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Trial record 4 of 106 for:    stem cell arthritis AND Mesenchymal

Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02643823
Recruitment Status : Unknown
Verified December 2015 by Shenzhen Hornetcorn Bio-technology Company, LTD.
Recruitment status was:  Recruiting
First Posted : December 31, 2015
Last Update Posted : May 24, 2016
Sponsor:
Collaborator:
Futian People's Hospital
Information provided by (Responsible Party):
Shenzhen Hornetcorn Bio-technology Company, LTD

Tracking Information
First Submitted Date  ICMJE December 23, 2015
First Posted Date  ICMJE December 31, 2015
Last Update Posted Date May 24, 2016
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 28, 2015)
Severity of adverse events [ Time Frame: 12 months ]
According to National Cancer Institute Common Terminology Criteria for Adverse Events(NCI-CTCAE)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02643823 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 28, 2015)
  • RA Serology [ Time Frame: 1, 3 ,6 and 12 months ]
    Rheumatoid Factor, C-reactive protein
  • Disease Activity Score (DAS 28) Index [ Time Frame: 1, 3, 6 and 12 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 Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis
Official Title  ICMJE Safety and Efficacy Study of Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis
Brief Summary The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for Rheumatoid Arthritis.
Detailed Description

Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into chondrocyte and osteocyte, which have been confirmed in in vivo and in vitro experiments. There have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of Rheumatoid Arthritis.

To investigate the effects of hUC-MSC treatment for Rheumatoid Arthritis, 20 patients with Rheumatoid Arthritis will be enrolled and receive 4 times of hUC-MSC transplantation.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Biological: hUC-MSC + DMARDs
    Patients will be treated by conventional drugs (DMARDs) for alleviating disease. Combinated with a single dose of 2×107 hUC-MSC will treated to patients, IV, Repeat every weeks for four times.
    Other Name: Human Umbilical Cord-Mesenchymal Stem Cells
  • Drug: DMARDs
    Patients will be treated by conventional drugs (DMARDs) for alleviating disease.
    Other Names:
    • NSAIDs
    • Methotrexate
Study Arms  ICMJE
  • Experimental: hUC-MSC + DMARDs
    Patients will be treated in combination with hUC-MSC and DMARDs with a 12 months follow-up.
    Intervention: Biological: hUC-MSC + DMARDs
  • Active Comparator: DMARDs
    Patients will be treated by Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs) with a 12 months follow-up.
    Intervention: Drug: DMARDs
Publications * Not Provided

*   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: December 28, 2015)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2017
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 18-80 Rheumatoid Arthritis patient;
  • Patients must consent in writing to participate in the study by signing and dating an informed consent document;
  • Patients must have a diagnosis of Rheumatoid Arthritis according to the 2010 ACR/EULAR criteria for at least 12 weeks duration;
  • Stage I and II according to X-ray.

Exclusion Criteria:

  • History of neurological disease, head injury or psychiatric disorder;
  • Pregnant women;
  • Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor or special condition;
  • Progressive apoplexy;
  • With malignant tumors;
  • Patients who had participated in other clinical trials within three months prior to this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 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 NCT02643823
Other Study ID Numbers  ICMJE HYK-Rheumatoid Arthritis
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Shenzhen Hornetcorn Bio-technology Company, LTD
Study Sponsor  ICMJE Shenzhen Hornetcorn Bio-technology Company, LTD
Collaborators  ICMJE Futian People's Hospital
Investigators  ICMJE
Principal Investigator: Zhong Z Ye, Professor Futian People's Hospital
PRS Account Shenzhen Hornetcorn Bio-technology Company, LTD
Verification Date December 2015

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