Results 1 to 10 of about 1,571 (148)

Validation of the FROM-16 in family members of patients receiving advanced therapy medicinal product (ATMP). [PDF]

Qual Life Res
Abstract Purpose: Outcome-based pricing models which consider domains of value not previously considered in healthcare, such as societal outcomes, are of increasing interest for healthcare systems. Societal outcomes can include family-reported outcome measures (FROMs), which measure the impact of disease upon the patient’s family members.
Brilliant CD, Finlay AY, Salek SM, Shah R, Bacon E, Laing H.   +5 more
europepmc   +8 more sources

Advanced therapy medicinal product (ATMP) classification – a case study on spinal cord injury [PDF]

Journal of Translational Medicine
Background The classification of Advanced Therapy Medicinal Products (ATMPs) within the European regulatory framework poses significant challenges, particularly when biomaterials are combined with viable cells, as in spinal cord injury (SCI) therapies ...
L. Duarte, M. Castellà, P. A. A. P. Marques, B. Gago   +3 more
doaj   +3 more sources

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

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   +5 more sources

Current State-Of-Play of the EU Advanced Therapy Medicinal Product (ATMP) Field, With an Emphasis on Belgian Human Cell and Tissue Products. [PDF]

Wound Repair Regen
ABSTRACT The late 1980s saw the emergence of experimental therapies based on human cell and tissue products (HCTPs) within academic and hospital settings, several of them wound healing related. In 2008, the European Commission introduced the Regulation on advanced therapy medicinal products (ATMPs), defining many of these HCTPs as ...
Verbeken G, Convents L, Delmotte N, Draye JP, Jennes S, Vanderkelen A, Nijs G, Lewalle P, Baudoux E, Cornu O, Vanlaere I, Pierlot A, Rose T, Pirnay JP.   +13 more
europepmc   +6 more sources

Bringing Advanced Therapy Medicinal Products (ATMPs) for Parkinson’s Disease to the Clinic: The Investigator’s Perspective [PDF]

Journal of Parkinson’s Disease, 2021
There is much excitement around the use of advanced therapy medicinal products (ATMPs), including cell and gene treatments, in Parkinson’s disease (PD). However, taking an ATMP to clinical trials in patients with PD is complex.
Roger A. Barker, Emma V. Cutting, Danielle M. Daft   +2 more
doaj   +4 more sources

Mini Cleanroom for the Manufacture of Advanced Therapy Medicinal Products (ATMP): Bioengineered Corneal Epithelium [PDF]

Pharmaceutics, 2021
Among several requirements for the manufacture of Advanced Therapy Medicinal Products (ATMP) are: following the guidelines of a pharmaceutical quality system, complying with Good Manufacturing Practice (GMP) and access to a cleanroom fulfilling strict environmental conditions (Class A work area and Class B environment).
Alvaro Meana, José F. Alfonso, Sergio Alonso Alonso   +2 more
exaly   +6 more sources

Transitioning From Preclinical Evidence to Advanced Therapy Medicinal Product: A Spanish Experience

Frontiers in Cardiovascular Medicine, 2021
A systematic and ordered product development program, in compliance with current quality and regulatory standards, increases the likelihood of yielding a successful advanced therapy medicinal product (ATMP) for clinical use as safe and effective therapy.
Paloma Gastelurrutia, Paloma Gastelurrutia, Paloma Gastelurrutia, Cristina Prat-Vidal, Cristina Prat-Vidal, Cristina Prat-Vidal, Joaquim Vives, Joaquim Vives, Joaquim Vives, Ruth Coll, Antoni Bayes-Genis, Antoni Bayes-Genis, Antoni Bayes-Genis, Antoni Bayes-Genis, Carolina Gálvez-Montón, Carolina Gálvez-Montón   +15 more
doaj   +3 more sources

Processing and Ex Vivo Expansion of Adipose Tissue-Derived Mesenchymal Stem/Stromal Cells for the Development of an Advanced Therapy Medicinal Product for use in Humans

Cells, 2021
Adipose tissue (AT) represents a commonly used source of mesenchymal stem/stromal cells (MSCs) whose proregenerative potential has been widely investigated in multiple clinical trials worldwide.
Anna Labedz-Maslowska, Agnieszka Szkaradek, Tomasz Mierzwinski, Zbigniew Madeja, Ewa Zuba-Surma   +4 more
doaj   +3 more sources

Challenges in Advanced Therapy Medicinal Product Development: A Survey among Companies in Europe

Molecular Therapy: Methods & Clinical Development, 2018
Advanced therapy medicinal products (ATMPs) hold promise as treatments for previously untreatable and high-burden diseases. Expectations are high and active company pipelines are observed, yet only 10 market authorizations were approved in Europe.
Renske M.T. ten Ham, Jarno Hoekman, Anke M. Hövels, Andre W. Broekmans, Hubert G.M. Leufkens, Olaf H. Klungel   +5 more
doaj   +3 more sources

Advanced therapy medicinal products (ATMPs) - An analysis of the global regulatory status. [PDF]

Br J Clin Pharmacol
Abstract Background A rapid progress in the development of advanced therapy medicinal products (ATMPs) has taken place over the past decades. The ATMPs hold great potential but face challenges in the clinical development and the regulatory process.
Cramer A, Sørup FKH, Lund M, Petersen TS, Karstoft K.   +4 more
europepmc   +2 more sources