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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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13 June 2016 |
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Main ID: |
NCT02643823 |
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Date of registration:
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23/12/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis
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Scientific title:
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Safety and Efficacy Study of Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis |
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Date of first enrolment:
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January 2016 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02643823 |
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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: Open Label, 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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Zhong Z Ye, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Futian People's Hospital |
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Name:
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Hao J, Professor |
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Address:
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Telephone:
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0755-83981333 |
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Email:
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HaoJ@hotmail.com |
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Affiliation:
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Name:
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Wei J Zhong |
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Address:
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Telephone:
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+86 0755-83980805 |
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Email:
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ZhongJW@163.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Aged 18-80 Rheumatoid Arthritis patient;
- Patients must consent in writing to participate in the study by signing and dating an
informed consent document;
- Patients must have a diagnosis of Rheumatoid Arthritis according to the 2010
ACR/EULAR criteria for at least 12 weeks duration;
- Stage I and II according to X-ray.
Exclusion Criteria:
- History of neurological disease, head injury or psychiatric disorder;
- Pregnant women;
- Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor
or special condition;
- Progressive apoplexy;
- With malignant tumors;
- Patients who had participated in other clinical trials within three months prior to
this study.
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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Rheumatoid Arthritis
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Intervention(s)
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Drug: DMARDs
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Biological: hUC-MSC + DMARDs
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Primary Outcome(s)
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Severity of adverse events
[Time Frame: 12 months]
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Secondary Outcome(s)
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RA Serology
[Time Frame: 1, 3 ,6 and 12 months]
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Disease Activity Score (DAS 28) Index
[Time Frame: 1, 3, 6 and 12 months]
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Secondary ID(s)
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HYK-Rheumatoid Arthritis
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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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