Literature DB >> 18830917

Clinical trials in gene therapy: ethics of informed consent and the future of experimental medicine.

Pedro R Lowenstein.   

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Year:  2008        PMID: 18830917      PMCID: PMC2659702     

Source DB:  PubMed          Journal:  Curr Opin Mol Ther        ISSN: 1464-8431


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  14 in total

1.  Human gene therapy, consent, and the realities of clinical research: is it time for a research subject advocate?

Authors:  Tomas Jose Silber
Journal:  Hum Gene Ther       Date:  2008-01       Impact factor: 5.695

2.  If it's broken, shouldn't it be fixed? Informed consent and initial clinical trials of gene therapy.

Authors:  Arthur L Caplan
Journal:  Hum Gene Ther       Date:  2008-01       Impact factor: 5.695

3.  Safety and tolerability of intraputaminal delivery of CERE-120 (adeno-associated virus serotype 2-neurturin) to patients with idiopathic Parkinson's disease: an open-label, phase I trial.

Authors:  William J Marks; Jill L Ostrem; Leonard Verhagen; Philip A Starr; Paul S Larson; Roy Ae Bakay; Robin Taylor; Deborah A Cahn-Weiner; A Jon Stoessl; C Warren Olanow; Raymond T Bartus
Journal:  Lancet Neurol       Date:  2008-04-02       Impact factor: 44.182

Review 4.  The ethics of human gene transfer.

Authors:  Jonathan Kimmelman
Journal:  Nat Rev Genet       Date:  2008-03       Impact factor: 53.242

5.  Protections for participants in gene therapy trials: a patient's perspective.

Authors:  Suzanne R Pattee
Journal:  Hum Gene Ther       Date:  2008-01       Impact factor: 5.695

6.  Safety and efficacy of gene transfer for Leber's congenital amaurosis.

Authors:  Albert M Maguire; Francesca Simonelli; Eric A Pierce; Edward N Pugh; Federico Mingozzi; Jeannette Bennicelli; Sandro Banfi; Kathleen A Marshall; Francesco Testa; Enrico M Surace; Settimio Rossi; Arkady Lyubarsky; Valder R Arruda; Barbara Konkle; Edwin Stone; Junwei Sun; Jonathan Jacobs; Lou Dell'Osso; Richard Hertle; Jian-xing Ma; T Michael Redmond; Xiaosong Zhu; Bernd Hauck; Olga Zelenaia; Kenneth S Shindler; Maureen G Maguire; J Fraser Wright; Nicholas J Volpe; Jennifer Wellman McDonnell; Alberto Auricchio; Katherine A High; Jean Bennett
Journal:  N Engl J Med       Date:  2008-04-27       Impact factor: 91.245

7.  Results from a phase I safety trial of hAADC gene therapy for Parkinson disease.

Authors:  J L Eberling; W J Jagust; C W Christine; P Starr; P Larson; K S Bankiewicz; M J Aminoff
Journal:  Neurology       Date:  2008-04-09       Impact factor: 9.910

8.  Safety and tolerability of gene therapy with an adeno-associated virus (AAV) borne GAD gene for Parkinson's disease: an open label, phase I trial.

Authors:  Michael G Kaplitt; Andrew Feigin; Chengke Tang; Helen L Fitzsimons; Paul Mattis; Patricia A Lawlor; Ross J Bland; Deborah Young; Kristin Strybing; David Eidelberg; Matthew J During
Journal:  Lancet       Date:  2007-06-23       Impact factor: 79.321

9.  Treatment of leber congenital amaurosis due to RPE65 mutations by ocular subretinal injection of adeno-associated virus gene vector: short-term results of a phase I trial.

Authors:  William W Hauswirth; Tomas S Aleman; Shalesh Kaushal; Artur V Cideciyan; Sharon B Schwartz; Lili Wang; Thomas J Conlon; Sanford L Boye; Terence R Flotte; Barry J Byrne; Samuel G Jacobson
Journal:  Hum Gene Ther       Date:  2008-10       Impact factor: 5.695

10.  Modulation of metabolic brain networks after subthalamic gene therapy for Parkinson's disease.

Authors:  Andrew Feigin; Michael G Kaplitt; Chengke Tang; Tanya Lin; Paul Mattis; Vijay Dhawan; Matthew J During; David Eidelberg
Journal:  Proc Natl Acad Sci U S A       Date:  2007-11-27       Impact factor: 11.205

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  9 in total

1.  Risk in clinical research: size matters!

Authors:  Pedro R Lowenstein
Journal:  Mol Ther       Date:  2009-11       Impact factor: 11.454

Review 2.  Accepting risk in clinical research: is the gene therapy field becoming too risk-averse?

Authors:  Claire T Deakin; Ian E Alexander; Ian Kerridge
Journal:  Mol Ther       Date:  2009-09-22       Impact factor: 11.454

Review 3.  Uncertainty in the translation of preclinical experiments to clinical trials. Why do most phase III clinical trials fail?

Authors:  Pedro R Lowenstein; Maria G Castro
Journal:  Curr Gene Ther       Date:  2009-10       Impact factor: 4.391

4.  Challenges in the evaluation, consent, ethics and history of early clinical trials - Implications of the Tuskegee 'trial' for safer and more ethical clinical trials.

Authors:  Pedro R Lowenstein; Elijah D Lowenstein; Maria G Castro
Journal:  Curr Opin Mol Ther       Date:  2009-10

5.  Recent Findings Concerning PAMAM Dendrimer Conjugates with Cyclodextrins as Carriers of DNA and RNA.

Authors:  Hidetoshi Arima; Keiichi Motoyama
Journal:  Sensors (Basel)       Date:  2009-08-17       Impact factor: 3.576

Review 6.  DREADDs in Epilepsy Research: Network-Based Review.

Authors:  John-Sebastian Mueller; Fabio Cesar Tescarollo; Hai Sun
Journal:  Front Mol Neurosci       Date:  2022-04-07       Impact factor: 6.261

7.  A novel peptide (GX1) homing to gastric cancer vasculature inhibits angiogenesis and cooperates with TNF alpha in anti-tumor therapy.

Authors:  Bei Chen; Shanshan Cao; Yingqi Zhang; Xin Wang; Jie Liu; Xiaoli Hui; Yi Wan; Wenqi Du; Li Wang; Kaichun Wu; Daiming Fan
Journal:  BMC Cell Biol       Date:  2009-09-09       Impact factor: 4.241

8.  Polyamidoamine Dendrimer Conjugates with Cyclodextrins as Novel Carriers for DNA, shRNA and siRNA.

Authors:  Hidetoshi Arima; Keiichi Motoyama; Taishi Higashi
Journal:  Pharmaceutics       Date:  2012-02-01       Impact factor: 6.321

Review 9.  Neurogenethics: An emerging discipline at the intersection of ethics, neuroscience, and genomics.

Authors:  Turhan Canli
Journal:  Appl Transl Genom       Date:  2015-05-15
  9 in total

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