Results 51 to 60 of about 7,116,245 (266)

Evolution of Mesenchymal Stem Cell Therapy as an Advanced Therapeutic Medicinal Product (ATMP)—An Indian Perspective

Bioengineering, 2022
Stem cells can be defined as the cells that have the capacity to both self-renew and give rise to differentiated cells. Under the right conditions and signals, depending on their origin and bio-plasticity, stem cells can differentiate into multiple cell ...
Sathish Muthu, Madhan Jeyaraman, Moinuddin Basha Kotner, Naveen Jeyaraman, Ramya Lakshmi Rajendran, Shilpa Sharma, Manish Khanna, Sree Naga Sowndary Rajendran, Ji Min Oh, Prakash Gangadaran, Byeong-Cheol Ahn   +10 more
doaj   +1 more source

Risk of discontinuation of Advanced Therapy Medicinal Products clinical trials [PDF]

Journal of Market Access & Health Policy, 2016
Advanced therapy medicinal products (ATMPs) constitute a class of innovative products that encompasses gene therapy, somatic cell therapy, and tissue-engineered products (TEP). There is an increased investment of commercial and non-commercial sponsors in this field and a growing number of ATMPs randomized clinical trials (RCT) and patients enrolled in ...
Hanna, Eve, Rémuzat, Cecile, Auquier, Pascal, Toumi, Mondher   +3 more
openaire   +2 more sources

Process data of allogeneic ex vivo-expanded ABCB5+ mesenchymal stromal cells for human use: off-the-shelf GMP-manufactured donor-independent ATMP

Stem Cell Research & Therapy, 2020
Background Human dermal mesenchymal stromal cells (MSCs) expressing the ATP-binding cassette (ABC) efflux transporter ABCB5 represent an easily accessible MSC population that, based on preclinical and first-in-human data, holds significant promise to ...
Seda Ballikaya, Samar Sadeghi, Elke Niebergall-Roth, Laura Nimtz, Jens Frindert, Alexandra Norrick, Nicole Stemler, Nicole Bauer, Yvonne Rosche, Vanessa Kratzenberg, Julia Pieper, Tina Ficek, Markus H. Frank, Christoph Ganss, Jasmina Esterlechner, Mark A. Kluth   +15 more
doaj   +1 more source

The regulation of advanced therapy medicinal products in europe and the role of academia [PDF]

Cytotherapy, 2013
Advanced therapy medicinal products (ATMP) are gene therapy, somatic cell therapy or tissue-engineered products regulated under (EC) No. 1394/2007 to ensure their free movement within the European Union while guaranteeing the highest level of health protection for patients.
Pearce KF, Hildebrandt M, Greinix H, Scheding S, Köhl U, Worel N, Apperley J, Edinger M, Hauser A, Mischak-Weissinger E, Dickinson AM, Lowdell MW   +11 more
openaire   +3 more sources

A systematic review of economic evaluations of advanced therapy medicinal products [PDF]

British Journal of Clinical Pharmacology, 2020
AimsAdvanced therapy medicinal products (ATMPs) represent a new category of medicinal products with a potential for transformative improvements in health outcomes but at exceptionally high prices. Routine adoption of ATMPs requires robust evidence of their cost‐effectiveness.MethodsA systematic literature review of economic evaluations of ATMPs ...
Huw Lloyd‐Williams, Dyfrig A. Hughes
openaire   +2 more sources

EU Regulatory Pathways for ATMPs: Standard, Accelerated and Adaptive Pathways to Marketing Authorisation

Molecular Therapy: Methods & Clinical Development, 2019
Advanced therapy medicinal products (ATMPs) require evaluation by the European Medicines Agency’s Committee for Advanced Therapies prior to being placed on the European market, subject to a Marketing Authorisation granted by the European Commission.
Giulia Detela, Anthony Lodge
doaj   +1 more source

Inactivated herpes simplex virus-1 vaccine formulated in aqueous and alcoholic extracts of propolis boosts cellular and IgG responses [PDF]

Iranian Journal of Basic Medical Sciences
Objective(s): In this study, the adjuvant activity of aqueous and alcoholic extracts of propolis was examined on the inactivated herpes simplex virus-1 (HSV-1).Materials and Methods: BALB/C mice were administered with inactivated (HSV-1; the KOS strain ...
Sanaz Mojarab, Pegah Karimi, Delavar Shahbazzadeh, Majid Moghbeli, Kamran Pooshang Bagheri, Arezoo Beig Parikhani, Rada Dehghan, Ehsan Zafari, Amir Moravej, Mohammad Hassan Pouriyayevali, Seyedeh Faranak Mirtalebi, Mahdi Pakjoo, Shaghayegh Yazdani, Meghdad Abdollahpour-alitappeh, Mehdi Mahdavi   +14 more
doaj   +1 more source

European Standard Clinical Practice Guideline and EXPeRT Recommendations for the Diagnosis and Management of Gastroenteropancreatic Neuroendocrine Neoplasms in Children and Adolescents

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Pediatric gastroenteropancreatic neuroendocrine neoplasms (GEP‐NENs) are extremely rare and clinically heterogeneous. Management has largely been extrapolated from adult practice. This European Standard Clinical Practice Guideline (ESCP), developed by the EXPeRT network in collaboration with adult NEN experts, provides (adult) evidence ...
Michaela Kuhlen, Calogero Virgone, Antje Redlich, Michael Abele, Ricardo Lopez‐Almaraz, Tal Ben‐Ami, Ewa Bien, Gianni Bisogno, Maja Mazic Cesen, Andrea Ferrari, Malgorzata A. Krawczyk, Yves Reguerre, Dominik T. Schneider, Ines B. Brecht, Charlotte Rigaud, Bilgehan Yalcin, Rainer Claus, Christian Vokuhl, Constantin Lapa, Jörg Fuchs, Segolene Hescot, Thomas Walter, Julien Hadoux, Daniel Orbach   +23 more
wiley   +1 more source

A promising combination strategy: oncolytic adenovirus (ΔE1B-55 K/E3) and arsenic trioxide for potent cancer therapy

Scientific Reports
Oncolytic adenovirus has emerged as a promising tool in cancer therapy due to its ability to infect and proliferate preferentially within tumor cells. However, due to its insufficient antitumor activity for effective tumor elimination, various approaches,
Maryam Kadkhodazadeh, Hamed Sabri, Mahdi Pakjoo, Sanam Sadeghi-Mohammadi, Farzaneh Barkhordari, Maryam Bagherian, Ramin Sarrami-Forooshani   +6 more
doaj   +1 more source

Infrastructural considerations of implementing gene therapy for hemophilia in the Nordic context

Therapeutic Advances in Hematology, 2023
Background: Despite improvements in hemophilia care, challenges remain, including treatment burden and impaired quality of life. Gene therapy may overcome these. However, its introduction presents a challenge. Objectives: To outline a function-based gene
Jan Astermark, Fariba Baghaei, Karin Strandberg, Petra Gabric Toplican, Maj Friberg Birkedal, Emma Engman Grahn, Charlotta Hansson, Peter Kampmann, Anna-Elina Lehtinen, Kinga Täckström, Pål Andre Holme, Maria Magnusson   +11 more
doaj   +1 more source