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Trial record 12 of 159 for:    stem cell arthritis AND Arthritis

The Safety and Effects of Mesenchymal Stem Cell (MSCs) in the Treatment of Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT03798028
Recruitment Status : Recruiting
First Posted : January 9, 2019
Last Update Posted : January 9, 2019
Sponsor:
Collaborators:
Changhai Hospital
Southwest Hospital, China
Information provided by (Responsible Party):
Xijing Hospital

Tracking Information
First Submitted Date  ICMJE January 7, 2019
First Posted Date  ICMJE January 9, 2019
Last Update Posted Date January 9, 2019
Actual Study Start Date  ICMJE December 26, 2017
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2019)
  • Improvement rate of blood routine hemoglobin (HGB) compared to baseline. [ Time Frame: 24 weeks ]
    The HGB increases by 10g compared to the baseline is considered improvement.
  • Improvement rate of forced vital capacity (FVC) and/or carbon monoxide diffusing capacity (DLCO) compared to baseline. [ Time Frame: 24 weeks ]
    FVC increases by 0.5% and DLCO increases by 10% compared to baseline are considered improvement.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2019)
  • The remission rates of American College of Rheumatology (ACR) 20, ACR 50 and ACR 70. [ Time Frame: 12 weeks and 24 weeks ]
    The patients achieves 20%, 50%, or 70% remission according to American College of Rheumatology (ACR) criteria.
  • White blood cell count and platelet count improved compared to the baseline. [ Time Frame: 12 weeks and 24 weeks ]
    White blood cell count increases to the 3.5×10^9/L and platelet count increases to 80×10^ 9.
  • Improvement rate of blood routine hemoglobin (HGB) compared to baseline. [ Time Frame: 12 weeks ]
    The HGB increases by 10 g compared to the baseline is considered improvement.
  • Improvement rate of forced vital capacity (FVC) and/or carbon monoxide [ Time Frame: 12 weeks ]
    FVC increases by 0.5% and DLCO increases by 10% compared to baseline
  • Image improvement of lung on high resolution CT. [ Time Frame: 24 weeks ]
    The area change of image of lung.
  • Improvement of 6-minute walking distance compared to baseline. [ Time Frame: 12 weeks and 24 weeks ]
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 The Safety and Effects of Mesenchymal Stem Cell (MSCs) in the Treatment of Rheumatoid Arthritis
Official Title  ICMJE The Effects and Safety of Mesenchymal Stem Cells in the Treatment of Moderate/Severe Rheumatoid Arthritis, a Multicenter Randomized Controlled Clinical Study
Brief Summary This study evaluates the safety and therapeutic effects of single-dose human umbilical cord blood mesenchymal stem cells (UC-MSCs) on the adult patients with moderate/severe Rheumatoid Arthritis accompany with anemia or/and Interstitial pulmonary disease. Half of participants will receive UC-MSCs and keep the present medication,while the other half will receive a placebo and keep the present medication.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE Biological: UC-MSCs
The UC-MSCs will be administrated by intravenous injection at the dose of 1×10^6 cells/kg.
Other Name: placebo
Study Arms  ICMJE
  • Experimental: UC-MSCs treatment
    the participants will receive the single-dose UC-MSCs (1×10^6 cells/kg ) in combined with the present treatment.
    Intervention: Biological: UC-MSCs
  • No Intervention: no UC-MSCs treatment
    the participants will receive the placebo in combined with the present treatment.
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 7, 2019)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Fulfill 2010 ACR/ the European League Against Rheumatism (EULAR) classification criteria or the 1987 ACR classification criteria.
  2. Age limits:18 to 70 years old.
  3. Freely given informed consent.
  4. Disease Activity Score (DAS) 28≥3.2或 Simple Disease Activity Index (SDAI)>11.0或 Clinical Disease Activity Index (CDAI) >10.0.
  5. Hemoglobin < 90 g/L and/or interstitial lung disease shown in high resolution CT.
  6. Poor response to current treatment. The current treatment refers to receive the medicines (including Leflunomide, Methotrexate, Sulphasalazine, Hydroxychloroquine, Cyclosporine A,and Tacrolimus, alone or in combination ) for 3 months, and maintain the stable-dose of drugs for at least 1 month.
  7. More than 3 months and a stable dose for at least 1 month are required if glucocorticoid is used. The dose of glucocorticoid is less than or equal to10mg/ day of prednisone.

Exclusion Criteria:

  1. Participants who received glucocorticoid therapy by intra-articular injection within 1 week.
  2. Glucocorticoid that participants received is more than 10 mg/day of prednisone within 1 months.
  3. Complication with other connective tissue disease (except for Sjogren syndrome) .
  4. Participants with chronic and acute infection (bacteria, virus and parasite,etc.).
  5. Participants with acute and chronic tuberculosis infection.
  6. Malignant tumors or participants with a family history of malignant tumors.
  7. Participants have a family history of allergic conditions.
  8. Participants infected by Hepatitis B Virus(HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV).
  9. Participants suffer from central nervous system demyelinating disease or multiple sclerosis (MS) currently or in the past.
  10. Participants received live vaccines with 3 months.
  11. Drug abuse and alcoholism.
  12. Participants with severe mental or neurological disorders that affect informed consent and/or the presentation or observer of adverse events.
  13. Participants with pregnant or in breast-feeding, and patients who has a pregnancy plan within 1 year.
  14. Participants received stem cell therapy in the past.
  15. Participants received any biological agents within 3 months.
  16. Anemia (such as anemia with dysplasia) and interstitial lung disease for other reasons.
  17. Participants with cardiovascular and cerebrovascular damage, such as thrombosis.
  18. Participants taking drugs that affect the test for blood and lung.
  19. Participants taking any traditional Chinese medicine.
  20. Participants taking immune modulators such as Transfer Factor, Thymosin and Intravenous Immunoglobulin (IVIG), and so on.
  21. Other cases that participants are considered by investigator that they did not meet the requirements for enrollment.
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: Ping Zhu, Doctor 86-29-84773951 zhuping@fmmu.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03798028
Other Study ID Numbers  ICMJE 2014ZX09508002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xijing Hospital
Study Sponsor  ICMJE Xijing Hospital
Collaborators  ICMJE
  • Changhai Hospital
  • Southwest Hospital, China
Investigators  ICMJE Not Provided
PRS Account Xijing Hospital
Verification Date December 2018

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