Sjögren’s syndrome is a serious autoimmune disease that can cause serious eye and vision problems due to reduced tear production.
A phase I trial with direct injection of ASCs into the lacrimal gland has proven safety and efficacy. Based on these data the first of 40 planned patients has been enrolled and treated with ASCs in the double-blind placebo-controlled phase II trial in patients with tear gland malfunction (Aqueous Deficient Dry Eye Disease, Sjögren’s syndrome).
Cell2Cure, as part of the consortium Clinical Stem cell Innovation and production Center (CSIC), receives funding from Innovation Fund Denmark. CSIC embraces late-stage development of ASCs – with an aim to mature process knowledge and product quality as a prerequisite for production up-scale; expand product portfolio and down-stream processing, improve the scientific rationale and complete a clinical dose titrating trial in 30 patients having a lung transplantation, while identifying a feasible regulatory strategy addressing safety, quality and efficacy.
In short, the Center prepares stem cell therapy for pivotal trials, investments, and final market access, bringing stem cells the last important steps to the market and to actually being used by health care systems, for the benefit of patients worldwide. Consortium partners are University Hospital Copenhagen, Sexton Biotechnologies, University of Copenhagen and Cell2Cure and received 25 million DKK in funding.
The clinical phase I trial evaluated the safety and feasibility of injecting allogeneic adipose tissue-derived mesenchymal stromal/stem cells (ASCs) into the lacrimal gland as a treatment of aqueous deficient dry eye disease (ADDE) Sjögrens syndrome.
The trial found injection of allogeneic ASCs produced using Cell2Cure´s patented technology into the lacrimal gland to be safe, feasible and well tolerated in seven patients. A single injection of allogeneic ASCs improved both signs and symptoms in patients with severe ADDE due to either primary or secondary Sjögren’s syndrome.
Full article link
Safety and feasibility of mesenchymal stem cell therapy in patients with aqueous deficient dry eye disease – PubMed
