Rheumatoid Arthritis. Rheumatoid arthritis of unspecified site with involvement of other organs and systems
Conditions
Interventions
Intervention group: Three intravenous injections of 1 million per kg of clonal mesenchymal stromal cells derived from allogeneice bone marrow tissue suspended in 15 ml normal saline at one-month inter
Sponsors
Royan institute
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Diagnosis of Rheumatoid Arthritis According to the American Rheumatism Association for at least 6 months prior to enrollment Having refractory RA means not responding to: a.At least 1 synthetic conventional anti Rheumatoid drug (synthetic conventional DMARD) b.At least 1 biologic drug DMARD or targeted synthetic DMARD in the last 6 weeks Willingness to participate in the study and sign the study informed consent form Patients of childbearing age (male and female) should agree to use an appropriate method of contraception.
Exclusion criteria
Exclusion criteria: Taking Biological and Targeted conventional Anti Rheumatoid drugs in the last 6 weeks Any live vaccination in 8 weeks before enrollment until the end of the study History of malignancy and treatment with anticancer drugs in the last 5 years History of bleeding or abnormal clotting Severe mental or neurological disorders that affect informed consent or the presentation or observation of side effects Chronic or active systemic infectious disease (HIV, HBS, HCV and HTLV1) Autoimmune disease other than RA Acquired or congenital immunodeficiency such as AIDS, CVID, lymphoma History of cerebrovascular diseases such as stroke, aneurysm and malformation of cerebral vessels, thrombosis and vascular stenosis Pregnancy and lactation and people who plan to become pregnant during the study or do not use safe contraception for any reason Pulmonary embolism or anti phospholipid syndrome Known allergy or history of allergies to medicinal products, eggs and blood products History of chronic obstructive pulmonary disease or known lung disease other than mild asthma treated with bronchodilators Patient with unstable clinical condition: uncontrolled diabetes, heart disease, advanced renal or hepatic impairment Any condition that, according to the lead researcher, cell therapy is inappropriate for the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the safety of repeated intravenous injection of allogeneic bone marrow-derived clonal mesenchymal stromal cells in patients with rheumatoid arthritis. Timepoint: one week, 1, 2, 3, 4, and 6 months after first injection. Method of measurement: CTCAE v4 questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| 20% improvement in ACR. Timepoint: Before injection, one week, 1, 2, 3, 4 and 6 months after first injection. Method of measurement: software.;50% improvement in ACR. Timepoint: Before injection, one week, 1, 2, 3, 4 and 6 months after first injection. Method of measurement: software.;70% improvement in ACR. Timepoint: Before injection, one week, 1, 2, 3, 4 and 6 months after first injection. Method of measurement: software.;Improving in health standards. Timepoint: Before injection, one week, 1, 2, 3, 4 and 6 months after first injection. Method of measurement: HAQ questionnaire.;Improvement of pain. Timepoint: Before injection, one week, 1, 2, 3, 4 and 6 months after first injection. Method of measurement: VAS score.;Improvement in LAB tests (, IL-10, Th 17, Treg, Anti-CCP, CRP, RF, ESR, GATA3 transcription factor, IL-17, TNF-a (ELISA test)). Timepoint: Before injection, 4 and 6 months after injection. Method of measurement: blood test. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHoda Madani
Royan Institute
Outcome results
None listed