Safety and Efficacy Study of Umbilical Cord-Derived Mesenchymal Stem Cells for Rheumatoid Arthritis (RA)
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|ClinicalTrials.gov Identifier: NCT01547091|
Recruitment Status : Unknown
Verified March 2013 by Alliancells Bioscience Corporation Limited.
Recruitment status was: Recruiting
First Posted : March 7, 2012
Last Update Posted : June 27, 2013
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Biological: Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs) Drug: Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs) Biological: UC-MSC+DMARDS||Phase 1 Phase 2|
|Study Type :||Interventional|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Trial of Umbilical Cord-Derived Mesenchymal Stem Cells Transplantation for Rheumatoid Arthritis-Phase I/II|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||October 2014|
|Estimated Study Completion Date :||December 2014|
Experimental: UC-MSCs Treatment
Patients in UC-MSCs treatment will be infused umbilical cord-derived mesenchymal stem cells intravenously only.
Biological: Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs)
-The UC-MSCs will be infused intravenously(single dose, 4x10^7 cells).The interval time is 3 months, and the study lasts for 12 months with 4 times infusion.
Active Comparator: DMARDS
Patients will be treated by Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs).
Drug: Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs)
-Patients will be treated by conventional drugs (DMARDS) for alleviating disease.
Active Comparator: UC-MSC+DMARDS
Patients will be treated in combination with UC-MSC and DMARDS.
The UC-MSCs will be infused intravenously(single dose, 4x10^7 cells).The interval time is 3 months, and the study lasts for 12 months with 4 times infusion.Meanwhile,patients will be treated by conventionally drugs if the disease is still not alleviated.
- Safety of MSC treatment. [ Time Frame: six months ]Adverse Events will be recorded in a patient or clinical investigation subject who administers MSC and will be evaluated a causal relationship with the treatment.
- RA Serology [ Time Frame: 1, 3 and 6 months ]Rheumatoid Factor, C-reactive protein
- Disease Activity Score (DAS 28) Index Mean Change From Baseline [ Time Frame: 1, 3 and 6 months ]
- Patient's assessment of pain. [ Time Frame: 1, 3 and 6 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): NCT01547091
|Contact: Mingyuan Wu, MD,PhDfirstname.lastname@example.org|
|Contact: Haijie Ji, MDemail@example.com|
|The 323 Hospital of Chinese People's Liberation Army||Recruiting|
|Xi'an, Shaanxi, China, 710054|
|Contact: Liming Wang, MD 86-29-84756502 firstname.lastname@example.org|
|Principal Investigator: Liming Wang, MD|
|Principal Investigator:||Mingyuan Wu, MD,PhD||Eastern Union Stem Cell & Gene Engineering Co.,Ltd，Alliancells Biosciences Co., Ltd|
|Principal Investigator:||Yongjun Liu, MD,PhD||Alliancells Biosciences Co., Ltd|
|Study Director:||Liming Wang, MD||The 323 Hospital of Chinese People's Liberation Army|
|Principal Investigator:||Haijie Ji, MD||Alliancells Biosciences Co., Ltd.|