Page 17 - Mesenchymal Stem cells, Exosomes and vitamins in the fight aginst COVID
P. 17

Pain Physician: March/April 2020: 23:E71-E83





                   PressAnnouncements/ucm573427.htm.  www .fda.gov /ICECI /    97.  Liang B, Chen J, Li  T, et al. Clinical
               81.  Regulatory Considerations for Human   EnforcementActions/WarningLetters/  remission of a critically ill COVID-19
                   Cell,  Tissues, and Cellular and  Tissue-  ucm591225.htm.       patient treated by human umbilical cord
                   Based Products: Minimal Manipulation   89.  Associated Press. North Darkota stem   mesenchymal stem cells. ChinaXiv 2020;
                   and  Homologous  Use.  Guidance  cell clinic investigated after complaints.   202002.00084.
                   for Industry and Food and Drug   The Seattle Times, November 16, 2017.   98.  China uses stem cell therapy to treat
                   Administration Staff, November 2017.   Accessed date 3/18/2020.  severe  coronavirus  cases.  Gulf  News,
                   Accessed date 3/18/2020.        www.seattletimes.com/nation-    March 5, 2020. Accessed date: 3/15/2020.
                   www .fda.gov /downloads/        world/bismarck-stem-cell-clinic-  https://gulfnews.com/world/asia/china-
                   B i o l o g i c s B l o o d V a c c i n e s /  investigated-after-complaints/   uses-stem-cell-therapy-to-treat-severe-
                   GuidanceCompliance -         90.  Kuriyan  AE,  Albini TA, Townsend  JH,   coronavirus-cases-1.1583399782425
                   RegulatoryInformation/Guidances/  et al.  Vision loss after intravitreal   99.  ClinicalTrials.gov.   Mesenchymal
                   CellularandGeneTherapy/UCM585403.  injection  of  autologous  “stem  cells”   Stem Cell  Treatment for Pneumonia
                   pdf                             for AMD. N Engl J Med 2017; 376:1047-  Patients Infected  With 2019 Novel
               82.  U.S. Department of Health and Human   1053.                    Coronavirus. ClinicalTrials.gov Identifier:
                   Services. Same Surgical Procedure   91.  Malarkey MA. Warning letter to David   NCT04252118. Accessed date 3/15/2020.
                   Exception  under  21 CFR  1271.15(b):   G. Eller, Chief Executive Officer   https://clinicaltrials.gov/ct2/show/
                   Questions and  Answers Regarding the   and President, Celltex  Therapeutics   NCT04252118
                   Scope of the Exception. Guidance for   Corporation. Rockville, MD: Public   100.  ClinicalTrials.gov.  Umbilical  Cord
                   Industry. November 2017.        Health Service, Food and Drug   (UC)-Derived  Mesenchymal  Stem
                   www .fda.gov /downloads/        Administration; September 24, 2012.   Cells  (MSCs)  Treatment  for  the
                   BiologicsBlood-VaccinesdanceComplia  Accessed date 3/18/2020.   2019-novel  Coronavirus  (nCOV)
                   nceRegulatoryInformation/Guidances/  www .fda.gov /ICECI /      Pneumonia. ClinicalTrials.gov Identifier:
                   Tissue/UCM419926.pdf Accessed  date   E n f o r c e me nt A c t i o n s /  NCT04269525. Accessed date 3/15/2020.
                   3/18/2020.                      WarningLetters/2012/ucm323853.htm  https://clinicaltrials.gov/ct2/show/NCT0
               83.  U.S. Food and Drug  Administration.   92.  Schwarz  A. New procedure uses   4269525?term=stem+cells&cond=Coron
                   Regenerative  medicine  advanced  athletes’ own blood to treat injuries.   a+Virus+Infection&draw=2
                   therapy designation. March 13, 2017.   New York  Times,  2009, A1. Accessed   101.  ClinicalTrials.gov. Study of Human
                   Accessed date 3/18/2020.        date 3/18/2020.                 Umbilical Cord Mesenchymal Stem Cells
