Current state of U.S. Food and Drug Administration regulation for cellular and gene therapy products: potential cures on the horizon.

Cellular & Gene Therapies (CGTs) are complex products, which have been key foci of the International Society for Cell & Gene Therapy (ISCT). For this ISCT North American Legal & Regulatory Affairs Committee review publication, CGTs include but are not limited to somatic cell-based therapies, pluripotent cell-derived cell-based therapies, gene- or non-gene-modified or gene edited versions of these cell-based therapies, in vivo gene therapies, organ/tissue engineered products, and relevant combination products. These products are regulated by the Food and Drug Administration (FDA) in the United States.

Blood donation: comparing individual characteristics, attitudes, and feelings of donors and nondonors.

The shortage of blood donors and increased demand for blood is an important health issue. Finding ways to increase donor recruitment and retention is a priority and, thus, an important area for research. This article aims to better understand donors and nondonors on the basis of their social responsibility, susceptibility to interpersonal influence, involvement in and attitude towards the blood donation issue, and their aroused feelings.

Relative dose intensity--improving treatment and outcomes in early-stage breast cancer: a retrospective study.

Purpose/objectives: To determine the amount of chemotherapy delivered compared to amount of chemotherapy scheduled by calculating relative dose intensity (RDI) and to identify factors associated with nonadherence of scheduled treatment regimens for patients with early-stage breast cancer (ESBC).

Design: Retrospective, descriptive, correlational study.

Setting: Two community hospital cancer centers in northern Michigan.

Intra-operative preparation of autologous bone marrow-derived CD34-enriched cellular products for cardiac therapy.

Background And Aims: With the advent of regenerative therapy, there is renewed interest in the use of bone marrow as a source of adult stem and progenitor cells, including cell subsets prepared by immunomagnetic selection. Cell selection must be rapid, efficient and performed according to current good manufacturing practices. In this report we present a methodology for intra-operative preparation of CD34(+) selected autologous bone marrow for autologous use in patients receiving coronary artery bypass grafts or left ventricular assist devices.

Shipping of therapeutic somatic cell products.

Background Aims: Shipment of therapeutic somatic cells between a current good manufacturing practice (cGMP) facility and a clinic or between different cGMP facilities requires validated standard operating procedures (SOP). Under National Heart Lung & Blood Institute (NHLBI) sponsorship, the Production Assistance for Cellular Therapies (PACT) group conducted a validation study for the shipping SOP it has created, including shipments of cryopreserved somatic cells, fresh peripheral blood specimens and apheresis products.

Methods: Comparisons of pre- and post-shipped cells and cell products at the three participating facilities included measurements of viability, phenotypic profiles and cellular functions.

The power of the drug, nature of support, and their impact on homeless youth.

The purpose of this study was to explore homeless youths' perspectives on the power of drugs in their lives, the preferred type of drugs used, barriers to treatment, and strategies to prevent drug initiation and abuse. This was a descriptive, qualitative study using focus groups with a purposeful sample of 24 drug-using homeless youth. The results provided insight into the lives of drug-using homeless youth.

Effects of storage and leukoreduction on lymphocytes and Epstein-Barr virus genomes in platelet concentrates.

Background: Epstein-Barr virus (EBV) persists in infected B lymphocytes in blood donors. Lymphocytes are viable during platelet (PLT) storage. The effects of storage and leukoreduction on lymphocytes and EBV genomes are evaluated.

The extreme carboxyl terminus of v-Abl is required for lymphoid cell transformation by Abelson virus.

The v-Abl protein tyrosine kinase encoded by Abelson murine leukemia virus (Ab-MLV) induces transformation of pre-B cells in vivo and in vitro and can transform immortalized fibroblast cell lines in vitro. Although the kinase activity of the protein is required for these events, most previously studied mutants encoding truncated v-Abl proteins that lack the extreme carboxyl terminus retain high transforming capacity in NIH 3T3 cells but transform lymphocytes poorly. To understand the mechanisms responsible for poor lymphoid transformation, mutants expressing a v-Abl protein lacking portions of the COOH terminus were compared for their ability to transform pre-B cells.