{"title":"Industry updates in advanced therapy medicinal products and regenerative medicine - August 2026.","authors":"Dusko Ilic, Mirjana Liovic","doi":"10.1080/17460751.2026.2731198","DOIUrl":"https://doi.org/10.1080/17460751.2026.2731198","url":null,"abstract":"<p><p>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 August 2026.</p>","PeriodicalId":21043,"journal":{"name":"Regenerative medicine","volume":" ","pages":"1-19"},"PeriodicalIF":3.0,"publicationDate":"2026-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148945695","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 in advanced therapy medicinal products and regenerative medicine - July 2026.","authors":"Dusko Ilic, Mirjana Liovic","doi":"10.1080/17460751.2026.2719466","DOIUrl":"https://doi.org/10.1080/17460751.2026.2719466","url":null,"abstract":"<p><p>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 July 2026.</p>","PeriodicalId":21043,"journal":{"name":"Regenerative medicine","volume":" ","pages":"1-16"},"PeriodicalIF":3.0,"publicationDate":"2026-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148797600","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 : 2026-08-01Epub Date: 2026-09-21DOI: 10.1080/17460751.2026.2726833
Hanna de Groot, Paul J Besseling, Chris van Lieshout, Martin Teraa, Patricia Y W Dankers, Marianne C Verhaar, Renske M T Ten Ham
{"title":"Early economic evaluation of tissue engineered vascular access grafts for hemodialysis.","authors":"Hanna de Groot, Paul J Besseling, Chris van Lieshout, Martin Teraa, Patricia Y W Dankers, Marianne C Verhaar, Renske M T Ten Ham","doi":"10.1080/17460751.2026.2726833","DOIUrl":"10.1080/17460751.2026.2726833","url":null,"abstract":"<p><strong>Aims: </strong>Vascular access (VA) is essential for hemodialysis in patients with end-stage kidney disease. Expanded polytetrafluoroethylene (ePTFE) grafts are used for VA but are associated with high intervention rates. Tissue-engineered vascular grafts (TEVGs) are emerging as a promising alternative. However, performance and cost thresholds for TEVGs to become clinically and economically competitive to ePTFE grafts remain unclear. This early economic evaluation aims to quantify the clinical and economic impact TEVGs must achieve to be viable in routine hemodialysis care.</p><p><strong>Methods: </strong>The Dutch VA care pathway was mapped to construct a Markov model simulating intervention rates and costs of patients receiving an ePTFE graft or TEVG. As mature clinical-effectiveness data are not yet available, model inputs were derived from literature and expert opinion. Scenario analyses explored best-case and conservative TEVG performance estimates. Sensitivity analyses identified key cost-drivers.</p><p><strong>Result: </strong>Under interview-based performance estimates, TEVGs annually yielded 0.44 fewer interventions and cost savings of €601 per patient. Thrombectomies, PTA procedures and TEVG unit price were cost drivers.</p><p><strong>Conclusions: </strong>TEVGs could become clinically and economically competitive if they substantially reduce PTA and thrombectomy rates and are manufactured at cost-efficient unit prices. These findings provide actionable thresholds to guide TEVG development and support translation.</p>","PeriodicalId":21043,"journal":{"name":"Regenerative medicine","volume":" ","pages":"469-478"},"PeriodicalIF":3.0,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13671427/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149012459","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 : 2026-08-01Epub Date: 2026-09-27DOI: 10.1080/17460751.2026.2730229
Alexandre Asch, Daniel F Kalbermatten, Srinivas Madduri
{"title":"Clinical manufacturing of adipose-derived stem cells for therapeutic use: current technologies, quality systems and production challenges.","authors":"Alexandre Asch, Daniel F Kalbermatten, Srinivas Madduri","doi":"10.1080/17460751.2026.2730229","DOIUrl":"10.1080/17460751.2026.2730229","url":null,"abstract":"<p><strong>Introduction: </strong>This systematic review evaluated manufacturing technologies for adipose-derived stem cells (ADSCs), focusing on automation, quality control, potency, scalability, cost, and regulatory compliance.</p><p><strong>Methods: </strong>Following PRISMA guidelines, PubMed, Embase, and Web of Science were searched for English-language studies published January 2020-September 2025. Studies addressing clinical-grade ADSC manufacturing, quality control, regulatory compliance, or production economics were included; non-ADSC studies, reviews, case reports, and conference abstracts were excluded. Two reviewers qualitatively assessed methodological quality and bias. Heterogeneity precluded meta-analysis, so findings were synthesized narratively.</p><p><strong>Results: </strong>Forty-six studies were included; participant numbers were inconsistently reported, as the review focused on manufacturing processes. Automated bioreactors achieved 2- to 10-fold higher yields than flask-based approaches, with improved reproducibility and reduced contamination risk. Five validated platforms were identified. GMP production costs ranged from $15,000 to $50,000 per dose; automation offered potential reductions of 20%-40%. Key limitations included 3- to 5-fold inter-donor variability, 15%-25% batch-to-batch variation, and 5%-10% manufacturing failure rates.</p><p><strong>Conclusions: </strong>ADSC manufacturing is progressing toward scalable production, but clinical translation remains constrained by biological variability, limited potency-assay validation, high costs, and regulatory complexity. Standardization and clinically relevant potency assays are needed to improve consistency and access.</p>","PeriodicalId":21043,"journal":{"name":"Regenerative medicine","volume":" ","pages":"489-508"},"PeriodicalIF":3.0,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13671448/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149070098","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 : 2026-08-01Epub Date: 2026-10-06DOI: 10.1080/17460751.2026.2741432
Dylan Wood, Jonathan Paul, Falak Zaveri, Timothy Tiu, Ali Mostoufi, Jose Vives
{"title":"Extracorporeal shockwave therapy in musculoskeletal conditions: a narrative review.","authors":"Dylan Wood, Jonathan Paul, Falak Zaveri, Timothy Tiu, Ali Mostoufi, Jose Vives","doi":"10.1080/17460751.2026.2741432","DOIUrl":"10.1080/17460751.2026.2741432","url":null,"abstract":"<p><p>Extracorporeal shockwave therapy (ESWT) has evolved from its initial application in urologic lithotripsy into an increasingly utilized noninvasive treatment modality for musculoskeletal disorders. This narrative review summarizes the physical principles, mechanisms of action, treatment protocols, contraindications, and clinical applications of ESWT across a range of orthopedic and sports medicine conditions. Two primary forms of ESWT are discussed: focused shockwave therapy (FSWT) and radial shockwave therapy (RSWT), which differ in wave generation, tissue penetration, and energy delivery. Proposed therapeutic mechanisms include neovascularization, stimulation of collagen synthesis, modulation of inflammatory mediators, osteogenic signaling, and alteration of pain neurotransmission pathways.Current evidence demonstrates the strongest support for ESWT in chronic plantar fasciitis, calcific rotator cuff tendinopathy, greater trochanteric pain syndrome, mid-portion Achilles tendinopathy, and selected cases of fracture nonunion. In contrast, evidence for lateral epicondylitis, patellar tendinopathy, and non-calcific rotator cuff tendinopathy remains inconsistent due to significant heterogeneity in study protocols and outcome measures. ESWT is generally well tolerated, with most adverse effects being mild and transient, though rare, serious complications have been reported. Overall, ESWT represents a promising conservative and adjunctive treatment option, though further high-quality studies are needed to standardize protocols and optimize patient selection.</p>","PeriodicalId":21043,"journal":{"name":"Regenerative medicine","volume":" ","pages":"509-518"},"PeriodicalIF":3.0,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13671445/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149114113","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 : 2026-08-01Epub Date: 2026-10-10DOI: 10.1080/17460751.2026.2741431
Zahra Karimizadeh, Amirali Kalantari, Maryam Behfar, Dorna Karimizadeh, Leila Jafari, Amir Ali Hamidieh
{"title":"From oncogenesis to approval: the lentiviral gene therapy revolution in Wiskott-Aldrich syndrome.","authors":"Zahra Karimizadeh, Amirali Kalantari, Maryam Behfar, Dorna Karimizadeh, Leila Jafari, Amir Ali Hamidieh","doi":"10.1080/17460751.2026.2741431","DOIUrl":"10.1080/17460751.2026.2741431","url":null,"abstract":"<p><p>Wiskott-Aldrich syndrome (WAS) is an X-linked primary immunodeficiency caused by pathogenic variants in the WAS gene, resulting in absent or dysfunctional WAS protein (WASp) and a clinical triad of eczema, recurrent infections, and micro-thrombocytopenia. Allogeneic hematopoietic stem cell transplantation has historically represented the only curative option, but outcomes are constrained by donor availability, graft-versus-host disease, and transplant-related toxicity. Autologous gene therapy emerged as a compelling alternative. Early gammaretroviral vector trials confirmed that <i>ex vivo</i> correction of hematopoietic stem and progenitor cells could restore WASp expression and produce meaningful clinical benefit. However, insertional oncogenesis exposed an unacceptable genotoxic liability and drove the field toward self-inactivating lentiviral vectors. Clinical trials employing lentiviral platforms demonstrated durable, multi-lineage engraftment, sustained WASp expression, and robust immune reconstitution, with no reported cases of vector-related leukemia. These outcomes culminated in the FDA approval of WASKYRA (etuvetidigene autotemcel) in December 2025, establishing autologous gene therapy as a licensed standard of care for WAS patients lacking a suitable HLA-matched related donor. Next-generation precision gene-editing strategies and <i>in vivo</i> delivery platforms offer a path toward safer and more accessible correction. This review traces the full arc of WAS gene therapy, from early preclinical proof of concept through regulatory approval.