{"title":"Challenges in the processing and preservation of adipose-derived stem cell subpopulations for clinical use.","authors":"Qiuyue Peng","doi":"10.1080/17460751.2024.2442843","DOIUrl":"https://doi.org/10.1080/17460751.2024.2442843","url":null,"abstract":"","PeriodicalId":21043,"journal":{"name":"Regenerative medicine","volume":" ","pages":"1-3"},"PeriodicalIF":2.4,"publicationDate":"2024-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142865206","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Klaus Hoeyer, Anne Sofie Borsch, Kim Bak Jensen, Agnete Kirkeby, Casper Steenholdt, Sarah Wadmann
{"title":"Risk-based pricing models and the role they might play in patients' access to new stem cell therapies.","authors":"Klaus Hoeyer, Anne Sofie Borsch, Kim Bak Jensen, Agnete Kirkeby, Casper Steenholdt, Sarah Wadmann","doi":"10.1080/17460751.2024.2441642","DOIUrl":"https://doi.org/10.1080/17460751.2024.2441642","url":null,"abstract":"<p><p>Stem cell research is currently undergoing a promising transformation from primarily basic research to increasing emphasis on translation and clinical trials. To reach patients, however, stem cell treatments need to be not only technically but also economically viable. In this commentry we present insights into emerging pricing models that may help ensure access to advanced and expensive treatments like stem cell therapies. Further, we present some reflections on the practical and ethical challenges that these models involve. We provide this information to allow the field of translational stem cell research to think ahead and to raise awareness of the outstanding social and ethical issues.</p>","PeriodicalId":21043,"journal":{"name":"Regenerative medicine","volume":" ","pages":"1-5"},"PeriodicalIF":2.4,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142847543","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Extracellular vesicles as standard-of-care therapy: will fast-tracking the regulatory processes help achieve the goal?","authors":"Vaijayanti Kale","doi":"10.1080/17460751.2024.2442847","DOIUrl":"https://doi.org/10.1080/17460751.2024.2442847","url":null,"abstract":"<p><p>Extracellular Vesicles (EVs) became a focus of clinical research when experimental and pre-clinical studies showed that they mimic their parent cells' regenerative and therapeutic effects and their cargo carries disease-specific diagnostic and prognostic biomarkers. Since the publication of data forms an endpoint of the study, this review specifically focused on the <i>published clinical trials</i> done with EVs. For brevity, this review was restricted to the last 10 years. Unexpectedly, the literature search showed that very few clinical trials assessing the therapeutic applications of EVs were published in this period indicating that they have not reached their desired endpoint. Conversely, most studies showed the potential of EVs present in various biofluids as a promising source of diagnostic and prognostic biomarkers for various diseases, and predictive markers to assess the effectiveness of therapy. This stark difference in the numbers could perhaps be due to the time-consuming regulatory processes involved in the clinical-grade preparation and characterization of EVs, and the determination of their safety and effective dose regimens. One wonders whether fast-tracking regulatory affairs could help accelerate the therapeutic use of EVs. This aspect needs urgent attention.</p>","PeriodicalId":21043,"journal":{"name":"Regenerative medicine","volume":" ","pages":"1-19"},"PeriodicalIF":2.4,"publicationDate":"2024-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142839087","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Artificial intelligence powers regenerative medicine into predictive realm.","authors":"Armin Garmany, Andre Terzic","doi":"10.1080/17460751.2024.2437281","DOIUrl":"https://doi.org/10.1080/17460751.2024.2437281","url":null,"abstract":"<p><p>The expanding regenerative medicine toolkit is reaching a record number of lives. There is a pressing need to enhance the precision, efficiency, and effectiveness of regenerative approaches and achieve reliable outcomes. While regenerative medicine has relied on an empiric paradigm, availability of big data along with advances in informatics and artificial intelligence offer the opportunity to inform the next generation of regenerative sciences along the discovery, translation, and application pathway. Artificial intelligence can streamline discovery and development of optimized biotherapeutics by aiding in the interpretation of readouts associated with optimal repair outcomes. In advanced biomanufacturing, artificial intelligence holds potential in ensuring quality control and assuring scalability through automated monitoring of process-critical variables mandatory for product consistency. In practice application, artificial intelligence can guide clinical trial design, patient selection, delivery strategies, and outcome assessment. As artificial intelligence transforms the regenerative horizon, caution is necessary to reduce bias, ensure generalizability, and mitigate ethical concerns with the goal of equitable access for patients and populations.</p>","PeriodicalId":21043,"journal":{"name":"Regenerative medicine","volume":" ","pages":"1-6"},"PeriodicalIF":2.4,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142807242","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Intra-articular hyaluronic acid and platelet-rich plasma as monotherapy or combination therapy in knee osteoarthritis?","authors":"Sheng-Fei Oon, Smaro Lazarakis, Gayani Mallawa, Chau Nguyen","doi":"10.1080/17460751.2024.2439221","DOIUrl":"https://doi.org/10.1080/17460751.2024.2439221","url":null,"abstract":"<p><strong>Aim: </strong>To systematically identify best current evidence on intra-articular combination therapy with hyaluronic acid (HA) and platelet-rich plasma (PRP), compared to monotherapy in knee osteoarthritis.</p><p><strong>Methods: </strong>Using the McMaster University and National Health Service five-step systematic approach, we conducted a bottom-up literature search of all existing evidence through Ovid Medline, Ovid Embase, and Cochrane (Central - Wiley) from January 2021 to June 2024.</p><p><strong>Results: </strong>Of 258 articles retrieved, we systematically narrowed best current evidence to one meta-analysis when evaluating combination therapy versus HA alone. This demonstrated superior outcomes with combination therapy against HA only at 3, 6, and 12 months on the visual acuity scale (VAS, <i>p</i> < 0.001), and with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 12 months in areas of stiffness and physical function (<i>p</i> < 0.001). For combination therapy versus PRP alone, one randomized controlled trial qualified as best current evidence. This demonstrated superior VAS outcomes with combination therapy compared to PRP monotherapy at 6 months (<i>p</i> < 0.02).</p><p><strong>Conclusion: </strong>Best current evidence indicates that intra-articular HA and PRP as combination therapy has superior short and long term symptom control over HA or PRP as monotherapy. Due to the extensive heterogeneity in the studies, results should be interpreted with caution.</p>","PeriodicalId":21043,"journal":{"name":"Regenerative medicine","volume":" ","pages":"1-8"},"PeriodicalIF":2.4,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142814128","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Industry updates from the field of stem cell research and regenerative medicine in September 2024.","authors":"Dusko Ilic, Mirjana Liovic","doi":"10.1080/17460751.2024.2427501","DOIUrl":"https://doi.org/10.1080/17460751.2024.2427501","url":null,"abstract":"<p><p>Latest developments in the field of stem cell research and regenerative medicine compiled from publicly available information and press releases from non-academic institutions in September 2024.</p>","PeriodicalId":21043,"journal":{"name":"Regenerative medicine","volume":" ","pages":"1-10"},"PeriodicalIF":2.4,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142639671","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Industry updates from the field of stem cell research and regenerative medicine in August 2024.","authors":"Dusko Ilic, Mirjana Liovic","doi":"10.1080/17460751.2024.2418246","DOIUrl":"https://doi.org/10.1080/17460751.2024.2418246","url":null,"abstract":"<p><p>Latest developments in the field of stem cell research and regenerative medicine compiled from publicly available information and press releases from non-academic institutions in August 2024.</p>","PeriodicalId":21043,"journal":{"name":"Regenerative medicine","volume":" ","pages":"1-7"},"PeriodicalIF":2.4,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142569351","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Regenerative medicinePub Date : 2024-11-01Epub Date: 2024-10-29DOI: 10.1080/17460751.2024.2405318
Timothy C Olsen, Jonnby S LaGuardia, David R Chen, Ryan S Lebens, Kelly X Huang, David Milek, Mark Noble, Jonathan I Leckenby
{"title":"Influencing factors and repair advancements in rodent models of peripheral nerve regeneration.","authors":"Timothy C Olsen, Jonnby S LaGuardia, David R Chen, Ryan S Lebens, Kelly X Huang, David Milek, Mark Noble, Jonathan I Leckenby","doi":"10.1080/17460751.2024.2405318","DOIUrl":"10.1080/17460751.2024.2405318","url":null,"abstract":"<p><p>Peripheral nerve injuries lead to severe functional impairments, with rodent models essential for studying regeneration. This review examines key factors affecting outcomes. Age-related declines, like reduced nerve fiber density and impaired axonal transport of vesicles, hinder recovery. Hormonal differences influence regeneration, with BDNF/trkB critical for testosterone and nerve growth factor for estrogen signaling pathways. Species and strain selection impact outcomes, with C57BL/6 mice and Sprague-Dawley rats exhibiting varying regenerative capacities. Injury models - crush for early regeneration, chronic constriction for neuropathic pain, stretch for traumatic elongation and transection for severe lacerations - provide insights into clinically relevant scenarios. Repair techniques, such as nerve grafts and conduits, show that autografts are the gold standard for gaps over 3 cm, with success influenced by graft type and diameter. Time course analysis highlights crucial early degeneration and regeneration phases within the first month, with functional recovery stabilizing by three to six months. Early intervention optimizes regeneration by reducing scar tissue formation, while later interventions focus on remyelination. Understanding these factors is vital for designing robust preclinical studies and translating research into effective clinical treatments for peripheral nerve injuries.</p>","PeriodicalId":21043,"journal":{"name":"Regenerative medicine","volume":" ","pages":"561-577"},"PeriodicalIF":2.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11633413/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142522848","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}
Regenerative medicinePub Date : 2024-11-01Epub Date: 2024-11-16DOI: 10.1080/17460751.2024.2427505
Rehma Chandaria, Philippa Rice, Daniel Baston, Finn Willingham, Jacqueline Barry
{"title":"ATMP clinical trials in the UK.","authors":"Rehma Chandaria, Philippa Rice, Daniel Baston, Finn Willingham, Jacqueline Barry","doi":"10.1080/17460751.2024.2427505","DOIUrl":"10.1080/17460751.2024.2427505","url":null,"abstract":"<p><strong>Aims: </strong>The UK advanced therapy medicinal product (ATMP) clinical trials database, produced annually by CGT Catapult, aims to assess the progress and state of the UK ATMP clinical development landscape. The aim of this article is to highlight key findings from the database and put them into context within the global landscape and various initiatives intended to attract ATMP developers to the UK.</p><p><strong>Method: </strong>A targeted search of GlobalData's clinical trial database was performed, followed by refinement so that only trials investigating products meeting ATMP definitions were included, and that each trial was only counted once in the analysis.</p><p><strong>Results: </strong>The 2023 data show that the number of ongoing ATMP clinical trials in the UK has remained approximately static, in contrast to a 10% reduction reported globally. Approximately 80% of these trials were commercially sponsored. Although most ATMP clinical trials are early phase, there is evidence indicating progression to later phase studies.</p><p><strong>Conclusion: </strong>The data indicate that the UK remains an attractive region for ATMP clinical trials. Factors including UK government investment in research, regulatory support offered by MHRA, and the Advanced Therapy Treatment Centre (ATTC) network of clinical sites, may contribute to the positive ecosystem available to developers of ATMPs.</p>","PeriodicalId":21043,"journal":{"name":"Regenerative medicine","volume":" ","pages":"541-548"},"PeriodicalIF":2.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11633392/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142644688","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}