Novel cell therapy FCR001, was developed by Talaris for the treatment of patients with diffuse systemic sclerosis (SSc), a severe form of the rare autoimmune disease scleroderma.
Scleroderma, a rare and potentially fatal chronic autoimmune disease causes progressive scarring, or fibrosis, in the body’s connective tissues. Systemic scleroderma, also called systemic sclerosis (SSc) affects the skin and vital internal organs, especially the lungs, kidneys, gut and heart, resulting in organ dysfunction.
It is believed that FCR001 serve as a new treatment option for patients suffering with diffuse cutaneous systemic sclerosis, a subset of scleroderma with high morbidity and mortality. In addition, for individuals who need great need of safe and effective, disease-modifying, treatment, FCR001 would be the better option.
FCR001 is an investigational, allogeneic cell therapy developedto induce or restore patients’ immune tolerance.
Investigational New Drug (IND) FCR001has received both Orphan Drug Designation and Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration.
