Regenerative medicine最新文献

The term "regenerative" now describes an extraordinarily broad range of therapies: advanced cell and gene therapies sit alongside off-the-shelf scaffolds, injectable biologics, and topical formulations. Yet there are no agreed criteria for what regenerative means. Assessment tools that do exist focus on single tissues and were never designed to compare different product types. As a result, regenerative labeling is largely self-assigned and often binary: a product is either regenerative or it is not.This manuscript proposes the Regenerative Potential Score (RPS), a conceptual framework to quantify how regenerative a product is within a specific tissue context. The RPS looks at three aspects of regeneration: how cells respond, how much new matrix forms, and whether the product integrates functionally in vivo. Each aspect is measured using two core assays. Results are converted to standardized effect sizes and combined into a single score. The framework anchors these numbers to negative controls and current best-practice treatments, so scores reflect real clinical differences rather than arbitrary thresholds. The goal is to provide a shared language that makes comparisons more transparent and pushes the field toward consensus-based testing standards.

Latest developments in the field of Advanced Therapy Medicinal Products and regenerative medicine compiled from publicly available information and press releases from non-academic institutions in November 2025.

Latest developments in the field of Advanced Therapy Medicinal Products and regenerative medicine compiled from publicly available information and press releases from non-academic institutions in December 2025.

Aims: Although research in cell-based therapy is expanding, little is known about patient experience in cell therapy trials to-date. This study explores the experience and attitudes of participants involved in the ASCOT randomized controlled trial, a long-term orthopedic study comparing different cell therapies for the treatment of knee articular cartilage defects.

Methods: The clinical and rehabilitation experience of participants, and their attitudes relating to i) patient and public involvement (PPIE) in research and ii) future research on cellular therapy and clinical trials were explored through questionnaires. To gather this information, the utility of an end-of-trial event to reengage participants was evaluated.

Results: Despite the anticipated high burden, overall trial experience was reported as highly positive. Communication and ongoing engagement between patients and both the clinical and research teams may have contributed to this. Key challenges identified for future research include the need for early and transparent communication regarding trial results, and greater support to facilitate active PPIE involvement. The end-of-trial engagement event demonstrated feasibility and value as a model to gather this important PPIE data for future studies.

Conclusions: This study highlights the importance of integrating participant perspectives to optimize trial design and delivery in future cell therapy research.

Cardiovascular diseases (CVDs) remain the leading cause of death worldwide, responsible for about 17.9 million deaths annually. Induced pluripotent stem cells (iPSCs) offer a patient-specific and ethically acceptable source for cardiac regeneration. Early applications using two-dimensional cultures or direct cell injection showed feasibility but were limited by poor retention and immaturity. Biomaterial-based approaches now provide supportive environments that enhance cell survival, alignment, and integration. iPSC - biomaterial platforms combining scaffolds, hydrogels, and engineered matrices have improved tissue organization and functional performance. However, persistent challenges such as incomplete maturation, arrhythmogenic risk, high production costs, and regulatory hurdles remain. Future progress will depend on integrating advanced biomaterials, gene editing, artificial intelligence, and scalable GMP-compliant manufacturing. By bridging stem cell biology and materials science, iPSC - biomaterial systems represent a promising path toward clinically viable cardiac regeneration.

Aim: Achieving market access for advanced therapy medicinal products (ATMPs) requires navigating national reimbursement routes. This is said to be particularly challenging for academic developers and small- and medium-sized enterprises, increasingly involved in ATMP development. We aimed to identify reimbursement routes for ATMPs in the Netherlands and assess how ATMPs obtained reimbursement.

Methods: We conducted a scoping review of legal and policy documents and identified ATMPs, granted EU-wide marketing authorization (MA) or national hospital exemption (HE) between January 2008 and March 2024, and assessed how these obtained reimbursement.

Results: The Dutch reimbursement process involves two steps: (i) obtaining entitlement and (ii) obtaining funding. Of the 27 ATMPs, since 2018, 82% (n = 14/17) of MA-ATMPs were temporarily excluded from reimbursement as they were placed in 'the lock,' requiring health technology assessments and often negotiations to obtain entitlement. All MA-ATMPs that obtained entitlement obtained funding through an additional code for funding ('add-on'). In contrast, HE-ATMPs cannot be placed in the lock and, although possible, the identified HE-ATMP was reimbursed without an add-on.

Conclusion: We constructed a roadmap of current reimbursement routes for ATMPs in the Netherlands and found that the MA-ATMPs followed a standard reimbursement route similar to non-ATMPs, whereas HE-ATMPs did not.

Despite remarkable progress in the clinical management of hepatocellular carcinoma (HCC), complications such as heterogenicity of HCC cells and characteristics of cancer stem cells (CSCs) contribute to frequent relapse and treatment resistance. Lack of proper in vitro models has limited developing novel approaches to evaluate innovative therapeutic settings to overcome these challenges. To address current limitations for mimicking cancer microenvironments; various three-dimensional (3D) platforms have been developed, such as tumoroids, patient-derived xenograft (PDX) models, microfluidics-based cancer chip devices, and bio-printed microtissues. Notably, 3D bio-printing technology has enabled researchers to produce scalable complex multicellular tissue models with accurate matrix composition and cellular organization. These microtissues provide precise platforms studying liver regeneration pathways, fibrosis reversal, and cellular responses to therapeutic interventions. This paper, a systematic literature search of databases covering publications from 2000 to 2025, uniquely highlights how these advances enable precise recapitulation of tumor heterogeneity and microenvironmental complexity, thereby offering transformative platforms for personalized drug screening and elucidating mechanisms of liver tissue repair and regeneration. We discussed current challenges and future directions for translating 3D bio-printed liver models into clinically relevant tools, potentially accelerating therapeutic advances and their potential applications in regenerative medicine in terms of personalized medicine and drug screening.

Latest developments in the field of Advanced Therapy Medicinal Products and regenerative medicine compiled from publicly available information and press releases from non-academic institutions in October 2025.

Clouston syndrome is a rare autosomal dominant form of hidrotic ectodermal dysplasia that presents significant challenges due to its multisystemic manifestations and limited therapeutic options. This review explores the functional role of stem cells in the treatment and management of Clouston syndrome, highlighting advancements in regenerative medicine and stem cell therapy. Stem cell types such as mesenchymal stem cells (MSCs), epidermal stem cells (EpSCs), and induced pluripotent stem cells (iPSCs) have shown promise in regenerating ectodermal derivatives like skin, hair, and nails. Gene-editing technologies, including Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR-Cas9), can correct pathogenic mutations in the GJB6 gene. Emerging techniques in tissue engineering and three dimensional (3D) bioprinting are also discussed, focusing on their potential to create patient-specific, bioengineered constructs. Clinical trials in related genetic disorders provide evidence for the feasibility of these approaches in improving patient outcomes. However, challenges such as immune rejection, ethical concerns, and stem cell production scalability remain barriers. Addressing these issues requires interdisciplinary collaboration, sustained funding, and targeted research. This review underscores the transformative potential of regenerative medicine. It highlights the need for continued efforts to develop curative strategies for treatment, integrating stem cell-based therapies, gene editing, and bioengineering.

Latest developments in the field of Advanced Therapy Medicinal Products and regenerative medicine compiled from publicly available information and press releases from non-academic institutions in September 2025.