Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
152 participants
INTERVENTIONAL
2021-01-10
2023-06-30
Brief Summary
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Detailed Description
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Mesenchymal stem cells (MSCs) are a form of multipotent adult stem cells that can be isolated from bone marrow (BM), adipose tissue, and cord blood. Clinical applications of human MSCs are evolving rapidly with goals of improving hematopoietic engraftment, preventing and treating GVHD after allo-HSCT and so on. However, the efficacy of treatment of cGVHD remains undetermined.
In the present study, the investigators will prospectively evaluate the efficacy and safety of ex-vivo-expanded MSCs in treating patients with cGVHD.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MSCs group
MSCs group refers to treatment with mesenchymal stem cells (1×10\^6 cells/kg, intravenously) weekly for 8 doses. Besides, glucocorticoids and cyclosporine (CsA) will be used for treatment concurrently.
Mesenchymal stem cells
Mesenchymal stem cells (MSCs) will be intravenously infused via a central venous catheter(at a dose of 1×10\^6 cells/kg, over 15 mins) weekly. MSCs will be administrated for 8 doses.
Glucocorticoids
Glucocorticoids (i.e. Methylprednisolone) will be used with an initial dose of 1mg/kg.
cyclosporine
Cyclosporine (CsA) will be used with an initial dose of 2.5mg/kg/d and adjusted according to the concentration of CsA. The targeted concentration is 200-300 ng/Ml.
Control group
Glucocorticoids and CsA will be used for treatment.
Glucocorticoids
Glucocorticoids (i.e. Methylprednisolone) will be used with an initial dose of 1mg/kg.
cyclosporine
Cyclosporine (CsA) will be used with an initial dose of 2.5mg/kg/d and adjusted according to the concentration of CsA. The targeted concentration is 200-300 ng/Ml.
Interventions
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Mesenchymal stem cells
Mesenchymal stem cells (MSCs) will be intravenously infused via a central venous catheter(at a dose of 1×10\^6 cells/kg, over 15 mins) weekly. MSCs will be administrated for 8 doses.
Glucocorticoids
Glucocorticoids (i.e. Methylprednisolone) will be used with an initial dose of 1mg/kg.
cyclosporine
Cyclosporine (CsA) will be used with an initial dose of 2.5mg/kg/d and adjusted according to the concentration of CsA. The targeted concentration is 200-300 ng/Ml.
Eligibility Criteria
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Inclusion Criteria
* Recipients of allogeneic hematopoietic stem cell transplantation Patients with moderate/ severe cGVHD without systemic treatment
* Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Exclusion Criteria
* Primary disease relapse
* Expected lifetime less than 3 months
* Patients with any conditions not suitable for the trial (investigators' decision)
18 Years
65 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Army Medical University, China
OTHER
Peking University People's Hospital
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Qifa Liu
Professor
Principal Investigators
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Qi-fa Liu, MD
Role: PRINCIPAL_INVESTIGATOR
Nanfang Hospital, Southern Medical University
Locations
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Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Ren Lin, MD
Role: primary
Other Identifiers
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MSC-cGVHD-2020
Identifier Type: -
Identifier Source: org_study_id