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News
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2022 Jul
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2022 JulOur daughter company RHEACELL is present at the following events:
Annual meeting of the interest group Epidermolysis Bullosa e.V. DEBRA Germany from 2nd to 4th September 2022 in Rotenburg a.d. Fulda
3rd WundD.A.CH three-country congress from 29th September to 1st October 2022 in Stuttgart
64th Annual Conference of the German Society for Phlebology from 29th September to 1st October 2022 in Hannover
2022 Diabetic Lower Extremity Symposium from 3rd to 4th November in Boston, MA, USA
IWC (Interdisciplinary Wound Congress) on 24th of November 2022 in Cologne
05th Nuremberg Wound Congress from 1st to 2nd December 2022 in Nuremberg -
2021 OctFollow-up study with highly purified stem cells.
Our daughter company 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.
Our daughter company RHEACELL has been granted national marketing authorization (§ 4b of the German Medicinal Products Act) in Germany 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 RHEACELL´s Epidermolysis Bullosa program, bringing our daughter company 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 successfully concludes Phase IIa clinical trial with ABCB5-positive stem cells.
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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.
Scientific papers
- 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
- Ksander et. al. ABCB5 is a limbal stem cell gene required for corneal development and repair. Nature 2014;511:353-357