Regenerative Therapy再生治疗
Regenerative Therapy(英文缩写 REGEN THER),ISSN 2352-3204,eISSN 2352-3204,中文译名:再生治疗 是一本学术期刊。本页汇总该期刊的最新影响因子、分区信息以及最新收录于 PubMed 的文献,帮助您快速了解期刊全貌。
发文量统计区间：2025-10-01 至 2026-09-30，按本站收录文献的发表日期统计。
期刊介绍
历年影响因子趋势
| JCR 数据年份 | 影响因子 | JCR 分区 |
|---|---|---|
| 2021 | 3.651 | Q3 |
| 2022 | 4.300 | Q2 |
| 2023 | 3.400 | Q2 |
| 2024 | 3.500 | Q2 |
| 2025 | 4.000 | Q2 |
Regenerative Therapy 最新收录文献
-
1. Ambient intelligence-based framework for quantitative evaluation of cell culture operations to support standardization and training.
PMID:日期:2026-09-25The widespread implementation of cell therapy has increased the demand for stable and reproducible cell manufacturing methods. However, many cell manufacturing processes rely heavily on manual cell culture operations, and operator training remains largely dependent on subjective assessment and tacit knowledge. This limits the establishment of training targets and hinders operational standardization. Recent advances in ambient intelligence have created new opportunities for digitizing human work processes and supporting their quantitative evaluation. In this study, we developed an ambient intelligence-based framework for digitizing, visualizing, and quantitatively comparing manual cell culture operations. A defined mock seeding operation was performed by one expert with 10 years of cell culture experience and three trainees with approximately two years of experience. Videos of the operation were recorded inside a biosafety cabinet, and the dominant-hand motion was extracted using an artificial intelligence (AI)-based skeleton estimation. The resulting time-series data were converted into quantitative speed-based temporal profiles for each operation, termed Operation Profiles. To compare operations with different execution times, the similarity between each Operation Profile and the target Operation Profile derived from the expert was evaluated using fast derivative dynamic time warping (fastDDTW). Distance and gap index were used as complementary metrics to assess the waveform deviation and temporal misalignment, respectively. Skeleton estimation AI, combined with visual quality control, interpolation, and manual correction, extracted the dominant-hand motion from the operation videos and enabled the construction of interpretable Operation Profiles that reflect the internal temporal structure of the defined cell culture operation. Although all operators performed the same operation, their Operation Profiles differed, indicating operator-dependent variations in the operation patterns. Iterative feedback based on phase-specific differences from the target expert operation was associated with progressive improvement in the trainees' similarity to the target Operation Profile. This study established a framework for recording, digitizing, and quantitatively evaluating cell culture operations using ambient intelligence. These findings demonstrate that the alignment of cell culture operations toward a target expert operation can be quantitatively evaluated through an Operation Profile analysis. By enabling objective comparison of operator behavior and quantitative evaluation of alignment toward a facility-defined target operation, this approach may provide a basis for operational standardization and training support in cell manufacturing.
-
2. Pilot study of Wilms tumor 1-targeted human platelet lysate-induced antigen-presenting cells in advanced solid cancer patients.
