Cargando…

From discovery to approval of an advanced therapy medicinal product-containing stem cells, in the EU

In 1997, the human corneal epithelium was reconstructed in vitro and transplanted on patients. Later, it became a routine treatment, before regulations considered advanced therapy medicinal products and drugs on the same lines. Manufacturing, before and after good manufacturing practice setting, was...

Descripción completa

Detalles Bibliográficos
Autores principales:	Pellegrini, Graziella, Lambiase, Alessandro, Macaluso, Claudio, Pocobelli, Augusto, Deng, Sophie, Cavallini, Gian Maria, Esteki, Roza, Rama, Paolo
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Future Medicine Ltd 2016
Materias:	Review
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5561870/ https://www.ncbi.nlm.nih.gov/pubmed/27091398 http://dx.doi.org/10.2217/rme-2015-0051

Ejemplares similares

Location and Clonal Analysis of Stem Cells and Their Differentiated Progeny in the Human Ocular Surface
por: Pellegrini, Graziella, et al.
Publicado: (1999)

SOX2 Is a Univocal Marker for Human Oral Mucosa Epithelium Useful in Post-COMET Patient Characterization
por: Attico, Eustachio, et al.
Publicado: (2022)

Comparison between Cultivated Oral Mucosa and Ocular Surface Epithelia for COMET Patients Follow-Up
por: Attico, Eustachio, et al.
Publicado: (2023)

Clinical development time is shorter for new anticancer drugs approved via accelerated approval in the US or via conditional approval in the EU
por: Demirci, Ebru, et al.
Publicado: (2023)

Leveraging existing opportunities for improved Orphan Drug approval in the EU
por: Edfjäll, Catarina
Publicado: (2012)

Navigating Market Authorization: The Path Holoclar Took to Become the First Stem Cell Product Approved in the European Union
por: Pellegrini, Graziella, et al.
Publicado: (2017)

Fluctuations in Corneal Endothelial LAP2 Expression Levels Correlate with Passage Dependent Declines in Their Cell Proliferative Activity
por: Maurizi, Eleonora, et al.
Publicado: (2022)

Long-term clinical outcome and satisfaction survey in patients with neurotrophic keratopathy after treatment with cenegermin eye drops or amniotic membrane transplantation
por: Sacchetti, Marta, et al.
Publicado: (2021)

Nanoneedles Induce Targeted siRNA Silencing of p16 in the Human Corneal Endothelium
por: Maurizi, Eleonora, et al.
Publicado: (2022)

A fine-tuned β-catenin regulation during proliferation of corneal endothelial cells revealed using proteomics analysis
por: Maurizi, Eleonora, et al.
Publicado: (2020)

Dose‐Finding Studies Among Orphan Drugs Approved in the EU: A Retrospective Analysis
por: Schuller, Yvonne, et al.
Publicado: (2018)

The Effects of the Microbial Biostimulants Approved by EU Regulation 2019/1009 on Yield and Quality of Vegetable Crops
por: Fusco, Giovanna Marta, et al.
Publicado: (2022)

Chemical injury treated with autologous limbal epithelial stem cell transplantation and subconjunctival bevacizumab
por: Cavallini, Gian Maria, et al.
Publicado: (2014)

Limbal Stem Cell Transplantation: Clinical Results, Limits, and Perspectives
por: Sacchetti, Marta, et al.
Publicado: (2018)

Synthetic Routes to Approved Drugs Containing a Spirocycle †
por: Moshnenko, Nazar, et al.
Publicado: (2023)

EU-Approved Rapid Tests for Bovine Spongiform Encephalopathy Detect Atypical Forms: A Study for Their Sensitivities
por: Meloni, Daniela, et al.
Publicado: (2012)

Oncologic orphan drugs approved in the EU – do clinical trial data correspond with real-world effectiveness?
por: Schuller, Yvonne, et al.
Publicado: (2018)

New Halogen-Containing Drugs Approved by FDA in 2021: An Overview on Their Syntheses and Pharmaceutical Use
por: Benedetto Tiz, Davide, et al.
Publicado: (2022)

