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Therapy: Gene Therapy
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Total 5568 results found since Jan 2013.
Random Integration Analysis of Recombinant Adeno-Associated Virus 6 Packaged in Sf9 Insect Cells
In this study, we used different doses of Baculo-Sf9 produced rAAV6-EGFP to transduce HEK293T cells and A549-implanted tumors in vitro and in vivo. Using flow cytometry and fluorescence microscopy, we studied their EGFP gene expression efficiencies and EGFP fluorescence intensities. Using inverse nested PCR and DNA sequencing, random integration sites of rAAV6-EGFP genome into human chromosomes were identified. In vitro results showed that gene expression efficiencies became stable after 20 days and random integration frequencies were 0.2-4.2%. Both in vitro and in vivo results indicated that random integration of Baculo-S...
Source: Molekuliarnaia Biologiia - August 2, 2023 Category: Molecular Biology Authors: M H Zhang X M Liu C Zhang Source Type: research
Canadian Regulatory Framework and Regulatory Requirements for Cell and Gene Therapy Products
Adv Exp Med Biol. 2023;1430:91-116. doi: 10.1007/978-3-031-34567-8_6.ABSTRACTHealth Canada regulates gene therapy products and many cell therapy products as biological drugs under the Canadian Food and Drugs Act and its attendant regulations. Cellular products that meet certain criteria, including minimal manipulation and homologous use, may be subjected to a standards-based approach under the Safety of Human Cells, Tissues and Organs for Transplantation Regulations. The manufacture and clinical testing of cell and gene therapy products (CGTP) presents many challenges beyond those for protein biologics. Cells cannot be sub...
Source: Adv Data - August 1, 2023 Category: Epidemiology Authors: Jian Wang Emily Griffiths Omar Tounekti Martin Nemec Eric Deneault Jessie R Lavoie Anthony Ridgway Source Type: research
United States Food and Drug Administration Regulation of Human Cells, Tissues, and Gene Therapies
Adv Exp Med Biol. 2023;1430:71-89. doi: 10.1007/978-3-031-34567-8_5.ABSTRACTResearch and development of gene therapies and cell- or tissue-based therapies has experienced exponential growth in recent decades and the potential for these products to treat diverse, often rare, clinical indications is promising. The Office of Therapeutic Products (OTP) in the Center for Biologics Evaluation and Research (CBER) at the United States Food and Drug Administration (US FDA) is responsible for the regulation of these products, among others, throughout the entire product lifecycle. This chapter provides an overview of the science- and...
Source: Adv Data - August 1, 2023 Category: Epidemiology Authors: Sandhya Sanduja Liz Lessey-Morillon Rondine Allen Xiaofei Wang Gavin Imperato Judith Arcidiacono Source Type: research
Clinical Trials on Advanced Therapy Investigational Medicinal Products in Spain (2004-2022): Experience and Challenges for the Future
Adv Exp Med Biol. 2023;1430:23-39. doi: 10.1007/978-3-031-34567-8_2.ABSTRACTClinical investigation is the basis for establishing how useful advanced therapy investigational medicinal products (ATiMP) are for the treatment of serious diseases.In Spain, clinical trials (CT) on ATiMP need to follow the general European legislation on CT with medicinal products plus some specific legislation and guidance depending on the type of ATiMP.This chapter describes the characteristics of CT on ATiMP authorized in Spain in the period 2004-2022 and the legislation applicable along this period. There are clear differences in the clinical...
Source: Adv Data - August 1, 2023 Category: Epidemiology Authors: Juan Est évez Álamo Marcos Tim ón Isabel S ánchez Afán de Rivera Beatriz Iriarte Torres M Antonia Serrano Castro Source Type: research
Marketing Regulatory Oversight of Advanced Therapy Medicinal Products in Europe
Adv Exp Med Biol. 2023;1430:1-21. doi: 10.1007/978-3-031-34567-8_1.ABSTRACTAdvanced therapy medicinal products (ATMP) in the European Union (EU) are regulated by Regulation 1394/2007 and comprise gene and cell therapy and tissue-engineered products. Under this framework, ATMP are authorised by the centralised procedure, coordinated by the European Medicines Agency (EMA), whereas clinical trial authorisations remain at the remit of each National Competent Authority. The Committee for Advanced Therapies is responsible for the scientific evaluation of the marketing authorisation applications and for generating a draft opinion...
Source: Adv Data - August 1, 2023 Category: Epidemiology Authors: Martina Schuessler-Lenz Carla Herberts Ilona Reischl Sol Ruiz Patrick Celis Claire Beuneu Rune Kjeken Marcos Tim ón Source Type: research
European Pharmacopoeia's Approach to Cell and Gene Therapy: Focus on How Gene Therapy Texts Are Evolving
Adv Exp Med Biol. 2023;1430:59-70. doi: 10.1007/978-3-031-34567-8_4.ABSTRACTThe European Pharmacopoeia (Ph. Eur.) constitutes single recognised common standard for the quality control of medicines in Europe, which is also applied in many countries worldwide. In 2000, the European Pharmacopoeia Commission (EPC), the decision-making body of the Ph. Eur., set out to elaborate a text on gene therapy products. This resulted in the publication of the widely used and much appreciated general chapter Gene transfer medicinal products for human use (5.14) in 2006, at a time when no gene therapy medicinal products were yet approved o...
Source: Herpes - August 1, 2023 Category: Infectious Diseases Authors: Olga Kolaj-Robin Marie-Th érèse Duffour Source Type: research
Development of Oral Bio-banks Past, Present and Future; Challenges and Opportunities
Curr Gene Ther. 2023 Aug 1. doi: 10.2174/1566523223666230801090355. Online ahead of print.ABSTRACTBiobank involves collecting, processing, storing, and organizing biosamples, along with relevant personal and health information such as medical history, family records, genetics data, and lifestyle details, for medical research and clinical care. Oral biobanking is a recently evolved field alongside the rising of precision medicine due to recent research findings in oral oncology and other oral complaints, namely caries and periodontal disease. The common samples in oral biobanks are matured and primary teeth, dental pulp cel...
Source: Current Gene Therapy - August 1, 2023 Category: Genetics & Stem Cells Authors: Baniekal Hiremath Gangadhar Kondragunta Omkarbabu Madhavi Hemant Kokate Baskar Venkidasamy Murugesan Krishnan Arun Murugaiyan Source Type: research
Isoliquiritin Ameliorates Ulcerative Colitis in Rats through Caspase 3/HMGB1/TLR4 Dependent Signaling Pathway
CONCLUSION: Isoliquiritin could reduce intestinal inflammation and mucosal damage of TNBS-induced colitis in rats with a certain anti-UC effect. Meanwhile, isoliquiritin treatment also inhibited the expression of HMGB1, TLR4, and MyD88 in LPS-induced Caco-2 cells. These results indicated that isoliquiritin could ameliorate UC through the caspase-3/HMGB1/TLR4-dependent signaling pathway.PMID:37526181 | DOI:10.2174/1566523223666230731115236
Source: Current Gene Therapy - August 1, 2023 Category: Genetics & Stem Cells Authors: Zhiwei Miao Mingjia Gu Faisal Raza Hajra Zafar Jianyi Huang Yuhang Yang Muhammad Sulaiman Jing Yan Yi Xu Source Type: research
