Escuela de Medicina y Ciencias de la Salud, Tecnologico de Monterrey, Monterrey, NL, México.
Innbiogem SC en el Laboratorio Nacional de Servicios Especializados de Investigación, Desarrollo e Innovación en Medicamentos Químicos y Biotecnológicos CONACyT, Monterrey, NL, México.
Arch Med Res. 2021 Jan;52(1):93-101. doi: 10.1016/j.arcmed.2020.08.006. Epub 2020 Sep 22.
Human Mesenchymal Stem Cells (hMSCs) are multipotent stem cells capable of renewing themselves and differentiation in vitro into different kinds of tissues. In vivo hMSCs are sources of trophic factors modulating the immune system and inducing intrinsic stem cells to repair damaged tissues. Currently, there are multiple clinical trials (CT) using hMSCs for therapeutic purposes in a large number of clinical settings.
The search strategy on clinicaltrials.gov has focused on the key term "Mesenchymal Stem Cells", and the inclusion and exclusion criteria were separated into two stages. Stage 1, CT on phases 1-4: location, the field of application, phase, and status. For stage 2, CT that have published outcome results: field of application, treatment, intervention model, source, preparation methods, and results.
By July 2020, there were a total of 1,138 registered CT. Most studies belong to either phase 2 (61.0%) or phase 1 (30.8%); most of them focused in the fields of traumatology, neurology, cardiology, and immunology. Only 18 clinical trials had published results: the most common source of isolation was bone marrow; the treatment varied from 1-200 M hMSCs; all of them have similar preparation methods; all of them have positive results with no serious adverse effects.
There appears to be a broad potential for the clinical use of hMSCs with no reported serious adverse events. There are many trials in progress, their future results will help to explore the therapeutic potential of these promising cellular sources of medicinal signals.
人类间充质干细胞（hMSCs）是多能干细胞，能够自我更新，并在体外分化为不同类型的组织。在体内，hMSCs 是调节免疫系统和诱导内在干细胞修复受损组织的营养因子的来源。目前，有多个临床试验（CT）使用 hMSCs 作为治疗目的，应用于大量临床环境中。
在 clinicaltrials.gov 上的搜索策略集中在关键词“间充质干细胞”上，纳入和排除标准分为两个阶段。第一阶段，1-4 期 CT：位置、应用领域、阶段和状态。第二阶段，公布了结果的 CT：应用领域、治疗、干预模型、来源、制备方法和结果。
截至 2020 年 7 月，共有 1138 项注册 CT。大多数研究属于 2 期（61.0%）或 1 期（30.8%）；大多数集中在创伤学、神经病学、心脏病学和免疫学领域。只有 18 项临床试验公布了结果：最常见的分离来源是骨髓；治疗剂量从 1-200 万 hMSCs 不等；所有的制备方法都相似；所有试验都有积极的结果，没有严重的不良事件。
hMSCs 的临床应用似乎具有广泛的潜力，没有报告严重的不良事件。有许多试验正在进行中，它们未来的结果将有助于探索这些有前途的药物信号细胞来源的治疗潜力。
