Donald Fink

Donald Fink
U.S. Food and Drug Administration | FDA

About

31
Publications
4,850
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1,031
Citations
Citations since 2016
0 Research Items
161 Citations
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2016201720182019202020212022051015202530
2016201720182019202020212022051015202530
2016201720182019202020212022051015202530

Publications

Publications (31)
Chapter
Full-text available
The US Food and Drug Administration (FDA) is responsible for the regulatory oversight of a wide range of products, including cellular and cell-based products or therapies regulated by the Office of Cellular, Tissue, and Gene Therapies (OCTGT) in the Center for Biologics Evaluation and Research (CBER). This chapter focuses on several key issues rele...
Chapter
Full-text available
The field of regenerative medicine encompasses a breathtaking array of interdisciplinary scientific approaches with the promise of delivering future therapies to meet current unmet medical needs for patients. Increasingly more of these innovative products are being translated into human clinical trials in the United States, and general familiarity...
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Regenerative medicine encompasses a breathtaking array of interdisciplinary scientific approaches which address a broad spectrum of clinical needs. Recent advances in scientific knowledge related to cell biology, gene transfer therapy, biomaterials, immunology, and engineering principles applicable to biological systems place this community in a po...
Chapter
The field of regenerative medicine encompasses a breathtaking array of interdisciplinary scientific approaches that address a broad spectrum of clinical needs. Recent advances in scientific knowledge related to cell biology, gene transfer therapy, biomaterials, immunology, and engineering principles applicable to biological systems place the regene...
Chapter
This chapter focuses on US Food and Drug Administration (FDA) regulatory considerations for stem/progenitor cell-based products (S/PCPs) intended to treat, mitigate or cure disease. Information critical to the regulatory decision-making process for determining the safety and effi cacy of investigational S/PCPs is described. Included are sections th...
Chapter
Stem cells are among the most complex biological therapeutic entities proposed for clinical use to date. In this chapter, a regulatory review approach used by the Food and Drug Administration (FDA) to assess the safety of novel stem cell–based products has been described. Primary responsibility for evaluating the safety of investigational new treat...
Article
Full-text available
Cell self-renewal and the capacity to differentiate into multiple cell types (pluripotency) are biological attributes casting stem cells as attractive candidates for development of therapies targeting indications that involve functional restoration of damaged tissues. In the United States, clinical trials designed to demonstrate the safety and effe...
Article
PC12 clones are established neuronal models to investigate mechanisms involved in the cross-talk between the neurotrophins and drugs. Chronic treatment of PC12 cells with the glucocorticoid agonist drug, dexamethasone (Dex), elicited a 50% decrease in the selective binding of 125 I-NGF along with a reduction in the NGF receptor p75 NTR mRNA and pro...
Chapter
As evidenced by the breadth and scope of information detailed in the chapters of this book that describe ongoing scientific advances in the arena of human stem cells, the isolation of these unique cell populations continues to fuel the expectation that an array of promising novel cellular therapeutics will be developed. It is anticipated that biolo...
Article
Full-text available
Tyrosine phosphorylation regulates cytokine-induced dimerization of STAT proteins. Serine phosphorylation has also been found to occur in a number of STAT proteins, including Stat1, Sat3, Stat4, Stat5a, Stat5b and Stat6, and was shown to be important for maximal transcriptional activation mediated by Stat1, Stat3 and Stat4, but not for Stat5a or St...
Article
: Nerve growth factor (NGF) increases arachidonic acid (AA) release by PC12 pheochromocytoma cells. To explore the role of protein kinase C (PKC) in this action of NGF, PKC was down-regulated by long-term treatment of the cells with phorbol 12-myristate 13-acetate (PMA). Such prolonged exposure to PMA (1 µM) resulted in the inhibition of NGF-induce...
Article
Full-text available
alpha-Synuclein (alpha-Syn) is implicated in the pathogenesis of Parkinson's Disease, genetically through missense mutations linked to early onset disease and pathologically through its presence in Lewy bodies. alpha-Syn is phosphorylated on serine residues; however, tyrosine phosphorylation of alpha-Syn has not been established (, ). A comparison...
Article
The capacity for the neurotrophic factor PACAP38 to regulate expression of nerve growth factor (NGF)-trkA receptors in PC12 cells has been examined. Treatment of PC12 cells with 5 nM PACAP38 for 48 h elicited a 2.5-fold increase in 125I-NGF binding sites. FACS and Western analysis of trkA receptor protein indicate an abundance of receptors. The PAC...
