Restricted accessResearch articleFirst published online 2020-03
Clear Evidence of Safety and Efficacy Is Needed for Stromal Vascular Fraction Products: Commentary on “Arguments for a Different Regulatory Categorization and Framework for Stromal Vascular Fraction”
RodriguezR, FrazierT, BunnellB, MoutonC, MarchK, KatzA, RubinJ, LlullR, SorensenJ and GimbleJ. (2019). Arguments for a different regulatory categorization and framework for stromal vascular fraction. Stem Cells Dev [Epub ahead of print]; DOI: 10.1089/scd.2019.0096.
2.
U.S. Food and Drug Administration. Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue Based Products: Minimal Manipulation and Homologous Use, December 2017. Accessible at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-considerations-human-cells-tissues-and-cellular-and-tissue-based-products-minimal. (Last accessed February6, 2020).
3.
Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products, 63 Fed. Reg. 26744 (to be codified at 21 CFR Parts 207, 807, and 1271).
4.
DominiciM, NicholsK, SrivastavaA, WeissDJ, EldridgeP, CuendeN, DeansRJ, RaskoJE, LevineAD, et al. (2015). 2013–2015 ISCT presidential task force on unproven cellular therapy. Positioning a scientific community on unproven cellular therapies: the 2015 International Society for Cellular Therapy Perspective. Cytotherapy, 17:1663–1666.
5.
SinghAK and McGuirkJP. (2016). Allogeneic stem cell transplantation: a historical and scientific overview. Cancer Res, 76:6445–6451.
6.
Young NS. (2018). Aplastic anemia. N Engl J Med, 379:1643–1656.
7.
LawL, HuntCL, van WijnenAJ, NassrA, LarsonAN, EldrigeJS, MauckWD, PingreeMJ, YangJ, et al. (2018). Office-based mesenchymal stem cell therapy for the treatment of musculoskeletal disease: a systematic review of recent human studies. Pain Med [Epub ahead of print]; DOI: 10.1093/pm/pny256.
8.
ZhengH, ZhangB, ChhatbarPY, DongY, AlawiehA, LoweF, HuX and FengW. (2018). Mesenchymal stem cell therapy in stroke: a systematic review of literature in pre-clinical and clinical research. Cell Transplant, 27:1723–1730.
9.
LaluMM, MazzarelloS, ZlepnigJ, DongYYR, MontroyJ, McIntyreL, DevereauxPJ, StewartDJ, David MazerC, et al. (2018). Safety and efficacy of adult stem cell therapy for acute myocardial infarction and ischemic heart failure (SafeCell Heart): a systematic review and meta-analysis. Stem Cells Transl Med, 7:857–866.
10.
ToyserkaniNM, JørgensenMG, TabatabaeifarS, JensenCH, SheikhSP and SørensenJA. (2017). Concise review: a safety assessment of adipose-derived cell therapy in clinical trials: a systematic review of reported adverse events. Stem Cells Transl Med, 6:1786–1794.
11.
KuriyanAE, AlbiniTA, TownsendJH, RodriguezM, PandyaHK, LeonardRE2nd, ParrottMB, RosenfeldPJ, Flynn JrHW and GoldbergJL. (2017). Vision loss after intravitreal injection of autologous “stem cells” for AMD. N Engl J Med, 376:1047–1053.
12.
GolderS, LokeYK, WrightK and NormanG. (2016). Reporting of adverse events in published and unpublished studies of health care interventions: a systematic review. PLoS Med, 13:e1002127.
13.
TurnerL and KnoepflerP. (2016). Selling stem cells in the USA: assessing the direct-to-consumer industry. Cell Stem Cell, 19:154–157.
14.
ShawD, de WertG, DondorpW, TownendD, BosG and van GelderM. (2017). Permitting patients to pay for participation in clinical trials: the advent of the P4 trial. Med Health Care Philos, 20:219–227.
15.
EmanuelEJ, JoffeS, GradyC, WendlerD and PersadG. (2015). Clinical research: should patients pay to play?. Sci Transl Med, 7:298ps16.
16.
U.S. Food and Drug Administrations. Framework for the Regulation of Regenerative Medicine Products. Accessible at: https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/framework-regulation-regenerative-medicine-products. (Last accessed February6, 2020).
17.
MarksP and GottliebS. (2018). Balancing safety and innovation for cell-based regenerative medicine. N Engl J Med, 378:954–959.