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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03798028
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Xijing Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Rheumatoid Arthritis

Arms & Interventions

Arms

Experimental: UC-MSCs treatment

the participants will receive the single-dose UC-MSCs (1×10^6 cells/kg ) in combined with the present treatment.

No Intervention: no UC-MSCs treatment

the participants will receive the placebo in combined with the present treatment.

Interventions

Biological: - UC-MSCs

The UC-MSCs will be administrated by intravenous injection at the dose of 1×10^6 cells/kg.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.