The “Topography” of Glaucomatous Defect Using OCT and Visual Field Examination
por: de Paula, Alessandro, et al.
Publicado: (2022)

Comparison of novel oncology drugs that received dual approval from the US accelerated approval and EU conditional marketing authorisation pathways, 2006–2021: a cross-sectional study
por: Xie, Jinping, et al.
Publicado: (2023)

The Challenging Melanoma Landscape: From Early Drug Discovery to Clinical Approval
por: Matias, Mariana, et al.
Publicado: (2021)

Discovery and Characterization of Synthesized and FDA-Approved Inhibitors of Clostridial and Bacillary Collagenases
por: Alhayek, Alaa, et al.
Publicado: (2022)

Role of Topical Cenegermin in Management of a Cornea Transplant in a Functionally Monocular Patient with Neurotrophic Keratitis and Facial Nerve Palsy: A Case Report
por: Pocobelli, Augusto, et al.
Publicado: (2020)

National gambling policies and the containment of the EU’s politico-legal influence
por: Selin, Jani
Publicado: (2019)

History of the discovery, development, and FDA-approval of buprenorphine medications for the treatment of opioid use disorder
por: Heidbreder, Christian, et al.
Publicado: (2023)

National Differences in Requirements for Ethical and Competent Authority Approval for a Multinational Vaccine Trial under the EU Directive 2001/20/EC
por: van Doorn, Eva, et al.
Publicado: (2015)

Comparison of pharmacokinetics, pharmacodynamics, safety, and immunogenicity of teriparatide biosimilar with EU- and US-approved teriparatide reference products in healthy men and postmenopausal women
por: Fenwick, Steven, et al.
Publicado: (2022)

Education for the translation of Advanced Therapy Medicinal Products
por: Adamo, Davide, et al.
Publicado: (2023)

Approvals in 2021: dangling Accelerated Approvals, drug dosing, new approvals and beyond
por: Lemery, Steven, et al.
Publicado: (2022)

Synthesis, Characterization, and Handling of Eu(II)-Containing Complexes for Molecular Imaging Applications
por: Basal, Lina A., et al.
Publicado: (2018)

The Latest FDA-Approved Pharmaceuticals Containing Fragments of Tailor-Made Amino Acids and Fluorine
por: Wang, Qian, et al.
Publicado: (2022)

Drug Discovery Prospect from Untapped Species: Indications from Approved Natural Product Drugs
por: Zhu, Feng, et al.
Publicado: (2012)

Repurposing FDA‐Approved Compounds for the Discovery of Glutaminyl Cyclase Inhibitors as Drugs Against Alzheimer's Disease
por: Xu, Chenshu, et al.
Publicado: (2020)

Access to trade credit and its impact on the use of European Union (EU) approved pesticides among smallholder cocoa farmers in Ondo State, Nigeria
por: Damilola Kehinde, Ayodeji
Publicado: (2022)

Eu(O(2)C‐C≡C‐CO(2)): An Eu(II) Containing Anhydrous Coordination Polymer with High Stability and Negative Thermal Expansion
por: Gramm, Verena K., et al.
Publicado: (2020)

Ionic Self-Assembled Luminescent Nanospheres from Cationic Polyelectrolyte and Eu-Containing Polyoxometalate
por: Qiu, Juan, et al.
Publicado: (2020)

Toward quantification of hypoxia using fluorinated Eu(II/III)-containing ratiometric probes
por: Subasinghe, S. A. Amali S., et al.
Publicado: (2023)

FDA-Approved Oximes and Their Significance in Medicinal Chemistry
por: Dhuguru, Jyothi, et al.
Publicado: (2022)

Regulatory Approved Monoclonal Antibodies Contain Framework Mutations Predicted From Human Antibody Repertoires
por: Petersen, Brian M., et al.
Publicado: (2021)

The emergence of diagnostic imaging technologies in breast cancer: discovery, regulatory approval, reimbursement, and adoption in clinical guidelines
por: Gold, Laura S., et al.
Publicado: (2012)

Cannot write session to /tmp/vufind_sessions/sess_rbdnmfiqb641elkr0rbspog019