The Safety and Effects of Mesenchymal Stem Cell (MSCs) in the Treatment of Rheumatoid Arthritis
NCT ID: NCT03798028
Last Updated: 2019-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
250 participants
INTERVENTIONAL
2017-12-26
2020-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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UC-MSCs treatment
the participants will receive the single-dose UC-MSCs (1×10\^6 cells/kg ) in combined with the present treatment.
UC-MSCs
The UC-MSCs will be administrated by intravenous injection at the dose of 1×10\^6 cells/kg.
no UC-MSCs treatment
the participants will receive the placebo in combined with the present treatment.
No interventions assigned to this group
Interventions
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UC-MSCs
The UC-MSCs will be administrated by intravenous injection at the dose of 1×10\^6 cells/kg.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
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.
18 Years
70 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
Southwest Hospital, China
OTHER
Xijing Hospital
OTHER
Responsible Party
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Locations
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Xijing Hospital
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2014ZX09508002
Identifier Type: -
Identifier Source: org_study_id
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