Germany's Federal Institute for Vaccines and Biomedicines (Paul-Ehrlich-Institut) grants RHEACELL national approval for its cell therapy product AMESANAR(R) for the use in patients with chronic wounds
HEIDELBERG, GERMANY / ACCESSWIRE / October 6, 2021 / Chronic wounds not only put great strain on the health system, but also have a major impact on the quality of life of affected patients.
RHEACELL, a German biopharmaceutical company focused on clinical development of novel stem cell therapeutics, has been granted national approval under 4b of the German Medicinal Products Act for its novel cell therapy product AMESANAR(R). AMESANAR(R) (allogeneic ABCB5-positive mesenchymal stromal cells), manufactured by TICEBA GmbH from donor skin, is an Advanced Therapy Medicinal Product (ATMP) and can be used in patients with chronic wounds caused by chronic venous insufficiency.
The approval represents a major advance for those affected, as well as an important milestone for biopharmaceutical industry efforts directed at the development of cell-based drugs: This first approval of a somatic cell therapy medicinal product derived from skin validates the concept that translation of highly innovative cell therapies to clinical use is achievable. Currently RHEACELL is preparing for market entry in Germany. AMESANAR(R) will be available to patients at hospitals and specialized clinics in Germany.
RHEACELL's ongoing clinical development programs focus not only on chronic wounds, but also on additional serious or rare diseases such as epidermolysis bullosa (butterfly disease), which mainly affects children.
RHEACELL hopes to alleviate the suffering of affected patients by concentrating on the development of cell therapies for rare diseases and diseases where no cure is available.
Press contact for RHEACELL:
Dr. Christoph GanssRHEACELL GmbH & Co. KGIm Neuenheimer Feld 51769120 Heidelberg, GermanyT +49 6221 71833-0F +49 6221 71833-291E media@rheacell.comW http://www.rheacell.com
RHEACELL GmbH & Co. KG
RHEACELL is dedicated to drug development based on anti-inflammatory ABCB5-positive mesenchymal stem cells. A key component of RHEACELL's research program is developing new and innovative therapy approaches and testing them in clinical trials. The aim is that patients have new therapy options for previously untreatable or insufficiently treatable diseases.
RHEACELL is the world-wide exclusive licensee for all patents surrounding ABCB5 held by Boston Children's Hospital, a teaching affiliate of Harvard Medical School, Boston, Massachusetts. Dr. Markus Frank, Associate Professor of Pediatrics and Dermatology, Harvard Medical School and discoverer and leading expert on ABCB5, is acting as a scientific adviser to RHEACELL.
RHEACELL is conducting several national and international multicenter clinical trials. RHEACELL holds orphan drug designation through the European Medicines Agency (EMA) and the United States Federal Drug Administration (FDA) for the treatment of epidermolysis bullosa (EB) and limbal stem cell deficiency (LSCD). RHEACELL has also received the "Fast Track Status" for treatment of LSCD from the FDA. The EMA's PDCO has also approved the pediatric investigation plan for RHEACELL's Epidermolysis Bullosa program.
RHEACELL GmbH & Co. KG is a joint venture between Mller Holding (Ulm, Germany) and TICEBA GmbH (Heidelberg, Germany). RHEACELL's development program is supported by Mller and by TICEBA's know-how.
TICEBA - the parent company of RHEACELL - is pioneering the production of ABCB5-positive (ABCB5+) mesenchymal stem cells in accordance with the highest pharmaceutical quality standards - the AMG: German Medicinal Products Act - with more than 15 years of expertise in the field of advanced stem cell research and regenerative medicine - paving the way to the patient for its innovative stem cell therapeutics (ATMP).
