Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02643823|
Recruitment Status : Unknown
Verified December 2015 by Shenzhen Hornetcorn Bio-technology Company, LTD.
Recruitment status was: Recruiting
First Posted : December 31, 2015
Last Update Posted : May 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Biological: hUC-MSC + DMARDs Drug: DMARDs||Phase 1|
Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into chondrocyte and osteocyte, which have been confirmed in in vivo and in vitro experiments. There have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of Rheumatoid Arthritis.
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.
|Study Type :||Interventional|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy Study of Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||June 2017|
Experimental: hUC-MSC + DMARDs
Patients will be treated in combination with hUC-MSC and DMARDs with a 12 months follow-up.
Biological: 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.
Other Name: Human Umbilical Cord-Mesenchymal Stem Cells
Active Comparator: DMARDs
Patients will be treated by Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs) with a 12 months follow-up.
Patients will be treated by conventional drugs (DMARDs) for alleviating disease.
- Severity of adverse events [ Time Frame: 12 months ]According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)
- RA Serology [ Time Frame: 1, 3 ,6 and 12 months ]Rheumatoid Factor, C-reactive protein
- Disease Activity Score (DAS 28) Index [ Time Frame: 1, 3, 6 and 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02643823
|Contact: Wei J Zhong||+86 0755-83980805||ZhongJW@163.com|
|The Fourth People's Hospital of Shenzhen||Recruiting|
|Shenzhen, Guangdong, China, 518000|
|Contact: Hao J, Professor 0755-83981333 HaoJ@hotmail.com|
|Principal Investigator:||Zhong Z Ye, Professor||Futian People's Hospital|