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Trial record 1 of 1 for:    NCT01547091
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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

Tracking Information
First Submitted Date  ICMJE February 22, 2012
First Posted Date  ICMJE March 7, 2012
Last Update Posted Date June 27, 2013
Study Start Date  ICMJE April 2013
Estimated Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 3, 2012)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Umbilical Cord-Derived Mesenchymal Stem Cells for Rheumatoid Arthritis
Official Title  ICMJE Clinical Trial of Umbilical Cord-Derived Mesenchymal Stem Cells Transplantation for Rheumatoid Arthritis-Phase I/II
Brief Summary 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.
Detailed Description 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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 26, 2013)
200
Original Estimated Enrollment  ICMJE
 (submitted: March 3, 2012)
150
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01547091
Other Study ID Numbers  ICMJE Alliancells-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alliancells Bioscience Corporation Limited
Study Sponsor  ICMJE Alliancells Bioscience Corporation Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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.
PRS Account Alliancells Bioscience Corporation Limited
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP