Literature DB >> 24506881

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

Michael Mendicino1, Alexander M Bailey2, Keith Wonnacott3, Raj K Puri3, Steven R Bauer4.   

Abstract

Proposals submitted to the FDA for MSC-based products are undergoing a rapid expansion that is characterized by increased variability in donor and tissue sources, manufacturing processes, proposed functional mechanisms, and characterization methods. Here we discuss the diversity in MSC-based clinical trial product proposals and highlight potential challenges for clinical translation.
Copyright © 2014 Elsevier Inc. All rights reserved.

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Year:  2014        PMID: 24506881     DOI: 10.1016/j.stem.2014.01.013

Source DB:  PubMed          Journal:  Cell Stem Cell        ISSN: 1875-9777            Impact factor:   24.633


  163 in total

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2.  Enabling mesenchymal stromal cell immunomodulatory analysis using scalable platforms.

Authors:  Evelyn Kendall Williams; José R García; Robert G Mannino; Rebecca S Schneider; Wilbur A Lam; Andrés J García
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Review 3.  Mesenchymal Stromal Cells: Clinical Challenges and Therapeutic Opportunities.

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Journal:  Cell Stem Cell       Date:  2018-06-01       Impact factor: 24.633

4.  Proteomic Profiling of Native Unpassaged and Culture-Expanded Mesenchymal Stromal Cells (MSC).

Authors:  Erika Moravcikova; E Michael Meyer; Mirko Corselli; Vera S Donnenberg; Albert D Donnenberg
Journal:  Cytometry A       Date:  2018-09-13       Impact factor: 4.355

Review 5.  Engineered Mesenchymal Stem Cells for Targeting Solid Tumors: Therapeutic Potential beyond Regenerative Therapy.

Authors:  Shen Cheng; Susheel Kumar Nethi; Sneha Rathi; Buddhadev Layek; Swayam Prabha
Journal:  J Pharmacol Exp Ther       Date:  2019-06-07       Impact factor: 4.030

6.  Variation in primary and culture-expanded cells derived from connective tissue progenitors in human bone marrow space, bone trabecular surface and adipose tissue.

Authors:  Maha A Qadan; Nicolas S Piuzzi; Cynthia Boehm; Wesley Bova; Malcolm Moos; Ronald J Midura; Vincent C Hascall; Christopher Malcuit; George F Muschler
Journal:  Cytotherapy       Date:  2018-02-01       Impact factor: 5.414

7.  Engineered Ovarian Cancer Cell Lines for Validation of CAR T Cell Function.

Authors:  Claire E Repellin; Priya Ganesan; Javier F Alcudia; Haritha K Duggireddy Lakshmireddy; Puja Patel; Lucia Beviglia; Harold S Javitz; Lidia Sambucetti; Parijat Bhatnagar
Journal:  Adv Biosyst       Date:  2019-11-29

Review 8.  Mesenchymal Stromal Cell Therapies for Neurodegenerative Diseases.

Authors:  Nathan P Staff; David T Jones; Wolfgang Singer
Journal:  Mayo Clin Proc       Date:  2019-05       Impact factor: 7.616

9.  Combinatorial cassettes to systematically evaluate tissue-engineered constructs in recipient mice.

Authors:  Subhadip Bodhak; Luis F de Castro; Sergei A Kuznetsov; Maeda Azusa; Danielle Bonfim; Pamela G Robey; Carl G Simon
Journal:  Biomaterials       Date:  2018-09-24       Impact factor: 12.479

10.  A randomized, controlled study to evaluate the efficacy of intra-articular, autologous adipose tissue injections for the treatment of mild-to-moderate knee osteoarthritis compared to hyaluronic acid: a study protocol.

Authors:  Ian A Jones; Melissa Wilson; Ryan Togashi; Bo Han; Austin K Mircheff; C Thomas Vangsness
Journal:  BMC Musculoskelet Disord       Date:  2018-10-24       Impact factor: 2.362

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