Regenerative medicine最新文献_第6页

Industry updates from the field of stem cell research and regenerative medicine in August 2025. 2025年8月来自干细胞研究和再生医学领域的行业更新。

IF 3 4区医学

Regenerative medicine Pub Date : 2025-12-01 Epub Date: 2025-10-18 DOI: 10.1080/17460751.2025.2576320

Dusko Ilic, Mirjana Liovic

引用次数: 0

Reimbursement routes and past practices for advanced therapy medicinal products in the Netherlands. 荷兰先进治疗药品的报销路线和过去的做法。

IF 3 4区医学

Regenerative medicine Pub Date : 2025-12-01 DOI: 10.1080/17460751.2025.2594314

Jurriaan Gort, Christine C van Hattem, Floris Logman, Geert W J Frederix, Lotty Hooft, Lourens T Bloem, Renske M T Ten Ham

{"title":"Reimbursement routes and past practices for advanced therapy medicinal products in the Netherlands.","authors":"Jurriaan Gort, Christine C van Hattem, Floris Logman, Geert W J Frederix, Lotty Hooft, Lourens T Bloem, Renske M T Ten Ham","doi":"10.1080/17460751.2025.2594314","DOIUrl":"10.1080/17460751.2025.2594314","url":null,"abstract":"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.","PeriodicalId":21043,"journal":{"name":"Regenerative medicine","volume":" ","pages":"689-706"},"PeriodicalIF":3.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12915773/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145649252","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Biomaterial platforms in cardiovascular regenerative medicine - challenges and future perspectives. 心血管再生医学中的生物材料平台——挑战与未来展望。

IF 2.6 4区医学

Regenerative medicine Pub Date : 2025-12-01 Epub Date: 2025-12-11 DOI: 10.1080/17460751.2025.2601482

Quan Duy Vo

引用次数: 0

Smart hydrogels for tissue engineering and regenerative medicine: how far have we come. 用于组织工程和再生医学的智能水凝胶：我们已经走了多远？

IF 2.6 4区医学

Regenerative medicine Pub Date : 2025-11-01 Epub Date: 2025-11-07 DOI: 10.1080/17460751.2025.2583707

Jan C Kwan, Sangeeth Pillai, Jose G Munguia-Lopez, Joseph M Kinsella, Simon D Tran

{"title":"Smart hydrogels for tissue engineering and regenerative medicine: how far have we come.","authors":"Jan C Kwan, Sangeeth Pillai, Jose G Munguia-Lopez, Joseph M Kinsella, Simon D Tran","doi":"10.1080/17460751.2025.2583707","DOIUrl":"10.1080/17460751.2025.2583707","url":null,"abstract":"Smart hydrogels have become precision platforms that interact with complex biological cues. We formalize a 2025 definition, materials that sense a clinically relevant cue and reproducibly execute a specified, reversible function under physiologic conditions, and introduce a unified, feature-based, three-tier framework: Responsive (open-loop cue and response), Adaptive (multi-cue or stateful), and Intelligent (closed-loop sense, decide, and act). This review captures momentum from 2020 to 2025, a period marked by clinical and innovative breakthroughs, FDA-cleared formulations, and integration of advanced technologies, including AI-assisted design, fourth-dimensional (4D) bioprinting, and biohybrid interfaces. We spotlight cutting-edge developments in programmable degradation, self-healing, and multi-stimuli responsiveness, alongside emerging hydrogel fabrication strategies such as nanoparticle (NP)-laden bioinks and in situ light-activated crosslinking. Although barriers to regulation and translation remain, cross-disciplinary efforts with a sustainability- and ethics-first mind-set are redefining these materials' capabilities. Smart hydrogels are no longer just innovative, researchers in tissue engineering and regenerative medicine are actively redefining both their clinical potential and what it means for a material to be \"smart.\"","PeriodicalId":21043,"journal":{"name":"Regenerative medicine","volume":" ","pages":"585-608"},"PeriodicalIF":2.6,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12607306/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145459797","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Regulatory challenges and opportunities in cell-based therapies: overcoming barriers to advancement and patient care. 细胞疗法的监管挑战和机遇：克服进步和患者护理的障碍。

