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Trial record 69 of 799 for:    Interventional Studies | mesenchymal

Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis

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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

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: hUC-MSC + DMARDs Drug: DMARDs Phase 1

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 : Interventional
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Study of Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis
Study Start Date : January 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: hUC-MSC + DMARDs
Patients will be treated in combination with hUC-MSC and DMARDs with a 12 months follow-up.
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

Active Comparator: DMARDs
Patients will be treated by Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs) with a 12 months follow-up.
Drug: DMARDs
Patients will be treated by conventional drugs (DMARDs) for alleviating disease.
Other Names:
  • NSAIDs
  • Methotrexate




Primary Outcome Measures :
  1. Severity of adverse events [ Time Frame: 12 months ]
    According to National Cancer Institute Common Terminology Criteria for Adverse Events(NCI-CTCAE)


Secondary Outcome Measures :
  1. RA Serology [ Time Frame: 1, 3 ,6 and 12 months ]
    Rheumatoid Factor, C-reactive protein

  2. Disease Activity Score (DAS 28) Index [ Time Frame: 1, 3, 6 and 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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): NCT02643823


Contacts
Contact: Wei J Zhong +86 0755-83980805 ZhongJW@163.com

Locations
China, Guangdong
The Fourth People's Hospital of Shenzhen Recruiting
Shenzhen, Guangdong, China, 518000
Contact: Hao J, Professor    0755-83981333    HaoJ@hotmail.com   
Sponsors and Collaborators
Shenzhen Hornetcorn Bio-technology Company, LTD
Futian People's Hospital
Investigators
Principal Investigator: Zhong Z Ye, Professor Futian People's Hospital

Responsible Party: Shenzhen Hornetcorn Bio-technology Company, LTD
ClinicalTrials.gov Identifier: NCT02643823     History of Changes
Other Study ID Numbers: HYK-Rheumatoid Arthritis
First Posted: December 31, 2015    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Shenzhen Hornetcorn Bio-technology Company, LTD:
Human Umbilical Cord Mesenchymal Stem Cell
Mesenchymal Stem Cell
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents