Isct-cytotherapy.org

Tumorigenicity assessment of cell therapy products: …

WEBIn response to this emerging safety issue, the Health and Environmental Sciences Institute (HESI) launched a collaborative effort in late 2015 …

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URL: https://www.isct-cytotherapy.org/article/S1465-3249(19)30861-8/fulltext

U.S. FDA laws, regulations and guidance

WEBThe Public Health Services (PHS) Act contains specific laws for biologics, including Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), which can be found …

Category: Health Go Health

Advancing Autologous CAR T-cell Therapy through Real-Time …

WEBAutologous chimeric antigen receptor (CAR) T-cell therapy presents promising treatment outcomes for various cancers. However, its potential is restrained by unique supply …

Category: Cancer Go Health

Leukapheresis guidance and best practices for optimal

WEBTypically, the health care professional will assess the patient and decide if the leukapheresis procedure should be discontinued. A rapid response team may be …

Category: Health Go Health

Nonclinical and quality assessment of cell therapy products: …

WEBThe Health Sciences Authority (HSA) introduced a new law regulating cell, tissue and gene therapeutic products (CTGTP) under the Health Products Act, placing …

Category: Health Go Health

Prolonged Cytopenias after Immune Effector Cell Therapy and

WEBThe success of chimeric antigen receptor (CAR) T-cell therapy in treating B-cell malignancies, has led to the evaluation of CAR T-cells targeting a variety of other …

Category: Health Go Health

Outcomes with allogeneic stem cell transplant using cryopreserved

WEBAllogeneic hematopoietic stem cell transplant (alloHSCT) is a mainstay of treatment for hematologic malignancies such as acute leukemias and aggressive lymphomas. …

Category: Health Go Health

Safety of cell therapy products: in-vitro methods to assess the

WEBTo address this challenge, the Health and Environmental Sciences Institute (HESI) Cell Therapy-TRAcking, Circulation, & Safety (CT-TRACS) committee, convened …

Category: Health Go Health

Advancing Autologous CAR T-cell Therapy through Real-Time …

WEBThe patient health simulation employed the survival rate as the indicator for modeling patient health conditions. Each patient was initially assumed to have a starting survival …

Category: Health Go Health

Cell and gene therapy investment: evolution and future outlook on

WEBSpecialist health care investors tend to be scientifically savvy, with many having degrees in medicine or life sciences. It is unsurprising to us that both the 2018 …

Category: Medicine Go Health

Tumorigenicity assessment of cell therapy products: The need …

WEBHealth and Environmental Sciences Institute (HESI) launched a collaborative effort in late 2015 that ultimately established the HESI Cell Therapy— TRAcking, …

Category: Health Go Health

Options for imaging cellular therapeutics in vivo: a multi …

WEBAs more therapies are being developed and assessed, the Health and Environmental Sciences Institute (HESI) formed the Cell Ther-apy—Tracking, Circulation and Safety …

Category: Health Go Health

Assessment and comparison of viability assays for cellular products

WEBThe study included samples collected or manufactured at the Center for Cellular Engineering, National Institutes of Health Clinical Center (Bethesda, MD, USA) …

Category: Health Go Health

Current state of Health Canada regulation for cellular

WEBHealth Canada also engages in the Advanced Therapy Medicinal Product Cluster Meetings held between the US FDA, the EMA and the Asia-Pacific region. Stem …

Category: Health Go Health

Advances in automated cell washing and concentration

WEBThe successful commercialization of cell therapies requires thorough planning and consideration of product quality, cost and scale of the manufacturing …

Category: Health Go Health

Current state of Health Canada regulation for cellular and …

WEBregulations governing CGTP by Health Canada versus the FDA. Figure 2 illustrates the regulatory conduits for investigational and market approved CGTPs in Can-ada. …

Category: Health Go Health

The harmonization of World Health Organization International

WEBThe World Health Organization (WHO) assigns International Nonproprietary Names (INN) to pharmaceutical substances, including advanced therapy medicinal …

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Cell monitoring with optical coherence tomography

WEBCell sizes in the images were measured manually using ImageJ software (National Institutes of Health, Bethesda, MD, USA), and the mean cell sizes found in the …

Category: Health Go Health

Background and Application of the HE Pathway

WEBHospital exemption (HE) is a regulated pathway that allows the use of advanced therapy medicinal products (ATMPs) within the European Union (EU) under …

Category: Health Go Health

Decentralized manufacturing of cell and gene therapies

WEBDecentralized or “redistributed” manufacturing has the potential to revolutionize the manufacturing approach for cell and gene therapies (CGTs), moving …

Category: Health Go Health

CAR-T cell therapy in India requires a paradigm shift in training

WEBChimeric antigen receptor (CAR)-T cell therapy has revolutionized the treatment of some kinds of cancers. Hundreds of companies and academic institutions …

Category: Cancer Go Health

Comparison of new Brazilian legislation for the approval

WEBAdvanced therapy medicinal products (ATMPs) are a class of biological products for human use that are based on genes, cells and tissues. The first ATMP …

Category: Health Go Health

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