IF 2.6 4区医学

Regenerative medicine Pub Date : 2025-11-01 Epub Date: 2025-10-28 DOI: 10.1080/17460751.2025.2580888

Pankaj Musyuni, Bharti Mangla, Shamama Javed, Pankaj Kumar, Waquar Ahsan

{"title":"Regulatory challenges and opportunities in cell-based therapies: overcoming barriers to advancement and patient care.","authors":"Pankaj Musyuni, Bharti Mangla, Shamama Javed, Pankaj Kumar, Waquar Ahsan","doi":"10.1080/17460751.2025.2580888","DOIUrl":"10.1080/17460751.2025.2580888","url":null,"abstract":"Cell-based therapies have emerged as a promising frontier in regenerative medicine, offering potential treatments for various degenerative, autoimmune, and genetic disorders. However, their clinical translation is accompanied by complex ethical and regulatory challenges that must be addressed to ensure patient safety, equitable access, and scientific integrity. This review explores the intricate landscape of global regulatory frameworks governing cell-based therapies, highlighting key obstacles such as inconsistent international guidelines, prolonged approval timelines, and ethical considerations. The lack of regulatory harmonization often impedes innovation and delays the availability of advanced treatments to patients in need. In addition, stringent requirements can pose barriers for emerging biotech start-ups, limiting competition and technological advancements. Despite these challenges, regulatory frameworks also present opportunities to foster innovation, enhance patient safety, and streamline drug approval process. Collaborative efforts between policymakers, regulatory bodies, industry leaders, and research institutions are crucial to developing standardized yet adaptable guidelines that accommodate scientific progress while maintaining stringent safety protocols. By fostering a regulatory ecosystem that encourages innovation without compromising safety, stakeholders can unlock the potential of cell-based therapies, paving the way for their widespread adoption and integration into clinical practice.","PeriodicalId":21043,"journal":{"name":"Regenerative medicine","volume":" ","pages":"609-624"},"PeriodicalIF":2.6,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12607302/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145392589","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The feasibility of 3D bioprinting for bone regeneration: key challenges and future directions. 3D生物打印用于骨再生的可行性：主要挑战和未来方向。

IF 3 4区医学

Regenerative medicine Pub Date : 2025-11-01 Epub Date: 2025-10-12 DOI: 10.1080/17460751.2025.2572218

Thiago Domingues Stocco, Rafael Prado de Carvalho, Hugo Cesar Oliveira Silva, Taynara Soares de Melo Sousa

{"title":"The feasibility of 3D bioprinting for bone regeneration: key challenges and future directions.","authors":"Thiago Domingues Stocco, Rafael Prado de Carvalho, Hugo Cesar Oliveira Silva, Taynara Soares de Melo Sousa","doi":"10.1080/17460751.2025.2572218","DOIUrl":"10.1080/17460751.2025.2572218","url":null,"abstract":"Three-dimensional (3D) bioprinting has emerged as a promising biofabrication strategy for bone regeneration, offering unprecedented control over the spatial distribution of cells, biomaterials, and bioactive cues. By enabling the production of anatomically customized grafts with microarchitectural complexity and biological functionality, bioprinting holds potential to overcome limitations associated with autografts, allografts, and synthetic bone substitutes. This review provides a comprehensive synthesis of recent advances in bioprinting technologies, bioink design, and recent in vitro and in vivo studies targeting bone tissue engineering. Despite encouraging preclinical outcomes, the field faces significant challenges, including limited mechanical performance, control over cellular microenvironments, lack of standardization, and trade-offs between printing resolution and scalability. Notably, no clinical trials have yet investigated bioprinted bone constructs, reflecting the translational hurdles that persist. We critically discuss these gaps and propose strategic directions. Collectively, this review underscores the feasibility of 3D bioprinting for bone regeneration while highlighting the key scientific and technical milestones needed to transition from bench to bedside.","PeriodicalId":21043,"journal":{"name":"Regenerative medicine","volume":" ","pages":"625-652"},"PeriodicalIF":3.0,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12607285/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145281073","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Regenerative therapies for upper limb functional recovery after stroke: study protocol of a randomized clinical trial. 再生疗法治疗中风后上肢功能恢复：一项随机临床试验的研究方案。

IF 2.6 4区医学

Regenerative medicine Pub Date : 2025-11-01 Epub Date: 2025-11-02 DOI: 10.1080/17460751.2025.2583705

Simin Rajaeian, Noureddin Nakhostin Ansari, Ramin Rahimnia, Mohammad Hossein Pourgharib Shahi, Shima Ghannadi, Maryam Ganjalikhani, Javad Verdi

{"title":"Regenerative therapies for upper limb functional recovery after stroke: study protocol of a randomized clinical trial.","authors":"Simin Rajaeian, Noureddin Nakhostin Ansari, Ramin Rahimnia, Mohammad Hossein Pourgharib Shahi, Shima Ghannadi, Maryam Ganjalikhani, Javad Verdi","doi":"10.1080/17460751.2025.2583705","DOIUrl":"10.1080/17460751.2025.2583705","url":null,"abstract":"Background: Stroke-related long-term disability is primarily due to impaired motor function. Rehabilitation efforts have traditionally focused on central strategies while ignoring the affected muscles. Regenerative medicine approaches have emerged as a promising option for treating various conditions, including muscular disorders. The present study aims to compare the effects of intramuscular injections of mesenchymal stromal cells (MSCs) and Platelet-rich plasma (PRP) on motor recovery in poststroke survivors.Methods: A single-blind, randomized, controlled trial will be followed. Fifteen stroke patients who meet the eligibility criteria will be randomly assigned to the cell therapy, PRP, or waiting-list control groups. Patients in each group will receive a single injection of MSCs or PRP into their affected biceps brachii muscle. Patients in the waiting list control group will receive no intervention. The outcome measures include the Modified Modified Ashworth Scale (MMAS), Brunnstrom recovery stages for the upper limb, elbow range of motion, and sonographic evaluations. All outcome measures will be assessed at baseline, 1, 2, and 3 months after injection.Conclusions: The findings of this study will provide initial supportive evidence regarding the efficacy of MSCs and PRP therapy in improving biceps brachii muscle spasticity and function in patients with chronic stroke.Trial registration: IRCT20230208057351N1.","PeriodicalId":21043,"journal":{"name":"Regenerative medicine","volume":" ","pages":"565-571"},"PeriodicalIF":2.6,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12607294/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145432186","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A systematic review of CRISPR applications in demyelinating peripheral nervous system disorders. CRISPR在脱髓鞘性周围神经系统疾病中的应用综述。

IF 3 4区医学

Regenerative medicine Pub Date : 2025-11-01 Epub Date: 2025-10-17 DOI: 10.1080/17460751.2025.2574198

Aliakbar Mariki, Kristi Anne Kohlmeier, Seyed Mohammad Mousavi, Mohammad Shabani

{"title":"A systematic review of CRISPR applications in demyelinating peripheral nervous system disorders.","authors":"Aliakbar Mariki, Kristi Anne Kohlmeier, Seyed Mohammad Mousavi, Mohammad Shabani","doi":"10.1080/17460751.2025.2574198","DOIUrl":"10.1080/17460751.2025.2574198","url":null,"abstract":"Aim: This review evaluates CRISPR-based strategies for myelin regeneration in peripheral demyelinating disorders, with a focus on Guillain - Barré syndrome (GBS) and Charcot - Marie - Tooth disease type 1A (CMT1A). It aims to identify current therapeutic approaches, delivery systems, and gaps in the literature.Materials & methods: A systematic literature search was conducted across PubMed, Scopus, Web of Science, and Google Scholar for studies published from 2010 onward, following PRISMA guidelines. Study quality was assessed using OHAT and SYRCLE tools, and 14 articles met the inclusion criteria.Results: In GBS, CRISPR interventions primarily targeted antiviral immune regulation (AXL, IFI6, IFNL2), inhibition of viral entry mechanisms (Integrin αvβ5, SPCS1), and Schwann cell repair. In CMT1A, therapeutic approaches focused on correcting PMP22 overexpression. Lentiviral transduction was the most frequently used delivery method, with no major adverse effects reported. However, most studies were in vitro, and only two were in vivo, highlighting the need for further validation in animal models.Conclusions: CRISPR technology shows considerable potential for addressing peripheral nerve demyelination through precise genetic modifications that may enhance Schwann cell function and support myelin repair. Nevertheless, the field remains at an early discovery stage, with no near-term clinical applicability demonstrated.","PeriodicalId":21043,"journal":{"name":"Regenerative medicine","volume":" ","pages":"653-662"},"PeriodicalIF":3.0,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12607297/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145313512","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Results from the SCIENCE and Danish ASC trials using allogeneic mesenchymal stromal cells to treat ischemic heart failure patients. 来自SCIENCE和丹麦ASC试验的结果，使用同种异体间充质基质细胞治疗缺血性心力衰竭患者。

IF 2.6 4区医学

Regenerative medicine Pub Date : 2025-11-01 Epub Date: 2025-10-14 DOI: 10.1080/17460751.2025.2574194

Nadia Chaaban, Jens Kastrup, Abbas Ali Qayyum

{"title":"Results from the SCIENCE and Danish ASC trials using allogeneic mesenchymal stromal cells to treat ischemic heart failure patients.","authors":"Nadia Chaaban, Jens Kastrup, Abbas Ali Qayyum","doi":"10.1080/17460751.2025.2574194","DOIUrl":"10.1080/17460751.2025.2574194","url":null,"abstract":"Background and aims: Allogeneic mesenchymal stromal cell (ASC) therapy is a potential treatment option in patients with ischemic heart failure (HF). We aimed to investigate the effect of allogeneic Cardiology Stem Cell Center Adipose tissue derived mesenchymal Stromal Cell product (CSCC_ASC) by joining data from the international SCIENCE and the Danish ASC trial.Methods: Data from two double-blinded placebo-controlled phase II studies including patients with same inclusion and exclusion criteria and identical endpoints were combined. Patients had left ventricular ejection fraction (LVEF) < 45% and New York Heart Association (NYHA) II-III without further treatment options.Results: Two hundred and fourteen patients were randomly assigned to receive CSCC_ASCs or placebo injections. There was no difference in baseline characteristics between groups.No significant differences from baseline to 6-month follow-up were detected between the intervention and placebo-group in left ventricular end-systolic volume, end-diastolic volume or LVEF (p = 0.973, p = 0.601, p = 0.152). The 6-min walking test, NYHA-classification and quality of life score were unchanged in both groups. The difference between groups in N-terminal pro B-type natriuretic peptide and C-reactive protein at 6 months was statistically significant (p = 0.045, p = 0.021).Conclusions: Post-hoc analysis demonstrated that a single intramyocardial CSCC_ASC injection in patients with chronic ischemic no-option HF did not improve cardiac function.","PeriodicalId":21043,"journal":{"name":"Regenerative medicine","volume":" ","pages":"573-584"},"PeriodicalIF":2.6,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12607287/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145286735","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Industry updates from the field of stem cell research and regenerative medicine in July 2025. 2025年7月来自干细胞研究和再生医学领域的行业更新。

IF 2.6 4区医学

Regenerative medicine Pub Date : 2025-11-01 Epub Date: 2025-08-30 DOI: 10.1080/17460751.2025.2551422

Dusko Ilic, Mirjana Liovic

引用次数: 0