                   www.fda.gov/BiologicsBloodVaccines/  www.nytimes.com/2009/  02/17/  in the Treatment of Novel Coronavirus
                   CellularGeneTherapyProducts/    sports/17blood.html.            Severe Pneumonia. ClinicalTrials.gov
                   ucm537670.htm                93.  Piuzzi N, Ng M, Chughtai M, et al.   Identifier: NCT04273646. Accessed date
               84.  Murray IR, Chahla J, Frank RM, Piuzzi   The stem-cell market for the treatment   3/15/2020.
                   NS, Mandelbaum BR, Dragoo JL;   of  knee osteoarthritis:  A patient   https://clinicaltrials.gov/ct2/show/NCT0
                   Members  of  the Biologics  Association.   perspective.  J Knee Surg 2018; 31:551-  4273646?term=stem+cells&cond=Coron
                   Rogue stem cell clinics.  Bone Joint J   556.                   a+Virus+Infection&draw=2
                   2020; 102-B:148-154.         94.  Turner L, Knoepfler P. Selling stem   102.  ClinicalTrials.gov.   Therapy   for
               85.  Aicher RH. Is the FDA regulating the   cells in the USA: Assessing the direct-  Pneumonia Patients Infected by 2019
                   practice of medicine? Aesthet Surg J 2013;   to-consumer industry.  Cell Stem Cell   Novel Coronavirus. ClinicalTrials.gov
                   33:452-455.                     2016; 19:154-157.               Identifier: NCT04293692. Accessed date
               86.  Charo  A,  Sipp  D.  Rejuvenating  95.  Government of Canada. Health   3/15/2020.
                   regenerative medicine regulation.  N   Canada  Policy  Position  Paper  –   https://clinicaltrials.gov/ct2/show/NCT0
                   Engl J Med 2018; 378:504-505.   Autologous Cell  Therapy Products.   4293692?term=stem+cells&cond=Coron
               87.  Malarkey MA. Warning letter to Thomas   Accessed date 3/18/2020.  a+Virus+Infection&draw=2&rank=7
                   E.  Young, MD, Owner and Medical   www.canada.ca/en/health-canada/  103.  Alcayaga-Miranda  F,  Cuenca  J,
                   Director, Young Medical Spa. Rockville,   services/drugs-health-products/  Khoury M.  Antimicrobial  activity of
                   MD: Public Health Service, Food and   biologics-radiopharmaceuticals-  mesenchymal stem cells: Current status
                   Drug Administration; April  20,  2012.   genetic-therapies/applications-  and new perspectives of  antimicrobial
                   Accessed date 3/18/2020.        submissions/guidance-documents/  peptide-based therapies. Front Immunol
                   www .fda.gov /ICECI /           cell-therapy-policy.html        2017; 8:339.
                   E n f o r c e m e n t A c t i o n s /  96.  Chen  S. Coronavirus:  critically  ill   104.  Predictive Technology Group Addresses
                   WarningLetters/2012/ucm301620.htm  Chinese patient saved by stem cell   Use of Mesenchymal Stem Cells in
               88.  Warning Letter to John S.  Arnone,   therapy, study says.  South China   Treatment of Secondary Issues Related
                   American CryoStem Corporation from   Morning Post, March 2, 2020. Accessed   to Coronavirus. GlobeNewswire, March
                   Elizabeth Waltrip,  Acting  Program   date 3/18/2020.           17, 2020.
                   Division Director, Office of Biological   www.scmp.com/news/china/society/  https://finance.yahoo.com/news/
                   Products Operations – Division 1,   article/3053080/coronavirus-critically-  predictive-technology-group-addresses-
                   U.S. Food and Drug  Administration.   ill-chinese-patient-saved-stem-cell  mesenchymal-154552966.html
                   Accessed date 3/18/2020


                E82                                                                     www.painphysicianjournal.com
   12   13   14   15   16   17   18   19   20   21   22