Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis
NCT ID: NCT02643823
Last Updated: 2016-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
40 participants
INTERVENTIONAL
2016-01-31
2017-06-30
Brief Summary
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Detailed Description
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To investigate the effects of hUC-MSC treatment for Rheumatoid Arthritis, 20 patients with Rheumatoid Arthritis will be enrolled and receive 4 times of hUC-MSC transplantation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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hUC-MSC + DMARDs
Patients will be treated in combination with hUC-MSC and DMARDs with a 12 months follow-up.
hUC-MSC + DMARDs
Patients will be treated by conventional drugs (DMARDs) for alleviating disease. Combinated with a single dose of 2×107 hUC-MSC will treated to patients, IV, Repeat every weeks for four times.
DMARDs
Patients will be treated by Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs) with a 12 months follow-up.
DMARDs
Patients will be treated by conventional drugs (DMARDs) for alleviating disease.
Interventions
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hUC-MSC + DMARDs
Patients will be treated by conventional drugs (DMARDs) for alleviating disease. Combinated with a single dose of 2×107 hUC-MSC will treated to patients, IV, Repeat every weeks for four times.
DMARDs
Patients will be treated by conventional drugs (DMARDs) for alleviating disease.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Futian People's Hospital
OTHER
Shenzhen Hornetcorn Bio-technology Company, LTD
INDUSTRY
Responsible Party
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Principal Investigators
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Zhong Z Ye, Professor
Role: PRINCIPAL_INVESTIGATOR
Futian People's Hospital
Locations
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The Fourth People's Hospital of Shenzhen
Shenzhen, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HYK-Rheumatoid Arthritis
Identifier Type: -
Identifier Source: org_study_id
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