</p>","PeriodicalId":21043,"journal":{"name":"Regenerative medicine","volume":" ","pages":"519-528"},"PeriodicalIF":3.0,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13671428/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149149244","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 : 2026-08-01Epub Date: 2026-09-08DOI: 10.1080/17460751.2026.2730232
Jyothi U Menon, Siddharth S Menon
{"title":"From targeted drug delivery to tissue regeneration: the evolving role of nanoparticle therapies in liver disease.","authors":"Jyothi U Menon, Siddharth S Menon","doi":"10.1080/17460751.2026.2730232","DOIUrl":"10.1080/17460751.2026.2730232","url":null,"abstract":"<p><p>Chronic liver disease (CLD) cases are rising globally, impacting people across all age groups. The broad spectrum of etiologies and the heterogeneous presentation of CLDs make it challenging to develop effective therapeutic interventions. Current treatments focus on eliminating the underlying cause (e.g. in infections), reducing inflammation or slowing or halting fibrosis progression. However, these treatments lack specificity and have limited ability to repair or regenerate the damaged tissue. Due to the liver's unique regenerative capability, it can repair tissue damage during early stages of CLD; however, this ability is severely compromised during late-stage CLD, necessitating novel treatments to promote tissue regeneration. Nanoparticle (NP)-based drug delivery systems offer a versatile platform that can address many of the challenges of current CLD treatments. Through cell-specific surface modifications and encapsulation of multiple therapeutics within a single system, NPs can be engineered to provide targeted, sequential delivery of therapeutics and growth-promoting agents to the damaged liver. They can also be used to track the treatment and tissue repair post-administration. This Special Report examines current treatment challenges in CLD, highlights NPs' potential to address these challenges and outlines future directions for their use in liver disease management and tissue regeneration.</p>","PeriodicalId":21043,"journal":{"name":"Regenerative medicine","volume":" ","pages":"479-488"},"PeriodicalIF":3.0,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13662885/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148907118","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}
{"title":"Industry updates in advanced therapy medicinal products and regenerative medicine - June 2026.","authors":"Dusko Ilic, Mirjana Liovic","doi":"10.1080/17460751.2026.2706785","DOIUrl":"https://doi.org/10.1080/17460751.2026.2706785","url":null,"abstract":"<p><p>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 June 2026.</p>","PeriodicalId":21043,"journal":{"name":"Regenerative medicine","volume":" ","pages":"1-16"},"PeriodicalIF":3.0,"publicationDate":"2026-07-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148550367","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 in advanced therapy medicinal products and regenerative medicine - May 2026.","authors":"Dusko Ilic, Mirjana Liovic","doi":"10.1080/17460751.2026.2692089","DOIUrl":"https://doi.org/10.1080/17460751.2026.2692089","url":null,"abstract":"<p><p>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 May 2026.</p>","PeriodicalId":21043,"journal":{"name":"Regenerative medicine","volume":" ","pages":"1-17"},"PeriodicalIF":3.0,"publicationDate":"2026-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148362153","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 : 2026-06-01Epub Date: 2026-04-26DOI: 10.1080/17460751.2026.2663180
Dusko Ilic, Mirjana Liovic
{"title":"Industry updates in advanced therapy medicinal products and regenerative medicine - March 2026.","authors":"Dusko Ilic, Mirjana Liovic","doi":"10.1080/17460751.2026.2663180","DOIUrl":"10.1080/17460751.2026.2663180","url":null,"abstract":"<p><p>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 March 2026.</p>","PeriodicalId":21043,"journal":{"name":"Regenerative medicine","volume":" ","pages":"379-391"},"PeriodicalIF":3.0,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147779659","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}