Regenerative Medicine in the Bronze Age: MSCs and MSC-EVs Leading the Way

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Immunotherapies have dominated cell and gene therapy for the past 5–10 years, but the field of regenerative medicine is gaining momentum. Mesenchymal stem cells (MSCs) remain central to this field, with expanding applications as direct therapies and as producers of MSC-derived extracellular vesicles (MSC-EVs). This article examines the biological and regulatory factors shaping their promise.

MSC Therapies: Promise, Frustration, and a Push Toward Biomarkers to Drive Efficacy

MSC therapies show strong biological promise, but translation remains slow because efficacy and consistency are difficult to demonstrate. A key priority is aligning therapy design with MSC biology. Autoimmune diseases, such as progressive multiple sclerosis, are strong applications because treatment options are limited and early studies suggest MSCs may help reset immunity. Experts recommend biomarker-driven trials to identify appropriate patients earlier and improve evaluation. MSCs are often misunderstood and underutilized, making biomarker-driven design and global harmonization essential for success.

MSCs are attractive because they can be used in allogeneic therapies: donor cells can be cryopreserved, thawed, and used off-the-shelf to treat larger patient populations, including autoimmune and cardiovascular indications. Developers are moving toward 3D culture systems to increase production, simplify manufacturing, and enable MSC-EV generation. However, shifting from 2D to 3D culture systems can alter confluency, marker profiles, EV productivity, and other critical quality attributes. Teams must optimize media, serum or HPL, additives, and reagents to maintain CQAs at scale.

Process changes in media, microcarriers, or feed schedules can dramatically affect MSC performance, increasing interest in AI-driven optimization of consumables and reagents. As 3D systems advance, developers still rely on serum or HPL to support cell health and consistency, while the industry increasingly demands chemically defined, serum-free systems. Better serum-free and HPL-free solutions are needed for clinical development of MSC therapies and MSC-EVs. Together, these trends show MSC therapies becoming more engineered, precise, and clinically defined, while many MSC developers expand into MSC-EV solutions and fuel excitement around both modalities.

MSC-EVs: Increasing Interest in a Novel Therapeutic Solution

The shift of MSC-EVs from “cells as drugs” to “cells as biological triggers” raises an interesting central question: can developers deliver therapeutic impact without administering the cells themselves?

With more than 500 MSC-derived EV clinical trials underway, the field continues to grow. MSC-EVs lead the EV and exosome space because of the strong foundation built during decades of MSC research. However, key questions remain around classification, safety, efficacy, scale-up, and commercialization. MSC-EVs remain in a regulatory grey zone, with agencies still determining whether they are biologics, cell-based therapies, or a new class. Regulators are likely to focus on process consistency, EV identity, and release testing in later-stage development.

Purity and characterization remain central because upstream and downstream processes can change EV composition. Each indication must show how cell source, processing, and purification affect the final product. With no commercial EV therapeutics approved so far, developers must establish precedent while maintaining consistency through scale-up. As MSC-EV developers scale into larger trials and commercial manufacturing, GMP processes and reagents can change EV outputs and must be addressed early. Early conversion to GMP media and consumables can reduce risk, lower costs, and clarify efficacy, purity, and consistency priorities. MSC-EVs will also face competition from EVs derived from NK cells, macrophages, HEK293 cells, plants, and other sources. These alternatives may offer lower-cost production or different applications, while shared learnings can advance the broader EV field.

MSCs and MSC-EVs Drive Progress and Advance Regenerative Medicine

Immunotherapies have defined a recent Golden Age in cell and gene therapy. As manufacturing matures and refinements become more incremental, the next major wave of innovation may come from regenerative medicine. MSCs and MSC-EVs hold major promise, but many companies still lack the infrastructure and timelines that attract major pharma investment. This places the field in a biotech Bronze Age: rich with opportunity in rare disease, organ failure, allogeneic therapies, and scalable EV platforms, but still building the evidence, biology, and manufacturing precedent needed for broader success. Continued progress in scale-up, process control, and modality definition could unlock a future Golden Age for MSC and MSC-EV therapeutics.

Jessica Pickrell; Associate Director, Media Solutions, Lonza

Further Reading

1. Wang CK, Tsai TH, Lee CH. Regulation of exosomes as biologic medicines: Regulatory challenges faced in exosome development and manufacturing processes. Clin Transl Sci. 2024; Aug 17(8):e13904. doi: 10.1111/cts.13904. PMID: 39115257; PMCID: PMC11307316.

2. Bourcier AJ & Kirkor ZM. Regulatory, ethical, and clinical barriers to exosome use in interventional pain medicine. Intl Pain Medicine 2026; 5(1):100746. doi: 10.1016/j.inpm.2026.100746.

3. nternational Society for Cell & Gene Therapy (ISCT). 2026. Roundtable on Regulation and Policy, ISCT 2026 Annual Meeting, Dublin, Ireland.

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