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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: |
NCT02240992 |
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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 With or Without Peripheral Blood Stem Cell for Treatment of Poor Graft Function and Delayed Platelet Engraftment
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Scientific title:
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Mesenchymal Stem Cells With or Without G-CSF Mobilized Peripheral Blood Stem Cell for Treatment of Poor Graft Function and Delayed Platelet Engraftment After Allogeneic Hematopoietic Stem Cell Transplant |
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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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120 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02240992 |
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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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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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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, 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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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age:14-65 years
- PGF or DPE after allo-HSCT
- 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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Poor Graft Function
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Hematological Diseases
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Delayed Platelet Engraftment
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Stem Cell Transplantation, Hematopoietic
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Intervention(s)
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Biological: MSCs
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Biological: PBSC
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Primary Outcome(s)
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Percentage of Participants with Hematopoietic Recovery
[Time Frame: 1 year]
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Secondary Outcome(s)
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Incidence of acute toxicity
[Time Frame: up to 100 days]
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Incidence of infections
[Time Frame: 1 year]
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Incidence of graft-versus-host disease
[Time Frame: 1 year]
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Incidence of primary underlying disease relapse
[Time Frame: 1 year]
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Secondary ID(s)
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NFH-PBSC-MSC-PGF-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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