Literature DB >> 25945404

US stem cell clinics, patient safety, and the FDA.

Leigh Turner1.   

Abstract

Scholarship on patients accessing unproven stem cell interventions is dominated by research addressing 'stem cell tourism' to such countries as China, India, Mexico, and the Ukraine. However, clinics marketing 'adipose-derived mesenchymal stem cell treatments' are proliferating across the USA. These businesses typically claim to operate in compliance with federal regulations, but careful review of their commercial practices suggests that such clinics are marketing unapproved and noncompliant biological drugs.
Copyright © 2015 Elsevier Ltd. All rights reserved.

Entities:  

Keywords:  FDA; United States; federal regulations; marketing; stem cell clinics

Mesh:

Year:  2015        PMID: 25945404     DOI: 10.1016/j.molmed.2015.02.008

Source DB:  PubMed          Journal:  Trends Mol Med        ISSN: 1471-4914            Impact factor:   11.951


  18 in total

1.  CORR® International - Asia-Pacific: Stem Cell-based Treatments in Orthopaedic Clinical Practice-Is it Ready For Primetime in the Asia-Pacific Region?

Authors:  Tae Kyun Kim
Journal:  Clin Orthop Relat Res       Date:  2019-04       Impact factor: 4.176

Review 2.  Ethical and Regulatory Challenges with Autologous Adult Stem Cells: A Comparative Review of International Regulations.

Authors:  Tamra Lysaght; Ian H Kerridge; Douglas Sipp; Gerard Porter; Benjamin J Capps
Journal:  J Bioeth Inq       Date:  2017-02-28       Impact factor: 1.352

Review 3.  The Economics and Regulation of PRP in the Evolving Field of Orthopedic Biologics.

Authors:  Ian A Jones; Ryan C Togashi; C Thomas Vangsness
Journal:  Curr Rev Musculoskelet Med       Date:  2018-12

Review 4.  Concise Review: A Comprehensive Analysis of Reported Adverse Events in Patients Receiving Unproven Stem Cell-Based Interventions.

Authors:  Gerhard Bauer; Magdi Elsallab; Mohamed Abou-El-Enein
Journal:  Stem Cells Transl Med       Date:  2018-07-31       Impact factor: 6.940

5.  Vision Loss after Intravitreal Injection of Autologous "Stem Cells" for AMD.

Authors:  Ajay E Kuriyan; Thomas A Albini; Justin H Townsend; Marianeli Rodriguez; Hemang K Pandya; Robert E Leonard; M Brandon Parrott; Philip J Rosenfeld; Harry W Flynn; Jeffrey L Goldberg
Journal:  N Engl J Med       Date:  2017-03-16       Impact factor: 91.245

Review 6.  Stem cell/cellular interventions in human spinal cord injury: Is it time to move from guidelines to regulations and legislations? Literature review and Spinal Cord Society position statement.

Authors:  Harvinder S Chhabra; Kanchan Sarda; Geeta Jotwani; M Gourie-Devi; Erkan Kaptanoglu; Susan Charlifue; S L Yadav; B Mohapatra; Abhishek Srivastava; Kedar Phadke
Journal:  Eur Spine J       Date:  2019-05-16       Impact factor: 3.134

7.  Regulated and Unregulated Clinical Trials of Stem Cell Therapies for Stroke.

Authors:  Michael G Liska; Marci G Crowley; Cesar V Borlongan
Journal:  Transl Stroke Res       Date:  2017-01-26       Impact factor: 6.829

8.  Evaluation of Patient Preference and Perception Regarding the Clinical Use of Autologous Versus Allogeneic Cell Therapy in Orthopedic Surgery.

Authors:  Claire D Eliasberg; Daniel A Nemirov; Samuel J E Green; Stephen G Melancon; Scott A Rodeo
Journal:  HSS J       Date:  2021-05-22

9.  Role of Nursing Competencies for Accelerating Clinical Trials in Stem Cell Clinics.

Authors:  Mary Perrin; Teresa Kim; Rodica Stan; Pamela Giesie; Jason Tabor; Virginia Le Verche; Shirley Johnson; Geoffrey P Lomax; John A Zaia
Journal:  Stem Cells Transl Med       Date:  2017-11-03       Impact factor: 6.940

Review 10.  Can civil lawsuits stem the tide of direct-to-consumer marketing of unproven stem cell interventions.

Authors:  Claire Horner; Evelyn Tenenbaum; Douglas Sipp; Zubin Master
Journal:  NPJ Regen Med       Date:  2018-02-19
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