Cellcolabs Announces Supply of Mesenchymal Stem Cells for Phase I Clinical Trial in Sjögren’s Syndrome
Stockholm, Sweden / Copenhagen, Denmark:
Cellcolabs AB, a Swedish biotechnology company specializing in the industrial-scale production of investigational advanced therapy medicinal products (iATMPs), is proud to announce its involvement as a supplier of GMP manufactured aMSCs (adipose-derived mesenchymal stem cells) in a Phase I clinical trial at Rigshospitalet, Copenhagen. The trial will assess the safety and indicative efficacy of aMSCsfor treating xerostomia, a hallmark symptom of Sjögren’s Syndrome.
The double-blinded trial, which will enrol 40 patients, marks the first clinical use of Cellcolabs’ adipose-derived Mesenchymal Stem Cells in Denmark. The first patient was successfully treated in winter 2025.
Sjögren’s Syndrome is a chronic autoimmune disorder characterized by immune cell infiltration into exocrine glands, leading to glandular dysfunction and xerostomia.1 Current treatments are limited, highlighting the need for new therapeutic options. MSCs possess anti-inflammatory, immunomodulatory and regenerative properties, 2 making them a promising candidate for immune-mediated conditions like Sjögren’s Syndrome.
The primary objective of this study is to assess the efficacy of aMSC injections in the submandibular glands versus placebo on unstimulated whole saliva flow rate (UFR) in patients with pSS-related xerostomia. Secondary endpoints include changes in stimulated saliva flow (SFR), salivary composition, safety (SAEs, AEs, mortality), patient-reported outcomes, immune response, gland morphology (OMERACT ultrasound), and disease activity (ESSDAI, ESSPRI).
“We’re very proud of our collaboration with Rigshospitalet for this trial” said Dr. Mattias Bernow, CEO of Cellcolabs. “It’s an important opportunity to explore how Mesenchymal Stem Cells can offer new possibilities for treating conditions like Sjögren’s Syndrome, and we look forward to seeing the potential impact of this research.”
About Cellcolabs
Cellcolabs is a Swedish biotech company that specialises in industrial-scale production of mesenchymal stem cells. Cellcolabs’ mission is to prevent and treat diseases by making high quality stem cells available and affordable through industrial scale production and collaborations. The MSCs produced at Cellcolabs follow the same production protocol that has been developed by the Karolinska Institute for over 20 years. Cellcolabs was founded in 2021 and is led by CEO Dr. Mattias Bernow. The company’s investors include Norrsken Foundation and prominent angel investors such as Avito founders Jonas Nordlander and Filip Engelbert.
Media Contact:
Cellcolabs Communications Team
Email: press@cellcolabs.com
Website: www.cellcolabs.com
- Negrini S, Emmi G, Greco M, et al. Sjögren’s syndrome: a systemic autoimmune disease. Clinical and Experimental Medicine. 2022;22(1):9-25. doi:https://doi.org/10.1007/s10238-021-00728-6
- Lynggaard CD, Jersie-Christensen R, Juhl M, et al. Intraglandular mesenchymal stem cell treatment induces changes in the salivary proteome of irradiated patients. Communications Medicine. 2022;2(1). doi:10.1038/s43856-022-00223-3