Article
The 38-amino-acid isoform of pituitary adenylate cyclase-activating polypeptide (PACAP38) elicits a robust outgrowth of neurites in cultured PC12 cells. Initiation of neurite outgrowth occurs within 4-8 hr after the addition of PACAP38. Treatment with PACAP38 does not elicit collateral activation of p140(trk) nerve growth factor receptor tyrosine k...
Article
Nerve growth factor (NGF) regulates proliferation, differentiation, and survival of sympathetic and sensory neurons through the tyrosine kinase activity of its receptor, p140trk. These biological effects of NGF depend upon the signal-mediating function of p140trk substrates which are likely to differ from cell to cell. To define p140trk receptor su...
Article
Full-text available
Nerve growth factor (NGF) treatment causes a profound down-regulation of epidermal growth factor receptors during the differentiation of PC12 cells. This process is characterized by a progressive decrease in epidermal growth factor (EGF) receptor level measured by 125I-EGF binding, tyrosine phosphorylation, and Western blotting. Treatment of the ce...
Article
IL-2-, IL-12-, and IFN-alpha-mediated signaling pathways were analyzed in primary NK cells and in the NK3.3 cell line. Gel mobility shift and immunoprecipitation analyses revealed that in addition to activating STAT3 (signal transducer and activator of transcription-3) and STAT5, IL-2 induced tyrosine and serine phosphorylation of STAT1 alpha, whic...
Article
Nerve growth factor (NGF) increases arachidonic acid (AA) release by PC12 pheochromocytoma cells. To explore the role of protein kinase C (PKC) in this action of NGF, PKC was down-regulated by long-term treatment of the cells with phorbol 12-myristate 13-acetate (PMA). Such prolonged exposure to PMA (1 microM) resulted in the inhibition of NGF-indu...
Article
Cells that lack the high affinity receptor component (trkA) for nerve growth factor (NGF) are unresponsive to NGF. We investigated whether C6-2B cells, a rat glioma derived cell line, express trkA and, as a consequence, are responsive to NGF. In these cells, NGF (100 ng/ml) failed to induce the mRNA encoding for c-fos protooncogene and the low affi...
Article
The relationship between 6-hydroxydopamine (6-OHDA)-induced ablation of central and peripheral adrenergic neurons and in situ C-1300 murine neuroblastoma (MNB) tumor growth and catecholamine concentration were investigated. Destruction of central and/or peripheral adrenergic neurons was produced by the intracerebral and/or s.c. administration of 6-...
Article
The in situ C-1300 murine neuroblastoma (MNB) tumor model was used to investigate the influence of exogenously administered nerve growth factor (NGF) on tumor growth and tissue catecholamine concentration in mice sympathectomized with 6-hydroxy-dopamine (6-OHDA) on postnatal days 4-10. Mice were implanted with 1 x 10(6) disaggregated MNB cells 3 da...
Article
Full-text available
PC12 cells contain at least three immunologically distinct phospholipase C (PLC) isozymes, PLC-beta, PLC-gamma, and PLC-delta. Treatment of PC12 cells with nerve growth factor (NGF) leads to an increase in the phosphorylation of PLC-gamma, but not of PLC-beta or PLC-delta. This increase can be seen in as little as 1 minute. The increased phosphoryl...
Article
The effect of nerve growth factor on the metabolism of arachidonic acid and the hydrolysis of phosphatidylinositol in PC12 cells was examined. Addition of nerve growth factor to PC12 cells isotopically labeled with [3H]arachidonic acid caused an increased release of radioactivity. In a similar manner, treatment of PC12 cells prelabeled with [3H]ino...
Article
The influence of host age and tumor load on survival time, tumor growth parameters and biochemical differentiation, as characterized by tumor catecholamine content, were investigated. A/J mice were implanted with tumor loads of 10(4), 10(5) and 10(6) disaggregated C-1300 murine neuroblastoma (MNB) cells at 1, 7, 14, 21 and 56 days of age. Studies p...
Article
Staphylococcal alpha-toxin at subcytotoxic concentrations stimulated phosphatidylinositol turnover and arachidonic acid release in undifferentiated cultures of pheochromocytoma PC12 cells. Stimulation of phospholipase A2 but not C was dependent on extracellular calcium. Addition of staphylococcal alpha-toxin to PC12 cells caused a dose-dependent, b...
Article
Full-text available
The in situ C-1300 murine neuroblastoma (MNB) tumor model was used to investigate the influence of 6-hydroxydopamine (6HD)-induced sympathectomy on tumor growth and catecholamine concentration. One week (adult) and 3 weeks (neonatal) after sympathectomy, mice were implanted with 10(6) disaggregated MNB cells. The time interval between implantation...
Article
Full-text available
The effect of purified beef heart cAMP-dependent protein kinase catalytic subunit on tyrosine aminotransferase activity in intact cultured rat H35 hepatoma cells was directly tested by micro-injection using human red blood cell ghosts as vehicles. Although the micro-injection procedure itself produced temporary fluctuations in protein synthesis and...

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