Plain-language summary
Regenerative dentistry has produced a fast-growing literature on dental pulp stem cells (DPSCs), stem cells from human exfoliated deciduous teeth (SHED) and the extracellular vesicles (EVs) they release, yet it rarely asks whether any of this is ready to become a product. This systematic scoping review set out to build that map. Following JBI and PRISMA-ScR guidance, the authors combined two high-coverage reviews with an update to mid-July 2026, charting 52 primary reports plus nine methodological sources. Scaffold-based DPSC and SHED work generally favoured cell-containing constructs, but most studies were short-term animal experiments. Small human studies of autologous DPSC or SHED products reported encouraging feasibility and few serious safety signals, yet were too small to demonstrate effectiveness. Dental EV research remained almost entirely preclinical: isolation methods, particle-normalised dosing, potency, storage, biodistribution and batch comparability were routinely incomplete. Appraising the evidence across nine domains, the authors judged readiness highest for autologous DPSC pulp products, intermediate for scaffold-based bone or periodontal products, and low for dental EV products. Before confirmatory trials, they argue, the field needs indication-specific potency assays, carrier and product codevelopment, dose-response and biodistribution data, standardised outcomes, long-term safety follow-up and explicit GMP and regulatory plans.
Key findings
- The review charted 52 primary reports on dental pulp stem cell (DPSC), SHED and extracellular-vesicle products across nine appraisal domains, from source material and characterisation through dosing, delivery, safety and regulation.
- Scaffold-based DPSC and SHED studies generally favoured cell-containing constructs, but most were short-term animal experiments with heterogeneous designs.
- Small human studies of autologous DPSC or SHED products reported encouraging feasibility and few serious safety signals, yet were underpowered to show effectiveness or detect uncommon harms.
- Dental extracellular-vesicle evidence remains predominantly preclinical, and the authors rate relative readiness as highest for autologous DPSC pulp products, intermediate for scaffold-based bone or periodontal products, and low for dental EV products.
Original abstract
Dental pulp stem cells (DPSCs), stem cells from human exfoliated deciduous teeth (SHED), and extracellular vesicles (EVs) show regenerative potential, but clinical translation depends on a reproducible product-process-procedure system. This systematic scoping review mapped how DPSC- and EV-containing dental products are defined, manufactured, formulated, dosed, delivered, monitored, and regulated. Following Joanna Briggs Institute guidance (JBI) and Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR), an umbrella-assisted strategy combined two recent high-coverage reviews with a targeted update through July 15, 2026. Data were charted for source, characterization, carrier, dose, delivery, visualization, safety, outcomes, and manufacturing readiness; a nine-domain review-level framework (Translational Readiness Appraisal for Dental cell and EV products) summarized relative maturity without serving as a validated clinical score. The map comprised 52 unique primary reports and nine methodological or secondary sources. Scaffold-based DPSC/SHED studies generally favored cell-containing constructs, but most were heterogeneous short-term animal experiments. Small human studies of autologous DPSC or SHED products reported encouraging feasibility and few serious safety signals, yet were underpowered for effectiveness or uncommon harms. Dental EV evidence remained predominantly preclinical; isolation, particle-normalized dosing, potency, storage, biodistribution, and batch comparability were frequently incomplete. Magnification was not consistently standardized as a delivery variable. Relative readiness was highest for autologous DPSC pulp products, intermediate for DPSC-scaffold bone or periodontal products, and low for dental EV products. Translation now requires indication-specific potency assays, carrier-product codevelopment, dose-response and biodistribution studies, documented delivery fidelity, standardized outcomes, long-term safety follow-up, and explicit good manufacturing practice (GMP) and regulatory strategies before confirmatory trials.
Frequently asked questions
What did this study find?
Regenerative dentistry has produced a fast-growing literature on dental pulp stem cells (DPSCs), stem cells from human exfoliated deciduous teeth (SHED) and the extracellular vesicles (EVs) they release, yet it rarely asks whether any of this is ready to become a product. This systematic scoping review set out to build that map. Following JBI and PRISMA-ScR guidance, the authors combined two high-coverage reviews with an update to mid-July 2026, charting 52 primary reports plus nine methodological sources. Scaffold-based DPSC and SHED work generally favoured cell-containing constructs, but most studies were short-term animal experiments. Small human studies of autologous DPSC or SHED products reported encouraging feasibility and few serious safety signals, yet were too small to demonstrate effectiveness. Dental EV research remained almost entirely preclinical: isolation methods, particle-normalised dosing, potency, storage, biodistribution and batch comparability were routinely incomplete. Appraising the evidence across nine domains, the authors judged readiness highest for autologous DPSC pulp products, intermediate for scaffold-based bone or periodontal products, and low for dental EV products. Before confirmatory trials, they argue, the field needs indication-specific potency assays, carrier and product codevelopment, dose-response and biodistribution data, standardised outcomes, long-term safety follow-up and explicit GMP and regulatory plans.
Was this tested in humans or in the laboratory?
This is a review: it summarises and weighs up previously published studies rather than presenting new experiments.
Where can I read the original paper?
The full text lives with the publisher: https://doi.org/10.1177/15473287261496095
How to cite this paper
Kurmanalina Madina A, Tamadon Amin, Ismagulova Elnara K, Aitmukhanbetova Aruzhan M, Safarzoda Sharoffidin Ramazon. Translational Readiness of Dental Pulp Stem Cell and Extracellular-Vesicle Products: Manufacturing, Delivery, Safety, and Clinical Development.. Stem cells and development. 2026, 2026-10-12. DOI: 10.1177/15473287261496095
Source & verification
- Journal: Stem cells and development
- Published: 12 October 2026
- DOI: 10.1177/15473287261496095
- PubMed ID: 42861854
- Indexed via: pubmed
- MeSH terms: —