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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

Study Description
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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.

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

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Arms and Interventions
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Arm Intervention/treatment
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. RA Serology [ Time Frame: 1, 3 and 6 months ]
    Rheumatoid Factor, C-reactive protein

  2. Disease Activity Score (DAS 28) Index Mean Change From Baseline [ Time Frame: 1, 3 and 6 months ]
  3. Patient's assessment of pain. [ Time Frame: 1, 3 and 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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


Contacts
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Contact: Mingyuan Wu, MD,PhD 86-10-63188123 mingyuan-wu@ouhsc.edu
Contact: Haijie Ji, MD 86-10-63188853 jihaijie82@sohu.com

Locations
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China, Shaanxi
The 323 Hospital of Chinese People's Liberation Army Recruiting
Xi'an, Shaanxi, China, 710054
Contact: Liming Wang, MD    86-29-84756502    wanglm@fmmu.edu.cn   
Principal Investigator: Liming Wang, MD         
Sponsors and Collaborators
Alliancells Bioscience Corporation Limited
Investigators
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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.
More Information
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Publications:

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Responsible Party: Alliancells Bioscience Corporation Limited
ClinicalTrials.gov Identifier: NCT01547091    
Other Study ID Numbers: Alliancells-1
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: June 27, 2013
Last Verified: March 2013
Keywords provided by Alliancells Bioscience Corporation Limited:
Mesenchymal Stem Cells
Rheumatoid Arthritis
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
 Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents