DDG-Tagung from 30th of April to 3rd of May 2025 Berlin, Germany
DEWU Deutscher Wundkongress from 7 th to 9th of May 2025 in Bremen, Germany
4th WundD.A.CH three-country congress from 23rd to 24th of June 2025 in Freiburg, Germany
News
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2024 NovFirst study center in the UK
Fantastic news! The first study center for our pivotal phase III study on therapy-resistant chronic venous ulcers has now officially been activated! We are thrilled to have Mark Whiteley as the Principal Investigator, and we are excited that The Whiteley Clinic is now part of this important study.
A huge thank you to FGK Clinical Research GmbH for their invaluable support in bringing this project to life!
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2024 SepRHEACELL announces FDA approval for Phase 3 study in refractory, non-curable CVU
For the press release click here
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2024 SepEB trial published in Argentinean Newspaper
The article outlines that this is Argentina's first study involving stem cell therapy, marking a significant milestone for the country. It also highlights the treatment of the first patient and informs that they plan to enroll at least 15 more patients in the study.
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2024 MarIndependent KoPra press conference by DDG and BVDD on March 01, 2024
Therapies with human stem cells for chronic venous leg ulcers ("open leg").
You can find the video summary HERE.
Source: German Dermatological Society e.V. (DDG) - https://derma.de/presse -
2024 FebResearch Success in Rare Disease
RHEACELL receives positive signal for accelerated stem cell development program in rare ‚Butterfly Disease‘
For the press release click here
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2023 JunStem cell therapy for "butterfly disease"
RHEACELL announces "First Patient In": EB-Haus in Salzburg, Austria starts pivotal study for stem cell therapy for severe forms of Epidermolysis bullosa that is longed for by those affected.
For the press release click here
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2023 Feb"Kooperationspreis Wissenschaft-Wirtschaft 2022" from Ulm University
Professor Dr. med. Karin Scharffetter-Kochanek, Dr. Christoph Ganss and Dr. Andreas Kluth from RHEACELL received the "Kooperationspreis Wissenschaft-Wirtschaft 2022" from Ulm University.
For the press release click here (only in German)
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2022 NovStem cell therapy for "Butterfly disease"
RHEACELL receives "Partners in Progress Award" from debra of America for Epidermolysis Bullosa research.
For the press release click here
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2022 Jul
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2021 DecRHEACELL's cell therapy product AMESANAR® is now listed on the website of Germany's Federal Institute for Vaccines and Biomedicines (competent authority)
It is only the second authorized "Somatic Cell Therapy Medicinal Product".
For more information click here
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2021 OctFollow-up study with highly purified stem cells
RHEACELL is conducting a follow-up study with highly purified stem cells for the treatment of previously incurable chronic ulcers.
For the press release click here
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2021 SepNational marketing authorization in Germany for novel cell therapy
RHEACELL has been granted national marketing authorization in Germany (§ 4b of the German Medicinal Products Act) for its’ cell therapy product AMESANAR®, produced by TICEBA, for the use in patients with chronic wounds.
For the press release click here
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2021 JunPediatric Investigation Plan (PIP) approved by PDCO (EMA)
The European Medicines Agency (EMA) has approved the pediatric investigation plan for our Epidermolysis Bullosa program, bringing us one step closer to filing for marketing authorization.
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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).
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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.
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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.
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2020 AugEpidermolysis Bullosa (EB): Phase I/IIa clinical study successfully completed
Heidelberg-based biopharmaceutical company demonstrates safety and efficacy of ABCB5-positive stem cells in Phase IIa clinical trial.
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2020 JulRHEACELL 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.
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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).
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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.
