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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02241018 |
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Date of registration:
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13/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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MSCs Combined With CD25 Monoclonal Antibody and Calcineurin Inhibitors for Treatment of Steroid-resistant aGVHD
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Scientific title:
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Mesenchymal Stem Cells Combined With CD25 Monoclonal Antibody and Calcineurin Inhibitors for Treatment of Steroid-resistant Acute Graft-versus-host Disease After Allogeneic Stem Cell Transplantation |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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200 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02241018 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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China
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Contacts
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Name:
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Ren Lin, MD |
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Address:
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Telephone:
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+86-020-62787883 |
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Email:
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lansinglinren@hotmail.com |
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Affiliation:
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Name:
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Ren Lin |
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Address:
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Telephone:
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+86-020-62787883 |
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Email:
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lansinglinren@hotmail.com |
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Affiliation:
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Name:
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Qifa Liu, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Nanfang Hospital of Southern Medical University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- age of 14-65 years
- steroid-resistant aGVHD
- subjects (or their legally acceptable representatives) must have signed an informed
consent document
Exclusion Criteria:
- Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood
pressure)
- Patients with any conditions not suitable for the trial (investigators' decision)
Age minimum:
14 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Graft-versus-host Disease
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Intervention(s)
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Drug: CD25 monoclonal antibody
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Drug: calcineurin inhibitors
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Biological: MSCs
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Primary Outcome(s)
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The efficacy of treatment for steroid-resistant aGVHD
[Time Frame: 1 year]
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Secondary Outcome(s)
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Incidence of chronic GVHD
[Time Frame: 1 year]
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Incidence of primary underlying disease relapse
[Time Frame: 1 year]
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Incidence of infections
[Time Frame: 1 year]
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Secondary ID(s)
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NFH-MSC-aGVHD-2014
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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