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Trial record 12 of 156 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

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: UC-MSCs Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effects and Safety of Mesenchymal Stem Cells in the Treatment of Moderate/Severe Rheumatoid Arthritis, a Multicenter Randomized Controlled Clinical Study
Actual Study Start Date : December 26, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: UC-MSCs treatment
the participants will receive the single-dose UC-MSCs (1×10^6 cells/kg ) in combined with the present treatment.
Biological: UC-MSCs
The UC-MSCs will be administrated by intravenous injection at the dose of 1×10^6 cells/kg.
Other Name: placebo

No Intervention: no UC-MSCs treatment
the participants will receive the placebo in combined with the present treatment.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. Image improvement of lung on high resolution CT. [ Time Frame: 24 weeks ]
    The area change of image of lung.

  6. Improvement of 6-minute walking distance compared to baseline. [ Time Frame: 12 weeks and 24 weeks ]


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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:

  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.

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): NCT03798028


Contacts
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Contact: Ping Zhu, Doctor 86-29-84773951 zhuping@fmmu.edu.cn

Locations
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China, Shaanxi
Xijing Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Ping Zhu    862984773951 ext 862984773951    zhuping@fmmu.edu.cn   
Sponsors and Collaborators
Xijing Hospital
Changhai Hospital
Southwest Hospital, China

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Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT03798028     History of Changes
Other Study ID Numbers: 2014ZX09508002
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xijing Hospital:
anemia
Interstitial pulmonary disease

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