Publication details
Zpráva o průběhu klinického hodnocení MSC-EB období 12. října 2023 - 11. října 2024
| Title in English | Report on the progress of the MSC-EB clinical trial for the period October 12, 2023 - October 11, 2024 |
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| Year of publication | 2024 |
| Type | Research report |
| MU Faculty or unit | |
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| Description | Safety and efficacy of allogeneic mesenchymal stromal cells derived from adipose tissue in patients with epidermolysis bullosa: a phase I/II clinical trial MSC-EB is a phase I/II clinical trial that aims to evaluate the safety and efficacy of administering a medicinal product based on mesenchymal stromal cells in patients with the rare congenital (genetic) disease epidermolysis bullosa (butterfly wing disease). In the first phase of the study, the medicinal product will be administered to adult patients, and in the second phase, to children with this disease. The medicinal product was developed and is manufactured by the CZECRIN GMP unit ACIU MU. It is based on specialized cells isolated from the adipose tissue of healthy donors. These cells are present in every person's body, where they serve to repair damaged tissues and influence the functions of the immune system - they are able to naturally suppress the exaggerated inflammatory reaction that occurs even in difficult-to-heal skin wounds. Administration of mesenchymal stromal cells could accelerate the healing of chronic wounds in patients with butterfly wing disease. Patients participating in the study are under the care of the principal investigator, MUDr. Jitka Vokurková, Ph.D. and her colleagues from the Department of Burns and Plastic Surgery and MUDr. Hana Bučková, Ph.D. and her colleagues from the Pediatric Dermatology Department/EB Center of the Brno University Hospital. The patient organization DEBRA ČR, z. ú., has also been involved in the development of the product and the implementation of the study from the beginning. |