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Shattering barriers toward clinically meaningful MSC therapies
Oren Levy1, Rui Kuai1,2, Erika M J Siren1
1Center for Nanomedicine and Division of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Harvard-MIT Division of Health Sciences and Technology, Boston, MA, USA.
Science Advances
|August 25, 2020
Summary
Mesenchymal stromal cells (MSCs) show promise in over 1050 clinical trials, but many therapies fail efficacy endpoints. Bioengineering strategies are needed to enhance MSC potency and overcome clinical translation challenges.
Area of Science:
- Cellular and Molecular Medicine
- Regenerative Medicine
- Biotechnology
Background:
- Over 1050 clinical trials investigate multipotent mesenchymal stromal cells (MSCs) for diverse applications like neurodegenerative disorders, COVID-19, and cancer.
- Despite commercialization efforts, most MSC therapies fail to meet primary efficacy endpoints in clinical trials.
- The therapeutic efficacy of MSCs in humans is often less robust than observed in preclinical studies, hindering translation.
Purpose of the Study:
- To review the major clinical challenges hindering the success of MSC-based therapies.
- To detail the specific obstacles encountered during the clinical translation of MSC therapies.
- To explore bioengineering approaches to enhance MSC therapeutic potential and versatility.
Main Methods:
- Review of clinical trial data and scientific literature on MSC therapies.
- Analysis of factors contributing to heterogeneity and reduced efficacy in MSC translation.
- Discussion of bioengineering strategies to leverage MSC biology for improved therapeutic outcomes.
Main Results:
- Clinical translation of MSCs is impeded by heterogeneity and reduced in vivo potency compared to preclinical data.
- Numerous MSC-based therapies face challenges in meeting primary efficacy endpoints.
- Bioengineering offers potential solutions to enhance MSC function and overcome clinical hurdles.
Conclusions:
- Significant challenges exist in translating MSC therapies to clinical success.
- Addressing heterogeneity and enhancing MSC potency through bioengineering are crucial for future therapeutic development.
- Leveraging MSC biology via innovative approaches can lead to more potent and versatile cell-based treatments.
