Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis
Safety and Efficacy Study of Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for Rheumatoid Arthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 rheumatoid-arthritis
Started Jan 2016
Typical duration for phase_1 rheumatoid-arthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2015
CompletedFirst Posted
Study publicly available on registry
December 31, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedMay 24, 2016
December 1, 2015
1 year
December 23, 2015
May 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Severity of adverse events
According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)
12 months
Secondary Outcomes (2)
RA Serology
1, 3 ,6 and 12 months
Disease Activity Score (DAS 28) Index
1, 3, 6 and 12 months
Study Arms (2)
hUC-MSC + DMARDs
EXPERIMENTALPatients will be treated in combination with hUC-MSC and DMARDs with a 12 months follow-up.
DMARDs
ACTIVE COMPARATORPatients will be treated by Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs) with a 12 months follow-up.
Interventions
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.
Patients will be treated by conventional drugs (DMARDs) for alleviating disease.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Fourth People's Hospital of Shenzhen
Shenzhen, Guangdong, 518000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhong Z Ye, Professor
Futian People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2015
First Posted
December 31, 2015
Study Start
January 1, 2016
Primary Completion
January 1, 2017
Study Completion
June 1, 2017
Last Updated
May 24, 2016
Record last verified: 2015-12