PMID:日期:2026-09-19For the wide implementation of dendritic cell-based cancer immunotherapy, a clinical phase I study was conducted to explore its safety and tolerability using Wilms' tumor 1 (WT1) antigen-targeted human platelet lysate-induced antigen-presenting cells (WT1-HPL-APCs), developed by our team, in patients with advanced solid cancers. WT1-HPL-APCs were manufactured from apheresed peripheral blood mononuclear cells administered at 4 × 10 cells biweekly for three sessions (one course). Adverse events and the induction of WT1-specific T cells (WT1-Cytotoxic T lymphocytes [CTLs]) were evaluated. Furthermore, the potential immunoinducibility of WT1-HPL-APC was examined in vitro and regulatory T cells and monocytic myeloid-derived suppressor cells (M-MDSCs) in the tumor microenvironment (TME) and peripheral blood were assessed to monitor immune cells. The adverse events associated with WT1-HPL-APC vaccination included fever, erythema at the injection site, arthralgia, and chills, all of which were lower than grade 2 in two patients who completed three sessions. The WT1 expression levels and infiltration of CD4 T cells, CD8 T cells, and macrophages in the TME differed among the patients. In only one of the two patients with HLA-A*24:02, WT1-HPL-APC induced WT1-CTLs in vitro. Although a WT1-CTL response could not be detected following three sessions of WT1-HPL-APC administration, the percentage of M-MDSCs in the PB tended to decrease. As this pilot study included only three patients with different cancer types, evidence supporting the effectiveness or functionality of WT1-HPL-APCs remains limited. WT1-HPL-APC vaccination was tolerable among patients with advanced solid cancers. Our findings suggest that the immunoinducibility of WT1-HPL-APC vary across individuals and that the preexisting immunosuppressive environment could limit WT1-CTL induction. Future studies are warranted to determine whether WT1-HPL-APC vaccination can improve the patient's immunosuppressive environment and induce WT1-CTLs in combination with optimized chemotherapy or adjuvant therapy in large-scale clinical trials involving multiple doses. jRCTc040200005.
-
3. Genetically engineered hypoimmunogenic iPSCs: Strategies and considerations for clinical applications.
PMID:日期:2026-09-19Induced pluripotent stem cell (iPSC)-based therapies are rapidly advancing toward clinical implementation, with increasing numbers of trials and approvals for allogeneic iPSC-derived cell products. However, immune rejection remains a major barrier to the broad application of "off-the-shelf" allogeneic cell therapies for various diseases and injuries. With current advances in genetic engineering technologies, including genome editing, it is possible to establish a low-immunogenic cell product by disrupting immune recognition molecules and by overexpressing immunosuppressive factors. This review provides a comprehensive overview of current genetic engineering strategies for generating hypoimmunogenic iPS cells. Because multiplex genome editing and transgene integration may raise safety concerns, we further outline quality-control considerations for clinical-grade hypoimmunogenic iPSC products, including assessment of on-target outcomes, off-target mutations, structural variants, chromosomal abnormalities, residual editing components, and vector-related risks. Finally, we review current clinical development of genetically engineered hypoimmunogenic iPSC-derived products and discuss future challenges, including the importance of safety profiling and international regulatory harmonization. Understanding the advantages and limitations of each engineering and validation strategy will be critical for translating hypoimmunogenic iPSCs into safe, effective, and globally accessible regenerative therapies.
-
4. {"_":"Enhanced osteogenic potential of chitosan scaffolds loaded with , hydroxyapatite particles, and dental pulp stem cells in rats.","i":["Lawsonia inermis"]}
PMID:日期:2026-09-16Maxillary/alveolar bone reconstruction is vital for cleft and pre-prosthetic patients. Autogenous bone (iliac crest) is the gold standard for clefts due to its bone-forming ability. For large defects (trauma/tumor), the vascularized fibula flap is preferred for its strength and blood supply. This study investigates the physicochemical and biological properties of chitosan (Cs)-based scaffolds. Three scaffold formulations were prepared for in vitro characterization: pure Cs, Cs enriched with 8% extract (Cs-LI), and Cs combined with LI and nanohydroxyapatite (Cs-LI-HAPs). For the in vivo study, five experimental groups were evaluated in a rat mandibular defect model: sham (empty defect), control (Cs scaffold alone), Cs-LI, Cs-LI-HAPs, and Cs-LI-HAPs seeded with 1 × 10 dental pulp stem cells (DPSCs). The synthesized HAPs showed a biomimetic apatite structure confirmed by FTIR and XRD, with a particle size of 730.2 ± 38.45 nm. Scaffold characterization demonstrated that Cs-LI-HAP had superior structural integrity, featuring interconnected porosity, improved mechanical strength (17.57 ± 1.49 MPa compressive strength), and a lower degradation rate (65.48 ± 10.35% at 4 weeks) compared to Cs and Cs-LI scaffolds. In vitro tests showed that Cs-LI-HAPs had good hemocompatibility and supported DPSC growth. In vivo, CBCT and histopathological analyses revealed that the Cs-LI-HAPs-DPSCs group exhibited significantly less fibrous tissue formation and greater bone regeneration compared to other groups. The Cs-LI-HAPs scaffold showed strong bone regeneration potential, with HAPs improving strength and stability, LI enhancing cell support, and DPSCs promoting new bone formation, making it a promising platform for maxillofacial defect repair.
-
5. Platelet-rich plasma in the treatment of spinal cord injury: Mechanisms, efficacy, and clinical translation.
PMID:日期:2026-09-15Spinal cord injury (SCI) is a devastating condition of the central nervous system characterized by complex pathophysiological processes, including primary mechanical damage and secondary injury cascades, ultimately leading to permanent neurological deficits. Current standard treatments-including surgical decompression and high-dose methylprednisolone-offer limited therapeutic benefits and fail to effectively promote neuroregeneration. Platelet-rich plasma (PRP), an autologous biological derivative enriched with multiple growth factors, has demonstrated remarkable potential in tissue repair and has recently emerged as a promising therapeutic strategy for SCI. This comprehensive review systematically examines the pathophysiological characteristics of SCI and the limitations of existing treatments, with particular emphasis on the multifaceted mechanisms of PRP in SCI repair. These mechanisms include anti-inflammatory and antioxidant effects through activation of the Nrf2 signaling pathway, regulation of apoptosis, promotion of angiogenesis, and stimulation of axonal regeneration. Preclinical studies and preliminary clinical observations have consistently demonstrated that PRP administration significantly improves neurological functional recovery following SCI. However, substantial challenges impede clinical translation, including a lack of standardization in PRP preparation, an incomplete understanding of underlying mechanisms, limited efficacy of monotherapy, and a scarcity of high-quality clinical evidence. Future directions emphasize the development of combination strategies integrating PRP with biomaterials such as hydrogels or stem cells, which may represent the key to successful clinical implementation.
-
6. Metagenomic-driven predictive biosafety and contamination traceability in stem cell manufacturing: Translating outbreak genomics into regenerative medicine.
PMID:日期:2026-09-11Stem cell manufacturing and regenerative medicine laboratories are highly vulnerable to microbial contamination due to complex processing workflows, extensive manipulation, prolonged culture conditions, and continuous environmental exposure. Conventional microbiological methods remain fundamental for laboratory quality control; however, they may underestimate concealed resistance determinants, microbial diversity, contamination pathways, and transmission dynamics. Recent advances in metagenomic sequencing have transformed outbreak investigation, resistome characterization, and genomic surveillance, providing unprecedented opportunities for contamination monitoring and biosafety management. This review proposes a translational biosafety framework that integrates metagenomic surveillance with contamination traceability systems in stem cell manufacturing and regenerative medicine laboratory environments. The review discusses contamination challenges, limitations of conventional microbiological diagnostics, metagenomic surveillance approaches, predictive biosafety concepts, genomic traceability systems, corrective and preventive action (CAPA) integration, and future artificial intelligence (AI)-assisted monitoring strategies. Lessons from sequencing-based outbreak investigations involving multidrug-resistant microorganisms highlight the potential utility of metagenomic surveillance for early detection of contamination, microbial source attribution, resistome characterization, environmental monitoring, and contamination traceability. Integrating sequencing-guided diagnostics with laboratory traceability systems and CAPA-based quality management may shift biosafety practices from reactive contamination control toward proactive predictive biosurveillance. The proposed framework may strengthen contamination prevention, improve manufacturing reproducibility, support regulatory compliance, and enhance the reliability of stem cell processing and regenerative medicine applications. Future studies are needed to standardize sequencing-guided biosafety workflows and evaluate their implementation in academic, research, and clinical-grade stem cell manufacturing laboratories.
-
7. Coarse-graining analysis for non-invasive, label-free, and quantitative evaluation of undulating motion in cultured oral mucosa epithelial cell sheets.
PMID:日期:2026-09-02Cultured oral mucosa epithelial cell sheets (COMECS) represent a promising therapeutic approach for epithelial repair, such as corneal reconstruction or esophageal mucosa defects; however, current quality assessment methods are largely invasive and destructive. Although optical flow (OF)-based analysis has shown promise in evaluating keratinocyte motility, its sensitivity decreases under confluent conditions. A novel coarse-graining (CG) analysis combined with OF is introduced as a candidate non-invasive, label-free imaging parameter to quantitatively evaluate the characteristic undulating motion patterns (local directional synchrony of cell motion) of mature COMECS and to provide a potential basis for future quality assessment. COMECS were manufactured from passage 2 (p2) and passage 5 (p5) oral keratinocytes using standard (cultured in serum-containing medium) and sub-standard (cultured in serum-free medium) protocols. Time-lapse microscopy was conducted at multiple time points (48-, 96-, and 192-h post manufacture). The OF analysis-derived microscopic velocity fields were subjected to CG analysis to generate macroscopic velocity fields. The undulating index (UI) and mean undulating index (MUI) were calculated to quantify the directional synchrony of cellular motion. Western blotting was used to evaluate p63 and PITX1 protein expression levels to correlate the undulating motion patterns with biological markers of keratinocyte undifferentiation and oral epithelial identity. OF-based CG analysis successfully differentiated undulating motion patterns between the standard and sub-standard COMECS, with average MUI values higher in the standard COMECS ( < 0.05). Time-course analysis of p2 COMECS indicated a substantially lower average MUI at 48 h than at 96 h and 192 h, suggesting time-dependent changes in collective motion behavior. A passage-dependent comparison showed apparent temporal patterns between p2 and p5 COMECS, with p5 sheets exhibiting earlier peak undulation but reduced sustainability. The p63 and PITX1 expression levels were elevated in standard COMECS, and were associated with enhanced undulating motion patterns. This novel OF-based, CG analysis enabled non-invasive, label-free, and quantitative assessment of COMECS quality using undulating motion pattern evaluation, demonstrating both applicability and feasibility for regenerative medicine quality control applications.
-
8. Advanced therapy medicinal products in Saudi Arabia: Regulation and development.
8. 沙特阿拉伯的先进治疗药品：监管和发展PMID:日期:2026-08-24Advanced therapeutic medicinal products (ATMPs) such as gene, somatic cell, and tissue-engineered therapies have transformed modern healthcare by treating previously unmanageable genetic, oncologic, and degenerative diseases. Although regulatory and developmental frameworks for ATMPs are established in the United States, Europe, and China, limited data exist on their implementation in emerging markets such as Saudi Arabia. This review provides the first comprehensive analysis of ATMP regulation and development in Saudi Arabia while offering novel insights into the nation's evolving clinical trial landscape, regulatory infrastructure, and biomanufacturing capabilities. We conducted a narrative review of the Saudi Food and Drug Authority (SFDA) guidelines, peer-reviewed literature, and clinical trial registrations from 2010 to 2025. As of 2025, the SFDA has approved eight ATMPs, including chimeric antigen receptor T-cell therapy (CAR-T) therapies, adeno-associated virus (AAV) based vectors, and clustered regularly interspaced short palindromic repeats (CRISPR) based therapies, reflecting growing regulatory maturity and international alignment. Clinical trial activity continues to expand, with a concentration in oncology, hematology, and rare genetic diseases. National research institutions such as the King Faisal Specialist Hospital and Research Centre (KFSHRC) and King Abdullah International Medical Research Center (KAIMARC) have pioneered advances in CAR-T manufacturing, while biobanking initiatives are driving translational research. Despite ongoing challenges in workforce capacity, good manufacturing practice (GMP) infrastructure, and reimbursement mechanisms, Saudi Arabia is positioned to become a regional leader in advanced therapies through continued regulatory innovation, local manufacturing, and international collaboration.
-
9. Evaluation of the efficacy of conditioned medium derived from quality- and quantity-cultured peripheral blood mononuclear cells for erectile dysfunction.
PMID:日期:2026-08-17Neurogenic erectile dysfunction (ED) due to cavernous nerve injury (CNI) leads to irreversible apoptosis of the cavernosal smooth muscle and fibrosis. These structural changes are often refractory to conventional treatments. Serum-free quality- and quantity-cultured peripheral blood mononuclear cells (MNC-QQ), which can be manufactured within 1 week from a minimal volume of peripheral blood, were developed. MNC-QQ cells are anti-inflammatory, proangiogenic, and antifibrotic, with confirmed efficacy and safety in clinical trials for refractory limb ulcers. Conditioned medium derived from MNC-QQ cells (MNCQQ-CM) contains bioactive factors with anti-inflammatory, angiogenic, and antifibrotic properties. As a cell-free, minimally invasive therapy, it represents a promising regenerative approach. In this study, we aimed to evaluate whether MNCQQ-CM promotes cavernous tissue regeneration in a CNI-induced ED model. Corpus cavernosum smooth muscle cells (CCSMCs) isolated from murine penile tissue were assessed for proliferation and resistance to apoptosis following MNCQQ-CM treatment. Angiogenic capacity was evaluated through proliferation and tube formation assays using human umbilical vein endothelial cells (HUVECs). MNCQQ-CM composition was analyzed using enzyme-linked immunosorbent assay (ELISA). Bilateral CNI was induced in male rats, followed by intracavernosal injection of MNCQQ-CM, and subsequent evaluation of erectile function and histology. MNCQQ-CM significantly enhanced CCSMCs proliferation. Under oxidative stress, it reduced CCSMCs apoptosis. Moreover, MNCQQ-CM promoted HUVEC proliferation and tube formation, demonstrating its angiogenic potential. The presence of vascular endothelial growth factor and interleukin-10 in MNCQQ-CM was confirmed by ELISA. In CNI rats, MNCQQ-CM significantly improved erectile function and increased the smooth muscle/collagen ratio. MNCQQ-CM demonstrates therapeutic efficacy in ED through multiple mechanisms, including angiogenesis, promotion of CCSMCs proliferation, and anti-fibrotic activity. The synergistic interaction of cytokines in MNCQQ-CM contributes to ED improvement. Given its rapid and minimally invasive production process, MNCQQ-CM holds substantial promise as a novel therapeutic agent for neurogenic diseases.
-
10. Research advances in microneedle-exosome delivery systems for the treatment of multisystem diseases.
PMID:日期:2026-08-15The combined application of microneedles (MNs) and exosomes represents a significant research direction in the fields of targeted drug delivery and regenerative medicine. Their synergistic and complementary effects not only address key technical challenges associated with exosome delivery-such as low delivery efficiency and limited tissue penetration-but also endow MNs with capabilities for targeted therapy and precise diagnostics, thereby demonstrating substantial advantages in the diagnosis and treatment of multisystem diseases. This review summarizes recent advances in MN-exosome delivery systems across dermatological, cardiovascular and cerebrovascular, and musculoskeletal diseases, as well as tumor diagnosis and therapy, ocular surface disorders, and oral diseases. It focuses on the fabrication strategies, mechanisms of action, and therapeutic efficacy of various MN-based exosome delivery systems. Furthermore, it proposes research perspectives and potential solutions for diseases that respond poorly to conventional diagnostic and therapeutic approaches, providing a reference for the future development and clinical translation of MN-exosome systems.