Commentary
Volume 16 Issue 11 - 2020
The Path to FDA Approval of MSC Therapy Will be Accelerated by COVID-19
Grumet Martin1,2,3, Bernstein Daniel1 and Loike John4*
1Department of Cell Biology and Neuroscience, Rutgers University, New Jersey, United States
2WM Center for Collaborative Neuroscience, New Jersey, United States
3Rutgers Stem Cell Research Center, New Jersey, United States
4Touro College and University System, New York, United States
*Corresponding Author: John Loike, Touro College and University System, New York, United States.
Received: July 10, 2020; Published: October 09, 2020




Keywords: COVID-19; Mesenchymal Stem Cells; Cytokine Storm; Clinical Trials

Efficacy of mesenchymal stem cells (MSC) has been demonstrated in thousands of pre-clinical studies for a wide range of diseases and injuries that elicit an overpowering inflammatory response. The capacity of MSC to dramatically reduce inflammation forms a solid foundation to justify the ~1,000 clinical trials using MSC that have been registered at ClinicalTrials.gov [1]. Despite this large number of trials, over the past 17 years, clinical use of MSC has not yet been approved by the FDA. The urgent need to treat life-threating stages of COVID-19 may prove to be a turning point for FDA approval of MSC in various inflammatory disorders.

References

  1. Kabat M., et al. “Trends in mesenchymal stem cell clinical trials 2004-2018: Is efficacy optimal in a narrow dose range?” Stem Cells Translational Medicine 1 (2020): 17-27.
  2. Alijotas-Reig J., et al. “Immunomodulatory therapy for the management of severe COVID-19. Beyond the anti-viral therapy: A comprehensive review”. Autoimmunity Reviews 7 (2020): 102569.
  3. Prockop DJ and Oh JY. “Mesenchymal stem/stromal cells (MSCs): role as guardians of inflammation”. Molecular Therapy 1 (2012): 14-20.
  4. Galipeau J and Sensebe L. “Mesenchymal Stromal Cells: Clinical Challenges and Therapeutic Opportunities”. Cell Stem Cell6 (2018): 824-833.
  5. Hess DC., et al. “Safety and efficacy of multipotent adult progenitor cells in acute ischaemic stroke (MASTERS): a randomised, double-blind, placebo-controlled, phase 2 trial”. The Lancet Neurology 5 (2017): 360-368.
  6. Winkler T., et al. “Immunomodulatory placental-expanded, mesenchymal stromal cells improve muscle function following hip arthroplasty”. Journal of Cachexia, Sarcopenia and Muscle 5 (2018): 880-897.
  7. Metcalfe SM. “Mesenchymal stem cells and management of COVID-19 pneumonia”. Medicine in Drug Discovery 5 (2020): 100019.
  8. Leng Z., et al. “Transplantation of ACE2(-) Mesenchymal Stem Cells Improves the Outcome of Patients with COVID-19 Pneumonia”. Aging and Disease 2 (2020): 216-228.
  9. Norgren L., et al. “PLX-PAD Cell Treatment of Critical Limb Ischaemia: Rationale and Design of the PACE Trial”. European Journal of Vascular and Endovascular Surgery 4 (2019): 538-545.
  10. Hess DC., et al. “A double-blind placebo-controlled clinical evaluation of MultiStem for the treatment of ischemic stroke”. International Journal of Stroke 3 (2014): 381-386.
  11. Kurtzberg J., et al. “A Phase 3, Single-Arm, Prospective Study of Remestemcel-L, Ex Vivo Culture-Expanded Adult Human Mesenchymal Stromal Cells for the Treatment of Pediatric Patients Who Failed to Respond to Steroid Treatment for Acute Graft-versus-Host Disease”. Biology of Blood and Marrow Transplantation 5 (2020): 845-854.
  12. Kumar S., et al. “Sizes and Sufficient Quantities of MSC Microspheres for Intrathecal Injection to Modulate Inflammation in Spinal Cord Injury”. Nano Life4 (2015): 1550004.
  13. Marrazzo P., et al. “Exploring the roles of MSCs in infections: focus on bacterial diseases”. Journal of Molecular Medicine 4 (2019): 437-450.
  14. Yen BL., et al. “Current status of mesenchymal stem cell therapy for immune/inflammatory lung disorders: Gleaning insights for possible use in COVID-19”. Stem Cells Translational Medicine 10 (2020): 1163-1173.
Citation: John Loike., et al. “The Path to FDA Approval of MSC Therapy Will be Accelerated by COVID-19”. EC Microbiology 16.11 (2020): 01-05.

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