Outcome Measures:
  1. Quality of life [ Time Frame: 2 year ]
  2. Immune reconstitution including monitoring of absolute T-cell subsets, B-cells, NK-cells as well as biomarkers of cGvHD [ Time Frame: 2 year ]


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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291770


Contacts
Contact: Xin Du, Prof. +86 02083827812-62122 miyadu@hotmail.com
Contact: Jianyu Weng, Prof. +86 02083827812-62122 wengjianyu1969@163.com

Locations
China, Guangdong
Xin Du Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Xin Du, Prof.       miaydu@hotmail.com   
Contact: Peilong Lai, Dr.    +86 02083827812-62121    lai_peilong@163.com   
Sponsors and Collaborators
Guangdong General Hospital
Sun Yat-sen University
Nanfang Hospital of 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
Investigators
Principal Investigator: Xin Du, Prof. Guangdong General Hospital

Publications:
Responsible Party: Guangdong General Hospital
ClinicalTrials.gov Identifier: NCT02291770     History of Changes
Other Study ID Numbers: No.GRDEC 2014210H
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: November 2014

Keywords provided by Guangdong General Hospital:
Chronic Graft-Versus-Host Disease
Mesenchymal Stromal Cells

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Prednisone
Mycophenolic Acid
Tacrolimus
Cyclosporins
Cyclosporine
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents