'Technical specification for haemocompatibility assessment of human mesenchymal stem cells' is the first set of guidelines on haemocompatibility assessment of human mesenchymal stem cells (MSCs) in China, jointly drafted and agreed upon by experts from the Chinese Society for Stem Cell Research. This standard outlines the methods for assessing the hemocompatibility of human mesenchymal stem cells and specifies the requirements for the selection of evaluation indicators, calculation of indicator values, and determination of hemocompatibility levels. It is applicable for evaluating the hemocompatibility of MSCs prior to their contact with blood. This guideline was originally released by the Chinese Society for Cell Biology on October 28, 2024. We anticipate that the publication of this specification will promote the institutional adoption, acceptance, and execution of proper testing protocols, thereby accelerating the international standardization of MSCs for clinical development and therapeutic applications.

This guideline provides standardized requirements and quality control measures for human gallbladder cancer organoids, supporting their reliable application in research and precision medicine. It aims to promote methodological consistency, facilitate international collaboration, and accelerate translational research and clinical implementation.

This guideline establishes a comprehensive framework for the application of patient-derived pancreatic cancer organoids. It outlines the stringent technical requirements and testing methods necessary to ensure high fidelity to the original tumor tissue, including morphological assessment, pathological biomarker expression (e.g., CK19, CK7), and genetic concordance (e.g., NRG1, KRAS). By standardizing protocols for in vitro culture, microbiological safety, and STR authentication, this consensus aims to ensure the reproducibility, safety, and stability of organoid models, thereby accelerating their integration into basic research, drug discovery, and precision medicine.

Residual PSC detection follows ultra‑trace‑analysis principles. LOD supports qualitative assessment. Assays employ PSC‑specific markers and proper references, with adaptation to differentiated cell populations from diverse PSC sources.

The overlap HPLC chromatograms of ATP standard (red) and ATP in cells (blue). Poroshell 120 EC-C18 (3 × 150 mm, 2.7 μm), 25°C, pH 6.8 buffer solution of 0.05 mol/L KH2PO4 - 0.05 mol/L K2HPO4 (V:V = 1:1) as mobile phase, 0.6 mL/min, 254 nm.

Huaier (Trametes Robiniophila Murr), a traditional Chinese medicine, has emerged as a promising therapeutic agent against cancers in clinical settings, yet its underlying mechanisms remain elusive. In this study, we demonstrate that Huaier effectively suppresses lung cancer by inducing ferroptosis. Mechanistically, Huaier simultaneously and independently downregulates the antioxidant pathway SLC7A11/GPX4 and elevates intracellular iron levels through NCOA4-mediated ferritinophagy degradation of FTH1 in lung cancer cells. Both the iron chelator deferoxamine (DFO) and the ferroptosis inhibitor ferrostatin-1 (Fer-1) mitigate Huaier-induced cell death. In both urethane-induced lung tumorigenesis models and cell-derived xenograft (CDX) models, Huaier significantly inhibits tumor progression by inducing ferroptosis, which can be counteracted by SRS16-86. Our study uncovers a novel mechanism by which Huaier induces ferroptosis to suppress lung cancer, underscoring its potential as a therapeutic agent for lung cancer or as part of a combination therapy strategy.

Pluripotent stem cells (hPSCs) possess the unique ability to self-renew and differentiate into various functional cell types, positioning them as key "seed cells" in regenerative medicine. The development of PSC-based therapies offers new hope for treating complex diseases, and degenerative diseases, particularly those caused by the loss of specific cellular functions, such as macular degeneration, Parkinson's disease, spinal cord injury, diabetes, and cartilage damage. Cell replacement therapies using hPSC-committed cells can help halt disease progression or potentially cure these conditions. The Retinal Pigment Epithelium (RPE) is crucial for visual function and photoreceptor support, with its dysfunction implicated in age-related macular degeneration (AMD) and retinitis pigmentosa (RP). Parkinson's disease (PD), a rapidly progressing neurodegenerative disorder marked by the loss of midbrain dopaminergic neurons (mDA), remains one of the most difficult neurological conditions to treat. Traditional therapies for these diseases have largely been ineffective. RPE and mDA neurons differentiated from hPSCs offer promising solutions for treating AMD and PD, their treatment methods are both cell replacement therapy, and they are the products used in the first batch of stem cell clinical research registration projects in China, so we will put these two products together. This chapter summarizes the differentiation and quality control strategies for hESC-derived RPE and mDA neurons as examples of the potential hPSC-derived cell therapies, under development at the Chinese Academy of Sciences and Beijing Institute for Stem Cell and Regenerative Medicine, for these complex, treatment-resistant diseases.

Human embryonic stem cells (hESCs) play a critical role in advancing regenerative medicine, with significant potential in tissue engineering, disease modeling, and cell-based therapies. Following the derivation of the first hESC line and subsequent breakthroughs in induced pluripotent stem cell (iPSC) technology, global efforts have accelerated the progress of stem cell research and clinical applications. The development of high-standard stem cell banks worldwide has ensured the traceability, quality, and accessibility of these critical resources, enabling their safe translation to clinical use. The National Stem Cell Resource Center (NSCRC) advances the efforts in arranging and optimizing stem cell resources to support research and clinical needs. Through rigorous quality control system construction and encouraging innovation, the NSCRC has been accredited by ISO 20387 and ISO 17025. Now, the NSCRC has developed a broad spectrum of high-quality stem cell lines, securing independent intellectual property rights. These resources have facilitated clinical research, supported major scientific initiatives, and provided good practice experience for the international standardization of stem cells. Moreover, the focus on integrating organoid resources and establishing intelligent biobanks highlights the frontier correlation of stem cell research, promoting innovation, collaboration, and clinical translation to meet unmet medical needs.

