Treatment with Ex Vivo Expanded Autologous Regulatory CD4 + CD25 + Foxp3 + CD127 low T Cells Restores the Balance of the Immune System in Patients with Remitting Multiple Sclerosis

Objective. To assess the clinical efficacy and safety of autologous (patient's own) T_reg cells – CD4⁺CD25⁺Foxp3⁺CD127^low – isolated from the blood of patients with remitting multiple sclerosis (RMS). Patients with autoimmune diseases have decreased numbers and impaired suppressor functions of peripheral T_reg cells circulating in the blood. With the aim of correcting the defect in peripheral T_reg, precursor cells were isolated and expanded outside the patient's body (ex vivo), and an increased number of autologous (patient's own) T_reg cells were given in the form of T_reg vaccine. Materials and methods. An ex vivo cultivation method was developed which increased the number of T_reg cells by factors of 30–40 over 5–7 days. Ex vivo expanded cells contained more than 90% CD4⁺CD25⁺Foxp3⁺CD127^low T_reg cells and had high levels of suppressor activity. A total of 14 patients with MS took part in a pilot trial and received s.c. ex vivo expanded T_reg cells at doses of (2.8–4.5)·10⁸ cells per injection. Observations were continued for one year. Results and discussion. Blood T_reg levels in patients increased by factors of 1.5–2. No adverse reactions were seen during the study period; exacerbation frequency decreased, and the index of disability stabilized. It is suggested that ex vivo expanded T_reg may compensate for impairments to the functions of peripheral T_reg and can be used for the adoptive immunotherapy of RMS.

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