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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
Sponsor:
Information provided by (Responsible Party):
Alliancells Bioscience Corporation Limited

February 22, 2012
March 7, 2012
June 27, 2013
April 2013
October 2014   (Final data collection date for primary outcome measure)
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.
Safety and tolerability 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 evaulated a causal relationship with the treatment.
Complete list of historical versions of study NCT01547091 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of Umbilical Cord-Derived Mesenchymal Stem Cells for Rheumatoid Arthritis
Clinical Trial of Umbilical Cord-Derived Mesenchymal Stem Cells Transplantation for Rheumatoid Arthritis-Phase I/II
Rheumatoid arthritis is a chronic systemic disease, which is characterized by chronic inflammation in the synovial tissue. Rheumatoid arthritis will eventually result in the destruction of cartilage, bone and ligaments and joint deformity. The underlying hypothesis is that umbilical cord-derived mesenchymal stem cell (UC-MSCs) has anti-inflammatory effects and thus potentially alleviates the progression of rheumatoid arthritis. The study is to explore the safety and efficacy of UC-MSCs transplantation in treatment of rheumatoid arthritis.
This study was supported by the National Natural Science Foundation of China (30872618),The Shanxi Province Social Development Public Relations Project (2012K13-02-35), and The Military Medicine and Public Health Plan (CLZ120GA23)
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • 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.
  • Drug: Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs)
    -Patients will be treated by conventional drugs (DMARDS) for alleviating disease.
  • Biological: UC-MSC+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.
  • Experimental: UC-MSCs Treatment
    Patients in UC-MSCs treatment will be infused umbilical cord-derived mesenchymal stem cells intravenously only.
    Intervention: Biological: Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs)
  • Active Comparator: DMARDS
    Patients will be treated by Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs).
    Intervention: Drug: Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs)
  • Active Comparator: UC-MSC+DMARDS
    Patients will be treated in combination with UC-MSC and DMARDS.
    Intervention: Biological: UC-MSC+DMARDS

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
200
150
December 2014
October 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients fulfilled the classification criteria (2010) for rheumatoid arthritis, man or woman aged from 18 to 70 years old.
  • Patients must be informed of the investigational nature of this study and give written informed consent in accordance with the institutional and hospital guidelines.
  • Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on this trial. Women of child-bearing potential must have a pregnancy test performed within 72 hours prior to initiation of treatment.

Exclusion Criteria:

  • Any history of ongoing, significant or recurring infections.
  • Any active inflammatory diseases other than RA.
  • Significant cardiac or pulmonary disease.
  • End-stage renal failure.
  • Pregnant or nursing women may not participate due to the possibility of fetal harm or harm to nursing infants from this treatment regimen.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01547091
Alliancells-1
No
Not Provided
Not Provided
Alliancells Bioscience Corporation Limited
Alliancells Bioscience Corporation Limited
Not Provided
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.
Alliancells Bioscience Corporation Limited
March 2013