时间标签：数据日期 2026-11-05 · 生成时间 2026-11-05 05:30（Asia/Shanghai）｜ 检索窗口 PubMed edat 2026/11/02 – 2026/11/06 ｜ 情报发生日期 2026-11-05
研究问题
We hypothesize that this gap may be attributable in significant part to product-level design challenges—insufficient definition of source, manufacturing, formulation, delivery, potency, and patient selection—rather than to a fundamental lack of MSC biological activity.；This underreporting prevents objective comparison of product differences across studies and is itself a major barrier to identifying which product attributes drive clinical efficacy.4.2Cell, EV, or combination productViable MSC products retain adaptive sensing capacity: inflammatory or hypoxic licensing can amplify immunomodulatory and angiogenic signals.；Whether formal sequential strategies—debridement/antimicrobials followed by staged EV dosing, or phase-matched anti-inflammatory then pro-angiogenic formulations—are necessary remains open.
方法
This definition is useful for diagnosis but misleading for therapy, because it implies a simple delay in a normal sequence.；We hypothesize that this gap may be attributable in significant part to product-level design challenges—insufficient definition of source, manufacturing, formulation, delivery, potency, and patient selection—rather than to a fundamental lack of MSC biological activity.；Most studies still ask “do MSCs work?” rather than “which MSC product, for which wound phenotype, delivered by which system, measured by which potency assay, and tested against which endpoint?”.This review therefore reframes MSC/MSC-EV therapy for chronic wounds as a product-design and translational problem anchored in three linked core questions.
核心结论
Third, which clinical trial design and endpoints can demonstrate patient-relevant benefit rather than mere biological plausibility?；However, our analysis of the chronic wound MSC trials summarized in Table 4 reveals that many of these consensus variables—particularly donor characteristics, isolation/expansion details, full immunophenotyping, viability at release, post-thaw recovery, and functional potency assays—are underreported or absent.；First, the generic term “extracellular vesicle (EV)” should be used rather than “exosome” unless the biogenesis pathway has been definitively demonstrated, which is rarely the case in wound-healing studies.
局限
However, the relationship between MSC persistence, viability, and therapeutic function remains complex and incompletely understood, and the minimal duration and viability threshold for meaningful clinical effect have not been established.However, despite hundreds of preclinical studies and a growing number of early-phase clinical trials, no MSC or MSC-EV product has yet received regulatory approval for chronic wounds as a primary indication.；This hypothesis remains to be rigorously tested in adequately powered, product-specific clinical trials, and biological variability, patient heterogeneity, and trial design limitations likely also contribute.；This remains a conceptual framework rather than a definitively established mechanism, though it is consistent with the pleiotropic nature of wound repair biology.However, from a translational perspective, pleiotropy becomes a major liability unless the intended mechanism of action (MoA) is defined and measurable.
对本项目的价值
中高价值：属「衰老细胞清除 / SASP 轴」方向；细胞衰老 / senolytics / SASP栏目可用作本项目文献库与综述素材。 ｜ 价值分 3.1/5（★★★☆☆）
全文来源
PubMed PMC JATS（正文 65,588 字符，题名指纹 0.92，已过 PubMed PMCID 官方关联 + 题名指纹 + 正文长度归属校验）
原文题录
- 中文题名：MSC/MSC-EV 治疗慢性创面：微环境重编程、产品设计到临床转化
- 英文标题：MSC/MSC-EV therapy for chronic wounds: microenvironmental reprogramming, product design, and clinical translation.
- 期刊与标识：Frontiers in bioengineering and biotechnology · PMID 42974021 · DOI 10.3389/fbioe.2026.1960442 · PMC PMC13725077