Results 1 to 10 of about 1,644,719 (283)

Compliance in Non-Clinical Development of Cell-, Gene-, and Tissue-Based Medicines: Good Practice for Better Therapies

Stem Cells Translational Medicine, 2022
Abstract The development of cell-, gene- and tissue engineering (CGT)-based therapies must adhere to strict pharmaceutical quality management standards, as for any other biological or small-molecule drug. However, early developments often failed to fully comply with good laboratory practices (GLP) in non-clinical safety studies.
Luis Lopez-Navas, Sílvia Torrents, Rosario Sánchez-Pernaute, Joaquim Vives   +3 more
openaire   +5 more sources

Intraoperative Strategies for Minimal Manipulation of Autologous Adipose Tissue for Cell- and Tissue-Based Therapies: Concise Review [PDF]

Stem Cells Translational Medicine, 2019
AbstractThe stromal vascular fraction (SVF) is a heterogeneous population of stem/stromal cells isolated from perivascular and extracellular matrix (ECM) of adipose tissue complex (ATC). Administration of SVF holds a strong therapeutic potential for regenerative and wound healing medicine applications aimed at functional restoration of tissues damaged ...
Angelo Trivisonno, Robert W. Alexander, Silvia Baldari, Steven R. Cohen, Giuliana Di Rocco, Pietro Gentile, Guy Magalon, Jérémy Magalon, Randy B. Miller, Hayley Womack, Gabriele Toietta   +10 more
openaire   +3 more sources

Concise Review: Mind the Gap: Challenges in Characterizing and Quantifying Cell- and Tissue-Based Therapies for Clinical Translation [PDF]

Stem Cells, 2010
Abstract There are many challenges associated with characterizing and quantifying cells for use in cell- and tissue-based therapies. From a regulatory perspective, these advanced treatments must not only be safe and effective but also be made by high-quality manufacturing processes that allow for on-time delivery of viable products ...
Rayment, Erin A., Williams, David J.
openaire   +3 more sources

Regulatory insights on gene therapies, adeno-associated virus-based gene therapies, cell/tissue-based products, and medical care/practice in cell and gene therapies: Report from the 7th Asia partnership conference - April 25, 2024

Regenerative Therapy
The 7th Asia Partnership Conference of Regenerative Medicine (APACRM) was held both in person and online on April 25, 2024, to promote the regulatory harmonization of regenerative medicine products across Asia. Recognizing domestic regulatory guidelines and their underlying rationales within each country and region is an important initial step toward ...
Yoshie Tsurumaki, Yusuke Kagawa, Shigeaki Hayashi, Hirokuni Mizoguchi, Masaaki Miyano, Masaki Fujii, Ruriko Shinozaki, Srinivasan N. Kellathur, Alex J. Zhang, Kunihiko Suzuki, Masayuki Nomura   +10 more
openaire   +3 more sources

FDA Cell therapies and tissue-based products: a public workshop on generating scientific evidence to facilitate development (from Catapult's regulatory round-up for December 2024)

The FDA’s CBER OTP is hosting a virtual scientific public workshop on 25th February 2025, titled “Cell Therapies and Tissue-based Products: A Public Workshop on Generating Scientific Evidence to Facilitate Development.” The purpose of the workshop is to identify and discuss the current state of the science, development, and regulation for cellular ...
openaire   +2 more sources

Regenesis: Repair and regeneration reinvented in stem cell therapeutics. [PDF]

Stem Cell Reports
Chopra H, Han Y.
europepmc   +1 more source

A numerical study on the effect of laser therapy against port-wine stain by administering artificial red blood cells. [PDF]

Lasers Med Sci
Yoneoka S, Ogo T, Rikihisa N, Hyakutake T.   +3 more
europepmc   +1 more source

Cell and Gene Therapy in Equine Ocular Disease. [PDF]

Vet Ophthalmol
Young KAS, Schnabel LV, Gilger BC.
europepmc   +1 more source

FDA Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Small Entity Compliance Guide (Cell and Gene Therapy Catapult - Regulatory Round-up – November 2022)

, 2023
openaire   +2 more sources

Genome agnostic, multi-level non-oncogene addiction-based systems pharmacology for rescuing metastatic relapsed/refractory neoplasias. [PDF]

Front Pharmacol
Harrer DC, Lüke F, Pukrop T, Ghibelli L, Reichle A, Heudobler D.   +5 more
europepmc   +1 more source