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Cell-based therapies for coronavirus disease 2019: proper clinical investigations are essential
Maroun Khoury1, Patricia R M Rocco2, Donald G Phinney3
1Laboratory of Nano-Regenerative Medicine, Faculty of Medicine, Universidad de los Andes, Santiago, Chile; Cells for Cells and Consorcio Regenero, Chilean Consortium for Regenerative Medicine, Santiago, Chile.
Abstract:
The serious consequences of the global coronavirus disease 2019 (COVID-19) pandemic have prompted a rapid global response to develop effective therapies that can lessen disease severity in infected patients. Cell-based approaches, primarily using mesenchymal stromal cells (MSCs), have demonstrated a strong safety profile and possible efficacy in patients with acute respiratory distress syndrome (ARDS), but whether these therapies are effective for treating respiratory virus-induced ARDS is unknown. According to the World Health Organization International Clinical Trials Registry Platform and the National Institutes of Health ClinicalTrials.gov databases, 27 clinical investigations of MSC-based cell therapy approaches have begun in China since the onset of the COVID-19 outbreak, with a growing number of academic and industry trials elsewhere as well. Several recent published reports have suggested potential efficacy; however, the available data presented are either anecdotal or from incomplete, poorly controlled investigations. Therefore, although there may be a potential role for MSCs and other cell-based therapies in treatment of COVID-19, these need to be investigated in a rationally designed, controlled approach if safety and efficacy are to be demonstrated accurately. The authors urge that the field proceed by finding a balance between swift experimentation and communication of results and scientifically coherent generation and analysis of clinical data.
Insights
Mesenchymal stromal cell (MSC) therapies show promise for treating COVID-19 respiratory distress. However, rigorous, controlled clinical trials are essential to confirm their safety and efficacy in patients with virus-induced acute respiratory distress syndrome.
Area of Science:
- Immunology
- Regenerative Medicine
- Virology
Background:
- The COVID-19 pandemic necessitates urgent development of effective treatments for severe respiratory illness.
- Mesenchymal stromal cells (MSCs) have a favorable safety profile and potential efficacy in acute respiratory distress syndrome (ARDS).
- The effectiveness of MSC-based therapies for virus-induced ARDS, including COVID-19, remains unproven.
Purpose of the Study:
- To evaluate the current landscape of clinical investigations into MSC-based therapies for COVID-19.
- To highlight the need for scientifically rigorous, controlled studies to establish the safety and efficacy of MSCs in treating COVID-19-associated ARDS.
- To advocate for a balanced approach between rapid research and robust data generation.
Main Methods:
- Review of clinical trial databases (WHO ICTRP, ClinicalTrials.gov) for MSC-based COVID-19 therapies.
- Analysis of existing published reports on MSC efficacy in COVID-19.
- Assessment of the quality and control of current investigations.
Main Results:
- 27 clinical trials of MSC-based therapies initiated in China since the COVID-19 outbreak, with increasing global interest.
- Published data suggesting potential MSC efficacy are largely anecdotal or from poorly controlled studies.
- A significant number of ongoing trials require scientifically coherent design and data analysis.
Conclusions:
- While MSCs hold therapeutic potential for COVID-19, their efficacy and safety require validation through well-designed clinical trials.
- Current evidence is insufficient to confirm the benefits of MSCs for respiratory virus-induced ARDS.
- Future research must prioritize controlled investigations to accurately demonstrate the safety and efficacy of cell-based therapies in COVID-19 patients.
