A Chilean cell-based clinical trial in osteoarthritis reveals the superiority of repetitive MSC injections to Hyaluronic Acid treatment

  • The study, made by the Chilean biotech company Cells for Cells and Universidad de los Andes Clinical Center, was published in STEM CELLS Translational Medicine journal.
  • The work shows that patients with knee osteoarthritis treated with the allogeneic umbilical cord MSC-based therapy branded as CELLISTEM® OA, experienced a significant improvement in pain reduction, increased mobility and decreased stiffness.

Santiago, January 2019

Researchers from Cells for Cells and Universidad de los Andes Clinic, developed a therapy for the symptomatic treatment of osteoarthritis, using mesenchymal cells from umbilical cord stroma.
Between 2015 and 2017, Cells for Cells and its government co-financed research consortium Consorcio Regenero conducted a clinical trial entitled: “Allogeneic Mesenchymal Stromal Cell therapy for knee-OA: A phase I/II randomized controlled trial”. The study design compared the efficacy and safety of CELLISTEM® OA versus hyaluronic acid as a treatment for symptomatic knee osteoarthritis in 30 Chilean patients between 40 and 65 years old.

In terms of pain, CELLISTEM® OA was much superior to Hyaluronic Acid at 6 and 12 months of follow-up. Two doses of CELLISTEM® OA with an interval of 6 months between doses, is the treatment that obtained the greatest benefits, with an 85% of pain reduction.

In terms of joint function, CELLISTEM® OA was also significantly superior to Hyaluronic Acid at 6 and 12 months of follow-up. A dose of CELLISTEM® OA repeated at 6 months had better results, with a relative reduction of 90% joint disability.

The percentage of responder patients measured by the OMERACT-OARSI Responder Index Criteria was also significantly higher with CELLISTEM® OA, obtaining a 100% response in patients who received the treatment twice a year.

Francisco Espinoza, medical director of Cells for Cells and rheumatologist at Universidad de los Andes Clinic, said that the work from many years has the explicit support of the specialized scientific community. In addition, indicated that with the team of researchers “we are encouraged by these results, because they could pave the way for a new non-invasive therapy, which improves the quality of life of a group of patients that currently face very limited therapeutic options.”

The scientific journal STEM CELLS Translational Medicine is one of the journals with the greatest impact in cell therapy, which supports the thoroughness of the clinical trial, the only one of its kind worldwide. This is the second clinical study originated in Chile which uses stem cells, after the publication, on September 2017, of the clinical study RIMECARD, also from Cells for Cells, in the scientific journal Circulation Research Journal of the American Heart Association (AHA).

Before to the study in patients, there was an extensive preclinical research work in the laboratory to support the safety and efficacy of this therapy and to unravel its possible action mechanisms.
For Maroun Khoury, scientific director of Cells for Cells, “the symptomatic improvement of osteoarthritis may be associated not only with the high regenerative capacity and differentiation of cells derived from umbilical cord, but also with its immunoregulatory effect or even with new mechanisms of action that we are still elucidating. Through these factors we can select which cells have a better effect in one or another pathology, such as knee osteoarthritis or heart failure”, he says.

Osteoarthritis of the knee is one of the main causes of pain and disability. While conventional treatments show modest benefits, the aim of this study was to evaluate the safety and efficacy of single or repeated intra-articular injection of mesenchymal cells derived from umbilical cord and selected for their regenerative potential, through an allogenic treatment, that is with stem cells from a donor and not from the same patient.

International recognition

The publication of this clinical trial supports the development of innovative cell therapies and the work Cells for Cells is doing in this field. Cells for Cells set to begin a multicenter Phase III clinical trial with neighboring countries during 2019, while preparing the ground for entering in other geographical regions.

“This is the result of a long-standing work of a team of professionals committed to innovation, which includes research and development of an advanced medical therapy that has clinical support and intellectual property protection. We are very happy and satisfied with this milestone, because we are not only making progress in the area of cell therapy, but we are helping to improve the quality of life of many people who without this therapy would not have many treatment options”, says Roberto Bobadilla, CEO of Cells for Cells and Consorcio Regenero.

 

Clinical trial: “Allogeneic Mesenchymal Stromal Cell therapy for knee-OA: A phase I/II randomized controlled trial”