Belgian company TiGenix is \u200b\u200bdeveloping Cx611 allogeneic stem cells from adipose tissue to be used against rheumatoid arthritis.

Phase 2 Randomized Trial Planned for Early 2015.

The study will include patients with rheumatoid arthritis (RA) who are on corticosteroids and methotrexate but have never been treated with biologics..

The primary endpoint of the study was remission, defined as a Disease Activity Score (DAS28) score in 28 joints below 2.6. Eduardo Bravo, CEO of TiGenix, spoke about this.

“There is a need for treatments with an alternative mechanism of action that could increase the proportion of patients in remission and slow down the slide into long-term and costly biologic therapy,” says Dr. Frank Luyten, Head of Rheumatology at Leuven University Hospital in a press release..

In a letter to MedPage Today, Dr. Luten told MedPage Today that stem cell therapy is about to make a big difference in rheumatology: “I started working as a rheumatologist 30 years ago.. I have seen incredible breakthroughs in the treatment of RA patients, partly due to traditional drugs, partly due to biologics (TNF blockers), partly due to new treatment strategies - personal risk identification, predicting response to therapy, targeted treatment, multidisciplinary approach, personalized therapy and more. All these and many other concepts have become firmly established in clinical practice and continue to be updated, changing the face of rheumatology in the 21st century..

Luten has high hopes for stem cell therapy: “Many patients today remain functional, both in their personal and professional lives.. There is hope that Cx611, a drug with a wide range of immunomodulatory effects, can extinguish the pathological process, reduce it to a minimum.. This will help even those patients who respond poorly to glucocorticoids and disease-modifying drugs (DMARDs).”.

“Cx611 cell preparation has a wide range of immunomodulatory properties, such as interaction with B cells, T cells and macrophages. As a result, stem cells regain control of the pro-inflammatory environment,” says Wilfried Dalemans, chief technical consultant at TiGenix..

In vitro, stem cells have demonstrated the ability to induce regulatory T cells and suppress synoviocytes, a major source of inflammatory mediators in RA..

An early Phase 1B/2A study presented last year at the American College of Rheumatology meeting in San Diego examined the safety and tolerability of. At that time, a certain effectiveness of Cx611 had already been demonstrated..

The study, conducted by the team of Dr. Jose Maria Alvaro-Gracia from Madrid, included 53 patients who suffered from RA for an average of 13 years.. All participants previously received traditional DMARDs and at least 2 biologics, continued to maintain moderate daily activity, DAS28 score was 3.2.

Participants received three infusions of 1 x 106, 2 x 106 or 4 x 106 stem cells or placebo. The procedures were performed on the 1st, 8th and 15th day of the study. Cohort A, which received the lowest dose of the drug, showed the best clinical response..

Regarding the safety of the drug, Alvaro-Grazia notes that only three serious side effects have been recorded (lacunar cerebral infarction, fever of unknown origin and peroneal paresis).. Of these, scientists associate only lacunar infarction with the drug.; the patient stopped treatment and recovered completely.

Other more common side effects included fever, headache, urinary tract infections, upper respiratory tract infections, nausea.

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medbe. en.