Status:
UNKNOWN
The Safety and Effects of Mesenchymal Stem Cell (MSCs) in the Treatment of Rheumatoid Arthritis
Lead Sponsor:
Xijing Hospital
Collaborating Sponsors:
Changhai Hospital
Southwest Hospital, China
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-70 years
Phase:
NA
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 accom...
Eligibility Criteria
Inclusion
- Fulfill 2010 ACR/ the European League Against Rheumatism (EULAR) classification criteria or the 1987 ACR classification criteria.
- Age limits:18 to 70 years old.
- Freely given informed consent.
- Disease Activity Score (DAS) 28≥3.2或 Simple Disease Activity Index (SDAI)\>11.0或 Clinical Disease Activity Index (CDAI) \>10.0.
- Hemoglobin \< 90 g/L and/or interstitial lung disease shown in high resolution CT.
- 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.
- 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
- Participants who received glucocorticoid therapy by intra-articular injection within 1 week.
- Glucocorticoid that participants received is more than 10 mg/day of prednisone within 1 months.
- Complication with other connective tissue disease (except for Sjogren syndrome) .
- Participants with chronic and acute infection (bacteria, virus and parasite,etc.).
- Participants with acute and chronic tuberculosis infection.
- Malignant tumors or participants with a family history of malignant tumors.
- Participants have a family history of allergic conditions.
- Participants infected by Hepatitis B Virus(HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus （HIV）.
- Participants suffer from central nervous system demyelinating disease or multiple sclerosis (MS) currently or in the past.
- Participants received live vaccines with 3 months.
- Drug abuse and alcoholism.
- Participants with severe mental or neurological disorders that affect informed consent and/or the presentation or observer of adverse events.
- Participants with pregnant or in breast-feeding, and patients who has a pregnancy plan within 1 year.
- Participants received stem cell therapy in the past.
- Participants received any biological agents within 3 months.
- Anemia (such as anemia with dysplasia) and interstitial lung disease for other reasons.
- Participants with cardiovascular and cerebrovascular damage, such as thrombosis.
- Participants taking drugs that affect the test for blood and lung.
- Participants taking any traditional Chinese medicine.
- Participants taking immune modulators such as Transfer Factor, Thymosin and Intravenous Immunoglobulin (IVIG), and so on.
- Other cases that participants are considered by investigator that they did not meet the requirements for enrollment.
Key Trial Info
Start Date :
December 26 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2020
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT03798028
Start Date
December 26 2017
End Date
June 30 2020
Last Update
January 9 2019
Active Locations (1)
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1
Xijing Hospital
Xi'an, Shaanxi, China, 710032