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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: |
NCT01182662 |
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Date of registration:
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11/08/2010 |
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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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Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Severe Aplastic Anemia
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Scientific title:
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Phase II Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat SAA |
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Date of first enrolment:
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August 2010 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01182662 |
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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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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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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chengyun zheng, Ph. D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Hematology of The 2nd Hospital of Shandong University |
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Name:
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chengyun zheng, Ph. D |
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Address:
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Telephone:
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+86-531-85875635 |
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Email:
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chengyun.zheng@ki.se |
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Affiliation:
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Name:
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chengyun zheng, Ph. D |
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Address:
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Telephone:
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+86-531-85875635 |
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Email:
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chengyun.zheng@ki.se |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patient age 18~80 years old with plan to infuse MSCs.
2. Standard of diagnosis of aplastic anemia is according to Chinese domestic
classification of AA for 1987.
3. Patients must have an ECOG 0~2.
4. No moderate or sever organ dysfunction: Ejection fraction>45%; Creatinine <176
umol/L.
5. No active severe viral or fungus infection.
6. Each patient must sign written informed consent.
Exclusion Criteria:
1. Psychiatric condition that would limit informed consent.
2. HIV positive
3. Positive Pregnancy Test
4. Patient has enrolled another clinical trial study within last 4 weeks.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Aplastic Anemia
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Intervention(s)
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Other: cyclosporin A
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Other: Human umbilical cord-derived MSCs and cyclosporin A
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Primary Outcome(s)
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SAA clinical symptoms
[Time Frame: 1 year]
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Bone borrow hemocytology
[Time Frame: 1 year]
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The number of blood cells
[Time Frame: 1 year]
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Secondary Outcome(s)
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Percentage of systemic T regulatory cell population and T lymphocyte subsets
[Time Frame: 1 year]
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Secondary ID(s)
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No. 30670903
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kongdx
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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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