Cytotherapy最新文献

{"title":"Aims and Scope","authors":"","doi":"10.1016/S1465-3249(25)00818-7","DOIUrl":"10.1016/S1465-3249(25)00818-7","url":null,"abstract":"","PeriodicalId":50597,"journal":{"name":"Cytotherapy","volume":"27 10","pages":"Page A1"},"PeriodicalIF":3.2,"publicationDate":"2025-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145050678","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Subscription information","authors":"","doi":"10.1016/S1465-3249(25)00821-7","DOIUrl":"10.1016/S1465-3249(25)00821-7","url":null,"abstract":"","PeriodicalId":50597,"journal":{"name":"Cytotherapy","volume":"27 10","pages":"Page A5"},"PeriodicalIF":3.2,"publicationDate":"2025-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145050681","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cryopreservation of implantable human skeletal muscle-derived cell-microcarrier combinations for use in clinical regenerative medicine.","authors":"Chara Simitzi, Juzheng Zhang, Rainer Marksteiner, Barry Fuller, Richard M Day","doi":"10.1016/j.jcyt.2025.09.005","DOIUrl":"https://doi.org/10.1016/j.jcyt.2025.09.005","url":null,"abstract":"<p><strong>Background aims: </strong>Regenerative medicine therapies include tissue-engineered constructs to restore tissue and organ function. Among the different approaches, implantable polymeric microcarriers have been proposed for delivery of anchorage-dependent cells to target tissue locations. Cell-microcarrier combinations produced as fresh advanced therapy medicinal products face significant challenges in terms of manufacturing and time distribution. In the current study, we have explored the feasibility of cryopreservation for human skeletal muscle-derived cells (SMDC)-implantable microcarrier combinations.</p><p><strong>Methods: </strong>Existing and novel cryoprotectant formulations combined with slow cooling were investigated, along with rapid and slow thawing regimens.</p><p><strong>Results: </strong>Under specific conditions after cryopreservation and thawing, most SMDC cells were viable and remained attached to the microcarriers. Furthermore, the capacity of human SMDCs to differentiate into myotubes was unaffected. The cryopreservation process did not alter the physico-mechanical properties of the microcarriers enabling them to retain their primary function of an implantable cell substrate.</p><p><strong>Conclusions: </strong>Overall, these findings pave the way to use cold-chain product supply for future clinical studies with the implantable cell-microcarrier technology.</p>","PeriodicalId":50597,"journal":{"name":"Cytotherapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145253090","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Long-term cryopreservation of hematopoietic stem and progenitor cells: functional viability beyond two decades.","authors":"Rebecca Axelsson-Robertson, Thomas Poiret, Lyda M Osorio, Michael Uhlin","doi":"10.1016/j.jcyt.2025.09.001","DOIUrl":"https://doi.org/10.1016/j.jcyt.2025.09.001","url":null,"abstract":"<p><p>Due to their ability to differentiate into the full diversity of blood cells, CD34+ hematopoietic stem and progenitor cells (HSPC) can be used to treat a variety of diseases. In autologous transplantation CD34+HSPC are harvested when patients are in remission, cryopreserved and later reinfused after therapy. In many cases the harvested cells are cryopreserved for several years. It is unclear how extended, long-term cryostorage affects the quality of CD34+HSPC. This study assessed quality markers in a unique library of 30 CD34+HSPC grafts, cryopreserved for up to 34 years. The samples were divided into 3 groups (<10y, 10-19y and ≥20y) based on their time in cryostorage. Viability indicators, phenotypic as well as functional markers were evaluated. Our results concluded that CD34+HSPC cryostored grafts were resilient to time. No quality marker, except production of selected cytokines, differed between the first and second decade of preservation. After more than two decades of preservation the viability of total leukocytes (CD45+7-AAD-) (P = 0.041), HSPC (CD34+7-AAD-) (P = 0.015), the functionality measured by CFU (P = 0.005) and Th1 and Th2 cytokine production of the grafts were significantly decreased. Despite this, grafts preserved more than twenty years, retained some viability and some ability to form colonies. In addition, most of the live cells retained enzymatic function and capacity to produce cytokines. In conclusion, although more cells die with time, the cells surviving cryopreservation retain some functional capacity after more than two decades of storage. Based on this study, it is hard to identify a time-limit for cryostorage.