The European Medicines Agency (EMA) has approved the pediatric investigation plan for RHEACELL´s Epidermolysis Bullosa program, bringing our daughter company one step closer to filing for marketing authorization.
News
-
2020 SepRequested for the national marketing authorization in Germany.
Based on convincing clinical results (I/IIa) in the indication of non-healing chronic venous ulcers (CVU), RHEACELL filed for national marketing authorization in Germany (special provisions governing advanced therapy medicinal products).
-
2020 SepChronic Venous Ulcers (CVU): Phase I/IIa clinical study for chronic venous ulcers successfully completed.
Heidelberg-based biopharmaceutical company demonstrates efficacy and safety of ABCB5-positive stem cells in CVU patients in clinical phase IIa trial.
-
2020 AugDiabetic Foot Ulcer (DFU): Phase I/IIa clinical study for chronic venous ulcers successfully completed.
Heidelberg-based biopharmaceutical company demonstrates safety and efficacy of ABCB5-positive stem cells in Phase IIa clinical trial.
-
2020 AugEpidermolysis Bullosa (EB): Phase I/IIa clinical study successfully completed.
Heidelberg-based biopharmaceutical company successfully concludes Phase IIa clinical trial with ABCB5-positive stem cells.
-
2020 JulyRHEACELL successfully concludes three phase I/II a clinical trials for chronic and incurable diseases at once.
Biopharma company completes three registered somatic cell therapy clinical trials for severe, chronic diseases.
-
2019 AprEpidermolysis Bullosa (EB): Orphan Drug Designation from FDA and EMA granted.
The medicinal drug product tested in international phase I/IIa clinical trial has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
-
2019 MarLimbal Stem Cell Deficiency (LSCD): Orphan Drug Designation from FDA and EMA granted.
LSCD acquired Fast Track Designation from FDA.The medicinal drug product tested in international phase I/IIa clinical trial has been granted Orphan Drug Designation from the FDA and the European Medicines Agency) and Fast Track Designation from the FDA for the treatment of LSCD.
Scientific papers
- Watanabe et. al. Human iPS cells engender corneal epithelial stem cells with holoclone-forming capabilities. iScience, 2021; doi: 10.1016/j.isci.2021.102688
- Norrick et. al. Process development and safety evaluation of ABCB5+ limbal stem cells as advanced-therapy medicinal product to treat limbal stem cell deficiency. Stem Cell Res Ther 2021;12:194
- Harrell et. al. The role of Interleukin 1 receptor antagonist in mesenchymal stem cell-based tissue repair and regeneration. BioFactors. 19 October 2019
- Jiang et. al. Mesenchymal Stem Cells Adaptively Respond to Environmental Cues Thereby Improving Granulation Tissue Formation and Wound Healing. Front. Cell Dev. Biol., 29 July 2020
- Riedl et al. ABCB5+ dermal mesenchymal stromal cells with favorable skin homing and local immunomodulation for Recessive Dystrophic Epidermolysis Bullosa treatment. Stem Cells 2021
- Kerstan et al. Ex-vivo expanded highly pure ABCB5+ mesenchymal stromal cells as GMP-conform autologous ATMP for clinical use: Process validation and first-in-human data. Cytotherapy 2021;23:165-175
- Ballikaya et al. Process data of allogeneic ex vivo-expanded ABCB5+ mesenchymal stromal cells for human use: Off-the-shelf GMP-manufactured donor-independent ATMP. Stem Cell Res Ther 2020;11:482
- Klicks et al. A novel spheroid-based co-culture model mimics loss of keratinocyte differentiation, melanoma cell invasion, and drug-induced selection of ABCB5-expressing cells. BMC Cancer 2019;19:402
- Hartwig et al. Human skin derived ABCB5+ stem cell injection improves liver disease parameters in Mdr2KO mice. Arch Toxicol 2019;93:2645-2660
- Vander Beken et al., Newly Defined ATP-Binding Cassette Subfamily B Member 5 Positive Dermal Mesenchymal Stem Cells Promote Healing of Chronic Iron-Overload Wounds via Secretion of Interleukin-1 Receptor Antagonist. Stem Cells 2019;37:1057–1074
- Tappenbeck et al. In vivo safety profile and biodistribution of GMP-manufactured human skin-derived ABCB5-positive mesenchymal stromal cells for use in clinical trials. Cytotherapy 2019;21:546-560
- Notara et al. UV light-blocking contact lenses protect against short-term UVB-induced limbal stem cell niche damage and inflammation. Sci Rep 2018;8:12564
- Tietze et al. Assessment of the hepatocytic differentiation ability of human skin-derived ABCB5+ stem cells. Exp Cell Res 2018;369:335-347
- Borchers et al. Detection of ABCB5 tumour antigen-specific CD8+ T cells in melanoma patients and implications for immunotherapy. Clin Exp Immunol 2017;191:74-83
- Webber et al. Rapid generation of Col7a1−/− mouse model of recessive dystrophic epidermolysis bullosa and partial rescue via immunosuppressive dermal mesenchymal stem cells. Lab Invest 2017;97:1218-1224
- Ksander et. al. ABCB5 is a limbal stem cell gene required for corneal development and repair. Nature volume 511, pages353–357(2014)