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Study aim
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Evaluation of the safety of repeated intravenous injection of foreign bone marrow-derived clonal mesenchymal stem cells in patients with rheumatoid arthritis
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Design
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Patients will enter the study in a regular order. The first patient is monitored for 3 months and if cell therapy is safe, the next patient will enter the study 3 months later and will be monitored for 2 months. Again, provided it was safe, the treatment performed during this period, the third patient will enter the study. This time it will be followed up for a month and in the absence of severe and life-threatening complications, the next patients will be included in the study.
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Settings and conduct
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Location: Shariati Hospital and Imam Khomeini Hospital and Rheumatism Center of Iran
Clinical and paraclinical studies before stem cell injection include initial clinical examinations, necessary laboratory tests, and related questionnaires.
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Participants/Inclusion and exclusion criteria
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People aged 18 to 60 years with refractory rheumatoid arthritis who willingly participate in the study are included.
People with other chronic diseases, allergies or any unstable clinical conditions as well as pregnancy and lactation and people who plan to become pregnant during the study or for any reason do not use safe contraceptive methods are not included in the study.
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Intervention groups
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Injection material: Clonal mesenchymal stem cells derived from allogeneic bone marrow tissue
Injection rate: 1 million cells per kilogram of body weight (70 million allogeneic bone marrow-derived mesenchymal stem cells) in sac form
• Injection method: Intravenous/ 3 times
Interval between each injection: 1 month
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Main outcome variables
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No side effects, including short-term and long-term, systemic or local, and severe or mild, related and unrelated to cell therapy (1 week and 1, 2, 3, 4 and 6 months after the first injection) By reviewing CTCAE v4