</p>","PeriodicalId":50597,"journal":{"name":"Cytotherapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145276486","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of pre- and post-thaw processing on recovery and fitness of cord blood mononuclear cells as starting material for cell therapy.","authors":"Laurie Coutu-Godbout, Josée Perreault, Diane Fournier, Éric Boilard, Patrick Trépanier","doi":"10.1016/j.jcyt.2025.09.003","DOIUrl":"https://doi.org/10.1016/j.jcyt.2025.09.003","url":null,"abstract":"<p><strong>Background: </strong>Cord blood units (CBUs) are a well-established source for hematopoietic stem cell transplantation, but key challenges such as post-thaw recovery and functional integrity remain to be addressed for their broader use in emerging cell therapy applications.This study evaluates the impact of pre-cryopreservation mononuclear cell isolation and compares four post-thaw processing methods - Wash-only, Density Gradient, Beads (CD15/CD235 depletion), and EasySep™ Direct Human PBMC Isolation Kit - on CBMC recovery, purity, and functional fitness.</p><p><strong>Study design and methods: </strong>CBUs were processed either by standard volume reduction or by mononuclear cell isolation prior to cryopreservation. Colony-forming Units, metabolic activity, and Live, Apoptosis-Negative (LAN) assays were performed pre-freeze and post-thaw to compare cell fitness across these two pre-cryopreservation approaches. Separately, post-thaw CBMCs were isolated from volume-reduced CBUs using the four different methods, and outcomes were assessed by flow cytometry for immune subset recovery on day 0, as well as T cell proliferation and cell fitness with the apoptosis assay after five days of culture.</p><p><strong>Results: </strong>Pre-cryopreservation mononuclear cell isolation did not improve post-thaw CBMC recovery or function compared to standard volume-reduced units. Beads and PBMC Isolation Kit achieved the highest depletion, while Wash-Only retained the lowest levels of purity but the highest CBMC yield. PBMC Isolation Kit - processed samples showed the highest percentage of viable LAN cells on Day 0, whereas the Beads method best preserved viability over five days of stimulation. The LAN assay, previously validated only for fresh cells, was successfully applied to post-thaw CBUs. Notably, PBMC Isolation Kit significantly depleted CD14+ cells, which correlated with reduced T cell proliferation.</p><p><strong>Discussion: </strong>These findings highlight trade-offs between purity, recovery, and functional outcomes in CBU processing. The choice of method should be application specific, particularly when antigen presentation or long-term viability is required. This study provides a framework for optimizing post-thaw processing to enhance CBU suitability for cell therapy.</p>","PeriodicalId":50597,"journal":{"name":"Cytotherapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145201975","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Automated vertical wheel bioreactor integrated with process analytics for T-cell manufacturing.","authors":"Bryan Wang, Bharat Kanwar, Annie C Bowles-Welch, Walker Byrnes, Paloma Casteleiro Costa, Caroline Filan, Reginald Tran, Theresa Kotanchek, Francisco Robles, Krishnendu Roy, Stephen Balakirsky","doi":"10.1016/j.jcyt.2025.08.007","DOIUrl":"https://doi.org/10.1016/j.jcyt.2025.08.007","url":null,"abstract":"<p><strong>Background aims: </strong>Biomanufacturing of cell therapies involves highly complex and labor-intensive processes, where process parameters and biological variabilities can significantly influence product quality, reproducibility and therapeutic efficacy. Here, we developed a vertical wheel-based bioreactor platform with automated controls and in-line process analytical technologies (PAT) to demonstrate successful closed-system T cell biomanufacturing.</p><p><strong>Methods: </strong>By identifying the critical process parameters (CPP), a process development strategy was optimized for expanding primary human unmodified and chimeric antigen receptor (CAR) T cells using multiple activation systems, including degradable microscaffolds.</p><p><strong>Results: </strong>Spent media analysis combined with symbolic regression identified CPPs, which were validated through small-scale experiments and large-scale expansions in the bioreactor platform. Closed-loop automation with analytics such as real-time imaging also was integrated into the bioreactor platform for continuous monitoring and process control.