RHEACELL GmbH & Co. KGIm Neuenheimer Feld 51769120 Heidelberg, GermanyT +49 6221 71833-0F +49 6221 71833-291E media@rheacell.comW http://www.rheacell.com
SOURCE: RHEACELL GmbH & Co. KG
View source version on accesswire.com:https://www.accesswire.com/666987/Germany-Approves-Novel-Cell-Therapy-Extracted-from-Skin
Continue reading here:
Germany Approves Novel Cell Therapy Extracted from Skin - BioSpace
- Mesenchymal stem cell based therapies for uveitis: a systematic review of preclinical studies | Eye - Nature.com - April 10th, 2024
- Development of exosome therapy to treat inflammatory bowel disease by VesiCURE Therapeutics - StreetInsider.com - April 10th, 2024
- Adipose Derived Stem Cell Therapy Market Will Show the Highest Growth Rates, Incredible Demand by 2031 - WhaTech - April 3rd, 2024
- Injectable microspheres adhering to the cartilage matrix promote rapid reconstruction of partial-thickness cartilage defects - ScienceDirect.com - March 30th, 2024
- Safety and Potential Effect of Intrauterine Infusion of Autologous Adipose Tissue-Derived Regenerative Cells in ... - Cureus - March 30th, 2024
- Instructing iPS cell-derived mesenchymal stem cells to inhibit abnormal bone formation in FOP - Medical Xpress - March 28th, 2024
- Clinical application of mesenchymal stem cell in regenerative medicine ... - March 22nd, 2024
- Mesenchymal Stem Cells: The Past Present and Future - March 22nd, 2024
- CytoMed Diversifies into Regenerative Medicine after Research Collaboration with Singapore's Sengkang General ... - Yahoo Finance - March 20th, 2024
- Overexpression of Wnt5a promoted the protective effect of mesenchymal stem cells on Lipopolysaccharide-induced ... - BMC Infectious Diseases - March 20th, 2024
- Mesenchymal Stem Cells: What We Have Learned and How to Manage Them - MDPI - March 17th, 2024
- Mesenchymal stem cells and their microenvironment - March 17th, 2024
- Mesenchymal stem/stromal cells as a valuable source for the treatment ... - March 17th, 2024
- Proteomic characterization of hUC-MSC extracellular vesicles and evaluation of its therapeutic potential to treat ... - Nature.com - March 13th, 2024
- The impact understanding of exosome therapy in COVID-19 and preparations for the future approaches in dealing with ... - Nature.com - March 13th, 2024
- CytoMed Therapeutics Limited Announces Research Collaboration with Singapore Sengkang General Hospital to ... - Yahoo Finance UK - March 7th, 2024
- CytoMed Therapeutics Limited Announces Research Collaboration with Singapore Sengkang General Hospital to ... - Yahoo Finance - March 6th, 2024
- Combatting osteoarthritis with cartilage replacement therapy - Drug Target Review - March 3rd, 2024
- Ethical considerations in Stem Cell therapy for ALS - Cyprus Mail - February 27th, 2024
- Therapeutic Solutions International Files Patent on Facilitating Effects of JadiCells on Gene Therapy Mediated Cell ... - Business Wire - February 27th, 2024
- Stem Cell Therapy for Ulcerative Colitis - Health Central - February 27th, 2024
- Expanding the Horizons of Cell and Gene Therapy - RegMedNet - February 24th, 2024
- Early differentiation of mesenchymal stem cells is reflected in their dielectrophoretic behavior | Scientific Reports - Nature.com - February 22nd, 2024
- Orthopaedics Department's Regenerative Research Highlighted at ORS Annual Meeting - InventUM - University of Miami - February 20th, 2024
- Cellular uptake and in vivo distribution of mesenchymal-stem-cell-derived extracellular vesicles are protein corona ... - Nature.com - February 18th, 2024
- New University spin-out developing novel adult stem cell-based Therapies - News - University of Liverpool - News - February 15th, 2024
- Examining the potential of the common bovine as a potential therapeutic research model - Medical Xpress - February 15th, 2024
- Intentional Interference: Genetic Engineering Medium Aids The Transfection Of MSCs With siRNA - BioProcess Online - February 15th, 2024
- Cellular senescence is associated with osteonecrosis of the femoral head while mesenchymal stem cell conditioned ... - Nature.com - February 9th, 2024
- Stem Cell Therapy for Crohns Disease Shows Promising Results - RegMedNet - February 9th, 2024
- Targeted transcriptomic analysis of synovial tissues from horses with septic arthritis treated with immune-activated ... - American Veterinary Medical... - February 7th, 2024
- Mesenchymal Stem Cell Immunomodulation: Mechanisms and ... - Cell Press - February 7th, 2024
- New Cell Therapy for ARDS: A Groundbreaking Development and Other Respiratory Health Breakthroughs - Medriva - February 7th, 2024
- Effective treatment of optic neuropathies by intraocular delivery of MSC-sEVs through augmenting the G-CSF ... - pnas.org - January 31st, 2024
- Global Stem Cell Therapy Industry Outlook to 2028, Driven by Therapeutic Innovations and Clinical Advancements ... - Yahoo Finance - January 29th, 2024
- Out-of-this-world study will test how stem cells function in space - YP - January 29th, 2024