Recent scientific papers
- Niebergall-Roth et al. Systemic treatment of recessive dystrophic epidermolysis bullosa with mesenchymal stromal cells: a scoping review of the literature and conclusions for future clinical research. J Dermatol Treat 2024;35:2419931
- Meshko et. al, Anti-Inflammatory and Anti-(Lymph)angiogenic Properties of an ABCB5+ Limbal Mesenchymal Stem Cell Population, Int. J. Mol. Sci. 2024, 25(17), 9702
- Sadeghi et al. Potency assay to predict the anti-inflammatory capacity of a cell therapy product for macrophage-driven diseases: Overcoming the challenges of assay development and validation. Cytotherapy 2024;26:512-523
- Rendra et al. Clinical-grade human skin-derived ABCB5+ mesenchymal stromal cells exert anti-apoptotic and anti-inflammatory effects in vitro and modulate mRNA expression in a cisplatin-induced kidney injury murine model. Front Immunol 2023;14:1228928
- Schröder et al. Drug regulatory-compliant validation of a qPCR assay for bioanalysis studies of a cell therapy product with a special focus on matrix interferences in a wide range of organ tissues. Cells 2023;12:1788
- Meshko et al. ABCB5+ limbal epithelial stem cells inhibit developmental but promote inflammatory (lymph) angiogenesis while preventing corneal inflammation. Cells 2023;12:1731
- Niebergall-Roth et al. Kinetics of Wound Development and Healing Suggests a Skin-Stabilizing Effect of Allogeneic ABCB5+ Mesenchymal Stromal Cell Treatment in Recessive Dystrophic Epidermolysis Bullosa. Cells 2023;12:1468
- Dieter et al. ABCB5+ mesenchymal stromal cells facilitate complete and durable wound closure in recessive dystrophic epidermolysis bullosa. Cytotherapy 2023;25:782-788
- Yan et al. ABCB5+ mesenchymal stromal cells therapy protects from hypoxia by restoring Ca2+ homeostasis in vitro and in vivo. Stem Cell Res Ther 2023;14:24
- Niebergall-Roth et al. Skin-derived ABCB5+ mesenchymal stem cells for high-medical-need inflammatory diseases: from discovery to entering clinical routine. Int J Mol Sci 2023;24:66
- Domdey et al. Consecutive dosing of UVB irradiation induces loss of ABCB5 expression and activation of EMT and fibrosis proteins in limbal epithelial cells similar to pterygium epithelium. Stem Cell Res 2022;64:102936
- Kerstan et al. Translational development of ABCB5+ dermal mesenchymal stem cells for therapeutic induction of angiogenesis in non-healing diabetic foot ulcers. Stem Cell Res Ther 2022;13:455
- Nardozi et al. Potential therapeutic effects of long-term stem cell administration: impact on the gene profile and kidney function of PKD/Mhm (Cy/+) rats. J Clin Med 2022;11:2061
- Singh et al. Angiogenin Released from ABCB5+ Stromal Precursors Improves Healing of Diabetic Wounds by Promoting Angiogenesis. J Invest Dermatol 2022;142:1725-1736
- Kerstan et al. Allogeneic ABCB5+ mesenchymal stem cells for treatment-refractory chronic venous ulcers: a phase I/IIa clinical trial. JID Innovations 2022;2:100067
- Kiritsi et al. Clinical trial of ABCB5-positive mesenchymal stem cells for recessive dystrophic epidermolysis bullosa. JCI Insight 2021;6:e151922
- Watanabe et al. Human iPS cells engender corneal epithelial stem cells with holoclone-forming capabilities. iScience 2021;24:102688
- 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. 2020;46:263-275
- Jiang et al. Mesenchymal Stem Cells Adaptively Respond to Environmental Cues Thereby Improving Granulation Tissue Formation and Wound Healing. Front Cell Dev Biol 2020;8:697
- Riedl et al. ABCB5+ dermal mesenchymal stromal cells with favorable skin homing and local immunomodulation for Recessive Dystrophic Epidermolysis Bullosa treatment. Stem Cells 2021;39:897-903
- 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
- Schatton et al. ABCB5 identifies immunoregulatory dermal cells. Cell Rep. 2015 Sep 8; 12(10): 1564–1574
- Ksander et al. ABCB5 is a limbal stem cell gene required for corneal development and repair. Nature 2014;511:353-357
You will find more scientific papers by following this link.