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Mesenchymal stromal cell therapy for coronavirus disease 2019: which? when? and how much?
Pradnya Shahani1, Indrani Datta1
1Department of Biophysics, National Institute of Mental Health and Neurosciences, Bengaluru, India.
Abstract:
Mesenchymal stromal cells (MSCs) are under active consideration as a treatment strategy for controlling the hyper-inflammation and slow disease progression associated with coronavirus disease 2019 (COVID-19). The possible mechanism of protection through their immunoregulatory and paracrine action has been reviewed extensively. However, the importance of process control in achieving consistent cell quality, maximum safety and efficacy-for which the three key questions are which, when and how much-remains unaddressed. Any commonality, if it exists, in ongoing clinical trials has yet to be analyzed and reviewed. In this review, the authors have therefore compiled study design data from ongoing clinical trials to address the key questions of "which" with regard to tissue source, donor profile, isolation technique, culture conditions, long-term culture and cryopreservation of MSCs; "when" with regard to defining the transplantation window by identifying and staging patients based on their pro-inflammatory profile; and "how much" with regard to the number of cells in a single administration, number of doses and route of transplantation. To homogenize MSC therapy for COVID-19 on a global scale and to make it readily available in large numbers, a shared understanding and uniform agreement with respect to these fundamental issues are essential.
Insights
Mesenchymal stromal cells (MSCs) show promise for treating COVID-19 hyper-inflammation. This review analyzes clinical trials to standardize MSC therapy, focusing on cell source, timing, and dosage for consistent quality and efficacy.
Area of Science:
- Immunology
- Regenerative Medicine
- Infectious Diseases
Background:
- Mesenchymal stromal cells (MSCs) are investigated for their immunomodulatory and paracrine effects in managing COVID-19 hyper-inflammation and disease progression.
- Existing research extensively covers MSC mechanisms but lacks standardization in clinical application, particularly regarding process control for consistent cell quality, safety, and efficacy.
Purpose of the Study:
- To address critical gaps in mesenchymal stromal cell (MSC) therapy for COVID-19 by analyzing ongoing clinical trials.
- To establish a shared understanding and uniform agreement on key parameters for homogenizing MSC therapy globally.
Main Methods:
- Compilation and analysis of study design data from ongoing clinical trials involving MSCs for COVID-19 treatment.
- Focus on "which" (tissue source, donor, isolation, culture, cryopreservation), "when" (transplantation window based on patient inflammatory profile), and "how much" (cell dose, number of doses, route).
Main Results:
- Identified key variables in MSC therapy design across clinical trials, including tissue source, donor characteristics, isolation methods, culture conditions, and cryopreservation techniques.
- Highlighted the need to define patient stratification based on inflammatory profiles for optimal transplantation timing and to standardize cell dosage and administration routes.
Conclusions:
- Standardization of "which," "when," and "how much" parameters is essential for consistent mesenchymal stromal cell (MSC) quality, safety, and efficacy in COVID-19 treatment.
- A uniform approach to MSC therapy is crucial for global accessibility and successful clinical outcomes in managing coronavirus disease 2019.
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