Literature DB >> 25093890

An FDA perspective on preclinical development of cell-based regenerative medicine products.

Alexander M Bailey1, Michael Mendicino2, Patrick Au1.   

Abstract

Mesh：

Year:  2014        PMID： 25093890     DOI： 10.1038/nbt.2971

Source DB:  PubMed          Journal:  Nat Biotechnol        ISSN： 1087-0156            Impact factor:   54.908


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  2 in total

Review 1.  Balancing tissue and tumor formation in regenerative medicine.

Authors:  Alexander M Bailey
Journal:  Sci Transl Med       Date:  2012-08-15       Impact factor: 17.956

2.  MSC-based product characterization for clinical trials: an FDA perspective.

Authors:  Michael Mendicino; Alexander M Bailey; Keith Wonnacott; Raj K Puri; Steven R Bauer
Journal:  Cell Stem Cell       Date:  2014-02-06       Impact factor: 24.633
  2 in total
  23 in total

Review 1.  Regenerative medicine: Current therapies and future directions.

Authors:  Angelo S Mao; David J Mooney
Journal:  Proc Natl Acad Sci U S A       Date:  2015-11-24       Impact factor: 11.205

2.  The Role of Nonhuman Primate Animal Models in the Clinical Development of Pluripotent Stem Cell Therapies.

Authors:  So Gun Hong; Yongshun Lin; Cynthia E Dunbar; Jizhong Zou
Journal:  Mol Ther       Date:  2016-08       Impact factor: 11.454

Review 3.  Vascular diseases await translation of blood vessels engineered from stem cells.

Authors:  Rekha Samuel; Dan G Duda; Dai Fukumura; Rakesh K Jain
Journal:  Sci Transl Med       Date:  2015-10-14       Impact factor: 17.956

4.  Amelioration of Penetrating Ballistic-Like Brain Injury Induced Cognitive Deficits after Neuronal Differentiation of Transplanted Human Neural Stem Cells.

Authors:  Markus S Spurlock; Aminul I Ahmed; Karla N Rivera; Shoji Yokobori; Stephanie W Lee; Pingdewinde N Sam; Deborah A Shear; Michael P Hefferan; Thomas G Hazel; Karl K Johe; Shyam Gajavelli; Frank C Tortella; Ross M Bullock
Journal:  J Neurotrauma       Date:  2017-03-23       Impact factor: 5.269

5.  In vivo tracking of individual stem cells labeled with nanowire lasers using multimodality imaging.

Authors:  Xuzhou Li; Wei Zhang; Yanxiu Li; Xiaoqin Wu; Mingyang Wang; Xiaotian Tan; Yannis M Paulus; Xudong Fan; Xueding Wang
Journal:  Biomed Opt Express       Date:  2022-08-11       Impact factor: 3.562

Review 6.  Stem cell therapy for heart failure: Ensuring regenerative proficiency.

Authors:  Andre Terzic; Atta Behfar
Journal:  Trends Cardiovasc Med       Date:  2016-01-28       Impact factor: 6.677

7.  Inhibition of aberrant tissue remodelling by mesenchymal stromal cells singly coated with soft gels presenting defined chemomechanical cues.

Authors:  Chandramohan R Tamatam; Ik Sung Cho; Sing Wan Wong; Peter T Toth; Raymond Bargi; Patrick Belvitch; James C Lee; Jalees Rehman; Sekhar P Reddy; Jae-Won Shin
Journal:  Nat Biomed Eng       Date:  2021-06-03       Impact factor: 25.671

Review 8.  Tissue engineering and regenerative medicine: semantic considerations for an evolving paradigm.

Authors:  Ravi Katari; Andrea Peloso; Giuseppe Orlando
Journal:  Front Bioeng Biotechnol       Date:  2015-01-12

9.  Uncertainty and innovation: Understanding the role of cell-based manufacturing facilities in shaping regulatory and commercialization environments.

Authors:  Rosario Isasi; Vasiliki Rahimzadeh; Kathleen Charlebois
Journal:  Appl Transl Genom       Date:  2016-11-11

10.  Platelet-derived growth factor (PDGF)-AA/AB in human serum are potential indicators of the proliferative capacity of human synovial mesenchymal stem cells.

Authors:  Mitsuru Mizuno; Hisako Katano; Koji Otabe; Keiichiro Komori; Yukie Matsumoto; Shizuka Fujii; Nobutake Ozeki; Kunikazu Tsuji; Hideyuki Koga; Takeshi Muneta; Akifumi Matsuyama; Ichiro Sekiya
Journal:  Stem Cell Res Ther       Date:  2015-12-10       Impact factor: 6.832
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