FDA approves the use of stem cells for COVID - 19 clinical trials

Stem cells are a type of cell that can form different types of cells found in humans. Stem cells begin to divide to form more stem cells or other cells that perform specific functions. This is known because they are investigational products that have been studied extensively for many clinical applications in  regenerative medicine. It has been hypothesized that stem cells could reduce acute lung injury and inhibit the cell-mediated inflammatory response induced by COVID 19.

Notably, the Food and Drug Administration (FDA) has not approved any stem cell products to treat COVID-19. They should only be used at this time for clinical trials supported by this organization.

An intravenous stem cell transplant study in China enrolled 10 COVID-19 patients. The patients were the following: One with critical illness, four with severe illness, and two with the common-type disease received the stem cells, while the last three out of the ten only received placebo. The stem cell patients gradually improved, while those using placebo remained stable with severe illness, another with acute respiratory distress syndrome, and the last one died.

Based on this, the FDA gave the green light to use stem cells but only used in clinical trials and only approved by them. This is to have better control and analyze more closely this type of regenerative medicine.



GIOSTAR Announces FDA Approval Under Compassionate Use for a COVID-19 with Stem Cells, available at:


Leng Z, Zhu R, Hou W, et al. Transplantation of ACE2(-) mesenchymal stem cells improves the outcome of patients with COVID-19 pneumonia. Aging Dis. 2020;11(2):216-228. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32257537