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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: |
NCT01420432 |
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Date of registration:
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11/08/2011 |
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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 Ankylosing Spondylitis (AS)
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Scientific title:
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Phase II Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat AS |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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10 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01420432 |
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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 1
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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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+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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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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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patient age 18~60 years old with plan to infuse MSCs.
2. Diagnosis of "Definite AS" (arthritis of the spine) as defined by the modified New
York criteria
3. Stable doses of sulfasalazine,methotrexate,thalidomide,hydroxychloroquine, low-dose
corticosteroids, and NSAIDs are permitted
4. Patients must have an ECOG 0~2.
5. No moderate or sever organ dysfunction: Ejection fraction>45%; Creatinine <176
umol/L.
6. No severe infection.
7. Each patient must sign written informed consent.
Exclusion Criteria:
1. Other serious concomitant diseases (uncontrolled/severe kidney, liver,
haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological
or cerebral disease)
2. Psychiatric condition that would limit informed consent.
3. HIV, hepatitis B or C, tuberculosis, other infections
4. Positive Pregnancy Test or lactation
5. Patient has enrolled another clinical trial study within last 4 weeks.
6. Contraindications to MSC
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ankylosing Spondylitis
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Intervention(s)
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Biological: Human umbilical cord-derived MSCs
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Primary Outcome(s)
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erythrocyte sedimentation rate (ESR)
[Time Frame: 1 year]
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imageology
[Time Frame: 1 year]
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C-reactive protein (CRP)
[Time Frame: 1 year]
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The Assessment of Spondyloarthritis International Society (ASAS)20 response
[Time Frame: 1 year]
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Secondary Outcome(s)
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Percentage of systemic T regulatory cell population
[Time Frame: 1 year]
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Side effects
[Time Frame: 1 year]
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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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