OA represents a complex musculoskeletal disorder with multiple genetic, constitutional, and biomechanical risk factors. It represents the most common form of joint disease and disability in older people and ranks amongst the top 5 causes of disability. Current treatment options result in poor clinical outcome without any effect on the cartilage degeneration progress.
Recently, human case studies suggest that intra-articular Mesenchymal stem cells (MSC) injection could be a useful therapeutic alternative for treating knee osteoarthritis. The main principle characteristics of stem cells (the ability to self-renew and to differentiate along multiple lineages and their paracrine effect) make them an attractive alternative for the treatment of age-related disorders that involve more than one tissue, such as degenerative joint diseases and arthritis. Several studies have proved that patients can remain free of symptoms for a period up to two years meanwhile MRI examination indicates an improvement of cartilage quality.
The product in development is a biological treatment which will be used to delay the disease progression by creating the optimum environment within the cartilage which will enhance the action of endogenous (synovial) stem cells.
The product consists of two active components that act in a complementary way in order to delay or even stop the progression of osteoarthritis. These components are Hyaluronic Acid, and a Proliferation Mix. Intellectual property patent has been submitted.
The mesenchymal stem cells that can be used as targets of the action of the product are the endogenous (synovial) stem cells that already reside within the joint and their number and function has been significantly altered by the disease.
The product has first of all an immediate effect, by improving the mechanical function of the joint through a decrease in the fictional forces within the joint. Thus, an immediate pain reduction will be observed.
At the same time, the Proliferation Mix demonstrates a long-term effect, by leading to an improvement of the synovial environment. This, in turn, enhances the function of the synovial stem cells and increases their number so that they can exert their immunomodulatory, paracrine and cartilage regeneration effect.
Currently TC-MD-02141 is in a preclinical phase and is estimated to enter in Phase I studies the third quarter 2015.