- The Applications of Cell Therapy - Technology Networks - January 26th, 2024
- STEM CELL THERAPY FOR MS COST: WHAT YOU NEED TO KNOW? - Island Echo - January 24th, 2024
- Understanding Neuromyelitis Optica: Role of NF-B and Therapeutic Potential - Medriva - January 20th, 2024
- Faculty member Arnold Caplan passes away The Daily The Daily - The Daily | Case Western Reserve University - January 18th, 2024
- Effects of fine particulate matter on bone marrow-conserved hematopoietic and mesenchymal stem cells: a systematic ... - Nature.com - January 11th, 2024
- Expression of HLA-DR by mesenchymal stromal cells in the platelet lysate era: an obsolete release criterion for MSCs ... - Journal of Translational... - January 11th, 2024
- NurOwn and its exosomes for ALS given patents in Europe, elsewhere - ALS News Today - January 8th, 2024
- Single-cell analysis reveals the stromal dynamics and tumor-specific characteristics in the microenvironment of ovarian ... - Nature.com - January 8th, 2024
- First in Class Combination Stem Cell and Exosome Therapy to Treat Pulmonary Fibrosis in Long Haul Covid Patients ... - Yahoo Finance - January 4th, 2024
- Choosing the Right Excipients for MSC and iPSC Therapies - Pharmaceutical Technology Magazine - January 4th, 2024
- Mitochondria Transplantation Therapy It's Farther Along Than You Think - BioProcess Online - January 2nd, 2024
- Embryonic-stem-cell-derived mesenchymal stem cells relieve experimental contact urticaria by regulating the functions ... - Nature.com - December 21st, 2023
- Type I collagen and fibromodulin enhance the tenogenic phenotype of hASCs and their potential for tendon ... - Nature.com - December 19th, 2023
- Could the 'central dogma' of biology be misleading bioengineers? - Phys.org - December 13th, 2023
- The Risks of Stem Cell and Exosome Treatments for Long COVID: A Call for Stricter Regulations - Medriva - December 13th, 2023
- Mesenchymal stem cells from biology to therapy - PMC - December 11th, 2023
- The Safety and Efficacy of Human Umbilical Cord-Derived ... - Cureus - December 5th, 2023
- The pivotal role of Nrf2 signal axis in IDD | JIR - Dove Medical Press - December 5th, 2023
- Futuristic Novel Therapeutic Approaches in the Treatment of ... - Cureus - December 3rd, 2023
- Cartilage's Contribution in Otology: A Comprehensive Review of Its ... - Cureus - December 3rd, 2023
- Mesenchymal stem or stromal cells: a review of clinical applications ... - November 29th, 2023
- Comparative evaluation of 3D-printed and conventional implants in ... - Nature.com - November 29th, 2023
- Expression of E-cadherin and N-cadherin in Epithelial-to ... - Cureus - November 29th, 2023
- Enhancing the immunosuppressive properties of human umbilical cord mesenchymal stem cells - Phys.org - November 29th, 2023
- 'Great Potential' in Stem Cell Therapies for Knee Osteoarthritis ... - Pain News Network - November 25th, 2023
- Dietary Sources, Bioavailability, and Functions of Ascorbic Acid ... - Cureus - November 25th, 2023
- FY 2024 VA-Funded Projects - VA's Office of Research and Development - November 25th, 2023
- Real-world data suggest effectiveness of the allogeneic ... - Journal of Translational Medicine - November 23rd, 2023
- Mesenchymal Stem Cells: Characteristics, Function, and Application - November 23rd, 2023
- Combined application of therapeutic viruses and nanomaterials to ... - News-Medical.Net - November 23rd, 2023
- Progress in the Development of Stem Cell-Derived Cell-Free ... - Dove Medical Press - November 23rd, 2023
- Improving the therapeutic efficacy of oncolytic viruses for cancer ... - Journal of Translational Medicine - November 23rd, 2023
- 11.22.23 -- How To Lose A Batch In 10 Days - BioProcess Online - November 23rd, 2023
- The Pros and Cons of Mesenchymal Stem Cell-Based Therapies - November 19th, 2023
- Leptin's influence on MMP-1 expression | JIR - Dove Medical Press - November 15th, 2023
- TWIST1 and TSG6 are coordinately regulated and function as ... - Science - November 11th, 2023
- Association between severe acute malnutrition in childhood and ... - BioMed Central - November 11th, 2023
- Global Market for Treatments for Syndromes of Progressive Ataxia and Weakness Disorders - Yahoo Finance - November 11th, 2023
- Stem Cell Restore Reviews - Does It Work? Real Green Valley ... - The Daily World - November 11th, 2023
- Biological and genetic characterization of a newly established ... - Nature.com - November 11th, 2023
- Placental Stem Cell Collection and Storage Industry Scope ... - Argyle Report - November 9th, 2023
- In Vitro Evaluation of Light-Induced Cytotoxic Property: Synergistic ... - Cureus - November 9th, 2023
- UF professor launches nonprofit to equalize cell-based therapy access - Mainstreet Daily News Gainesville - November 7th, 2023
- Who are the leading innovators in cell immunomodulation for the ... - Pharmaceutical Technology - November 7th, 2023
Recent Comments