Chimeric antigen receptor (CAR) T cell therapy has emerged as a promising approach for hematological malignancies, yet its efficacy in solid tumors is hindered by limited persistence. To address this, immune checkpoint inhibitors (ICIs) and cytokines have been explored as potential solutions. In this study, we developed a novel monoclonal antibody (mAb), m8A8, which exhibits high specificity for human PD-1 and effectively disrupts its ligand interactions. Furthermore, we engineered CAR-T cells to express human IL-7, resulting in enhanced anti-tumor efficacy in xenograft models. Additionally, the human-mouse chimeric antibody C8A8, derived from m8A8, was found to significantly amplify the anti-tumor activity of IL-7-engineered CAR-T cells. Our findings provide compelling evidence and a robust rationale for the synergistic integration of ICIs, cytokines, and CAR-T cell therapy in the treatment of solid tumors.

As cell-based therapies near widespread clinical use, robust data management systems are crucial for ensuring safety, efficacy, and regulatory compliance. This chapter reviews the ISO 8472 series, which focuses on data interoperability for stem cell applications, and highlights the complexities of managing clinical, manufacturing, and quality control data. It underscores the need for standardized frameworks to streamline data sharing, analysis, and validation. Additionally, emerging technologies like AI and blockchain are explored for their potential to revolutionize data management, enhance security, and improve automation. Furthermore, this chapter addresses challenges in implementing data standards in cell therapy manufacturing and ensuring transparency. It outlines strategies to foster collaboration among stakeholders, including regulatory bodies, biobanks, CROs, and manufacturers, to drive innovation and scalability. Establishing comprehensive standards and interoperable data systems is essential for building trust and facilitating the commercialization of stem cell therapies.

The global surge in the population of people 60 years and older, including that in China, challenges healthcare systems with rising age‐related diseases. To address this demographic change, the Aging Biomarker Consortium (ABC) has launched the X-Age Project to develop a comprehensive aging evaluation system tailored to the Chinese population. Our goal is to identify robust biomarkers and construct composite aging clocks that capture biological age, defined as an individual’s physiological and molecular state, across diverse Chinese cohorts. This Perspective outlines the core objectives, methodological framework and key deliverables of the X-Age Project, including cohort recruitment, standardized sample collection, multimodal data acquisition and clock model development. By integrating interdisciplinary expertise, we aim to provide a practical and scalable platform for understanding aging complexity and heterogeneity, early detection of accelerated aging and evaluation of aging interventions. In this Perspective, members of the Aging Biomarker Consortium outline the X-Age Project, an Aging Biomarker Consortium plan for building standardized aging clocks in China. The authors discuss the project roadmap and its aims of decoding aging heterogeneity, detecting accelerated aging early and evaluating geroprotective interventions.

Although Chimeric antigen receptor (CAR) T-cell therapy has achieved remarkable success in treating hematopoietic malignancies, its clinical application in solid tumors is profoundly hindered by persistent T-cell exhaustion within the immunosuppressive tumor microenvironment (TME). Here, we identified SATB1—a genome organizer regulating chromatin architecture—as a key suppressor of CAR-T cell exhaustion. In Glypican-3 (GPC3)-targeted CAR-T cells, SATB1 was significantly downregulated in tumor-infiltrating exhausted populations. SATB1 overexpression not only reduced expression of multiple inhibitory receptors (PD-1, CTLA-4, TIM3, and LAG-3) but also promoted a central memory phenotype, enhancing cytokine production and cytotoxicity against hepatocellular carcinoma (HCC) cells in vitro. In vivo, SATB1-engineered CAR-T cells exhibited superior tumor control and promoted survival, accompanied by reduced exhaustion markers in tumor-infiltrating T cells. These functional improvements are consistent with the reported role of SATB1 in modulating T cell exhaustion, positioning it as a multifunctional enhancer of CAR-T cell fitness. Collectively, our study unveils SATB1 as a multifunctional modulator that simultaneously targets exhaustion and memory differentiation, offering a novel strategy to enhance CAR-T efficacy against solid tumors.

Stem cells hold tremendous promise for regenerative medicine. With continuous development in this field, stem cell medicines are starting to enter mainstream drug development. Due to their distinct and complex characteristics, which are significantly different from those of traditional medicine, new opportunities and challenges are arising in stem cell medicine development. Therefore, to facilitate the clinical translation of stem cells and adapt to scientific and technological progress, it is important to formulate and update regulatory policies and standards that are specifically appropriate for cell therapy. In this section, we discuss the regulatory policies on stem cell medicine and drug standards in China, and review the ongoing development of international and Chinese standards related to stem cell medicine. Finally, we discuss the framework for establishing a standard system for stem cell medicine in the future.

Cells face two challenges after transplantation: recognition and killing by lymphocytes, and cell apoptosis induced by the transplantation environment. Our hypoimmune cells aim to address these two challenges through editing of immunomodulatory proteins and overexpression of anti-apoptotic proteins.