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Regulatory Oversight of Cell- and Tissue-Based Therapeutic Products and Gene Therapy Products in Singapore

2015
The regulatory environment for cell- and tissue-based therapeutic products and gene therapy products is rapidly evolving and drug regulatory agencies are working towards establishing a risk-based system in the regulatory framework. Similarly in Singapore, a risk-based tiered approach has been applied whereby clinical trials and product licence of high ...
Choon Wee, Goh   +3 more
openaire   +2 more sources

Regulatory Frameworks for Cell and Tissue Based Therapies in Europe and the USA

2010
Whereas some basic therapies based on tissues and cells have been in clinical use for years, regulatory regimes applying to such applications have recently been revised and extended in Europe and in the US. Moreover, advances in regenerative medicine present new challenges and new types of products for regulation.
Gudrun Tiedemann, Sebastian Sethe
openaire   +1 more source

Importance of repeat tissue biopsy and tissue-based epidermal growth factor receptor T790M testing in progressed nonsmall cell lung carcinoma patients upon negative plasma genotyping for selection of third-generation tyrosine kinase inhibitor therapy: A case study

Indian Journal of Cancer, 2017
Resistance to 1st or 2nd generation epidermal growth factor receptor (EGFR) - tyrosine kinases (TKIs) develops predominantly due to an acquired mutation, EGFR T790M. Third-generation EGFR-TKIs have demonstrated potent activity against TKI resistance mediated by EGFR T790M.
R, Mistry, A, Patil
openaire   +2 more sources

A Narrative Review on Efficacy of Cell‐ and Tissue‐Based Therapies for Diabetic Foot Ulcer

Advanced Therapeutics
AbstractDiabetic foot ulcers (DFUs) are complex, making conventional treatments challenging in restoring skin tissue. Stem cell therapy (SCT) and skin replacement therapy (SRT) offer promising solutions by addressing prolonged inflammation, impaired cell proliferation, and reduced extracellular support.
Behnaz Niroomand   +3 more
openaire   +1 more source

Tissue-based Gene Expression Diagnosis of Mild and Moderate T-cell-mediated Rejection to Guide Therapy in Kidney Transplants

Transplantation
Background. Mild histologic lesions of tubulo-interstitial inflammation could represent a “response-to-wounding” rather than allorecognition. Tissue gene expression may complement histopathology for T-cell-mediated rejection (TCMR) diagnostics. Methods.
Dhiren, Kumar   +12 more
openaire   +2 more sources

Cell- and tissue-based therapies for lung disease

2020
Jeffrey A. Whitsett   +3 more
openaire   +1 more source

Advanced therapies in wound management: cell and tissue based therapies, physical and bio-physical therapies smart and IT based technologies

Journal of Wound Care, 2018
Piaggesi, Alberto   +11 more
openaire   +5 more sources

Critical care management of chimeric antigen receptor T‐cell therapy recipients

Ca-A Cancer Journal for Clinicians, 2022
Alexander Shimabukuro-Vornhagen   +2 more
exaly  

Clinical insights into small cell lung cancer: Tumor heterogeneity, diagnosis, therapy, and future directions

Ca-A Cancer Journal for Clinicians, 2023
Ferenc Rényi-Vámos, Balázs Dome
exaly  

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