Safety and Efficacy Study of Umbilical Cord-Derived Mesenchymal Stem Cells for Rheumatoid Arthritis (RA)
|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 (Clinical Trial)|
|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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01547091
|Contact: Mingyuan Wu, MD,PhDemail@example.com|
|Contact: Haijie Ji, MDfirstname.lastname@example.org|
|The 323 Hospital of Chinese People's Liberation Army||Recruiting|
|Xi'an, Shaanxi, China, 710054|
|Contact: Liming Wang, MD 86-29-84756502 email@example.com|
|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.|