Rheumatoid arthritis is the most common inflammatory arthritis, affecting 0.5% to 1% of the general population worldwide.
The current pharmacological management of rheumatoid arthritis relies on intervention with synthetic or biological disease modifying antirheumatic drugs.
However, rheumatoid arthritis remains as an unmet clinical need since a substantial number of patients do not have an adequate response to the current treatments, which are moreover also associated with a series of safety concerns.
Human adult mesenchymal stem cells ( MSCs ) are considered a promising tool for cell therapy in regenerative medicine as well as for treating inflammatory and autoimmune diseases. This is based on the stem cells capacities to differentiate into more specialized cells, to release trophic factors with anti-fibrotic, anti-apoptotic or pro-angiogenic properties, and on their capacity to modulate the immune response.
MSCs have been shown to exert immunomodulating properties and to regulate the function of a broad number of immune cells including B lymphocytes, T lymphocytes, macrophages and NK cells. As such, MSCs can control excessive inflammation and support the body to regain homeastasis.
Such therapeutic benefit has already been reported in a number of experimental models of inflammatory diseases such as allograft rejection, graftversus-host disease, experimental autoimmune encephalomyelitis, collagen-induced arthritis, colitis, or sepsis.
MSC therefore present a new potential therapeutic approach for treating rheumatoid arthritis in humans.
Researchers at Tigenix ( The Netherlands ) have used allogenic mesenchymal adult stem cells ( eASC ) extracted and expanded from adipose tissue to explore their capacity in treating rheumatoid arthritis.
This eASC based product ( Cx611 ) has been tested in a phase Ib/IIa clinical trial in order to evaluate the safety, tolerability, and optimal dosing, as well as exploring therapeutic activity upon intravenous administration of eASCS in patients with rheumatoid arthritis. T
he Cx611 trial was a multicenter, randomized, single blind, placebo-controlled with 53 patients having active refractory rheumatoid arthritis.
At 6 months, the study met all of its safety endpoints and demonstrated a good safety profile.
Moreover, preliminary results suggest Cx611 has the potential to positively impact disease in refractory patients, showing a clear improvement over placebo over three months and a sustained benefit over six months. ( Xagena )
Dalemans W, Human Gene Therapy, 2013