Mesenchymal progenitor cells in the therapy of rheumatoid arthritis
On January 30 of this year, the Australian company Mesoblast Limited, specializing in the development of regenerative medicine methods, received permission from the US Food and Drug Administration to launch a phase II clinical trial to evaluate the effectiveness of a single intravenous injection of allogeneic mesenchymal progenitor cells for the treatment of rheumatoid arthritis.
A randomized, double-blind, placebo-controlled trial is scheduled to begin in the second quarter of 2013. Several medical centers in Australia and the USA will take part in it. The study will compare the effects of a single intravenous injection of allogeneic mesenchymal progenitor cells at doses of 1 or 2 million cells per kilogram of the patient's body weight and placebo. The study will include 48 patients with weak or inadequate response to a biological inhibitor of the signaling mechanism mediated by tumor necrosis factor-alpha, used in the treatment of active rheumatoid arthritis. Evaluation of the safety and effectiveness of therapy with mesenchymal progenitor cells will be evaluated repeatedly within 3 months after therapy.
Rheumatoid arthritis is an autoimmune disease, the cause of which is the abnormal activation of many immune mechanisms, including monocytes and leukocytes, which ultimately leads to the destruction of joints. Existing biological treatments affect only certain immune mechanisms and provide only a partial response. Moreover, they imply the constant use of drugs and are fraught with potentially life-threatening infectious complications.
The Mesoblast Limited drug developed by mesenchymal progenitor cells, on the contrary, during preclinical studies demonstrated a wide range of immunomodulatory activity that provides simultaneous inhibition of T cells and monocytes involved in the development of inflammatory and autoimmune processes.
When conducting a randomized placebo-controlled study on 30 sheep with collagen-induced arthritis, used as a model of human joint injuries characteristic of rheumatoid arthritis, therapy with mesenchymal progenitor cells led to a significant (31%) decrease in the severity of pathological changes in the tissue of the affected joint. Compared with control group animals receiving saline injections, 30 days after the introduction of mesenchymal progenitor cells at a dose of 2 million per kilogram of body weight, sheep synovial tissue contained 43% fewer infiltrating monocytes/macrophages, as well as significantly fewer pro-inflammatory factors produced by them, such as interleukin-6, tumor necrosis factor-alpha and interlekin-17 – by 88%, 83% and 53%, respectively.
The executive director of Mesoblast Limited, Professor Silviu Itescu, stated that the company's specialists are confident that the wide range of immunomodulatory effects of the mesenchymal progenitor cell drug they have developed can provide significant relief to patients with autoimmune diseases leading to disability, including rheumatoid arthritis. The ongoing program is the first of a series of programs aimed at obtaining permits for the use of the presented drug for intravenous administration in the treatment of a wide range of inflammatory and immunological diseases.
Evgeniya Ryabtseva
Portal "Eternal youth" http://vechnayamolodost.ru Based on Mesoblast Limited: Mesoblast receives FDA clearance for phase 2 clinical trial of mesenchymal precursor cells in patients with active rheumatoid arthritis.
04.02.2013