</p><p><strong>Conclusions: </strong>This integrated bioreactor platform provides a proof-of-concept design for multiplexed PAT integration, process optimization and feedback-controlled intelligent automation to enable discovery, monitoring and control of critical quality attributes and critical process parameters for cell therapy manufacturing.</p>","PeriodicalId":50597,"journal":{"name":"Cytotherapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145202036","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimizing cryopreservation in hematopoietic cell therapy: the case for evaluating DMSO concentration alongside freezing methodology.","authors":"Rongmei Wang","doi":"10.1016/j.jcyt.2025.08.009","DOIUrl":"https://doi.org/10.1016/j.jcyt.2025.08.009","url":null,"abstract":"","PeriodicalId":50597,"journal":{"name":"Cytotherapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145180119","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Universities can do more to prepare the biomedical workforce for the cell-, tissue- and gene-manufacturing industry.","authors":"Ashley How, Min Thu Ta, Duc Tuan Thanh Phan, Andy Tay","doi":"10.1016/j.jcyt.2025.08.004","DOIUrl":"https://doi.org/10.1016/j.jcyt.2025.08.004","url":null,"abstract":"<p><strong>Background and aims: </strong>Precision medicine is poised to revolutionize the treatment of complex diseases, with cell, tissue and gene therapy products (CTGTP) emerging as a major driver of innovation. As industry demand for skilled professionals grows, academic institutions must adapt to equip graduates with the necessary expertise. This study examines the undergraduate curricula and internship programs of top English-speaking universities globally to assess their alignment with industry needs in the CTGTP sector.</p><p><strong>Methods: </strong>We conducted a comparative analysis of undergraduate programs in biomedical sciences, bioengineering and life sciences, identifying CTGTP-related coursework and evaluating the depth of theoretical training offered. In addition, we mapped major biomedical companies to determine the availability of internship and research opportunities, highlighting discrepancies between academic preparation and workforce requirements.</p><p><strong>Results: </strong>Our findings indicate that although some universities are trying to integrate CTGTP as a teaching component, many institutions offer limited coursework, leaving students to seek specialization through electives, special programs or postgraduate education.</p><p><strong>Conclusions: </strong>To address this bottleneck in skilled labor, we propose curriculum enhancements, stronger industry-academic partnerships and expanded practical training opportunities to better prepare graduates for careers in the cell, tissue and gene manufacturing industry.</p>","PeriodicalId":50597,"journal":{"name":"Cytotherapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145056143","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quality indicators for cell collections for immune effector cell and gene therapy: recommendations from the American Society for Apheresis.","authors":"Nicole A Aqui, Patricia A Shi, Yara A Park, Yvette C Tanhehco, Suzanne R Thibodeaux, Joseph Schwartz, Leon Su, Gaurav K Gupta, Jeffrey L Winters, Yan Yun Wu, Jennifer Schneiderman, Nour AlMozain, Saadiya Nazli, Theodros Mamo, Wen Lu, Divjot Singh Lamba, Jan C Hofmann, Hien D Liu","doi":"10.1016/j.jcyt.2025.08.006","DOIUrl":"https://doi.org/10.1016/j.jcyt.2025.08.006","url":null,"abstract":"<p><p>Immune effector cell (IEC) therapies provide increasingly important treatment options for patients with certain hematologic malignancies. Apheresis comprises a critical step, providing the starting material from which peripheral-blood derived IEC therapies are manufactured. Regulatory and accreditation bodies providing laws, regulations, guidance, and standards appropriately impose high quality goals for apheresis collection facilities, but they are often not all congruent with clinical trial requirements. Multiple efforts are underway to standardize apheresis procedures for IEC therapies. However, few publications give practical guidance on establishing quality indicators for apheresis collection facilities. Recognizing this, the American Society for Apheresis (ASFA) Clinical Applications Committee (Immune Effector Cell Therapy Subcommittee) sought to review and define the quality indicators that can be applied at each phase of the collection process. This paper is primarily focused on apheresis collection facilities in the United States (US), but general concepts may be applicable outside of the US as well. These recommendations are also endorsed by the Foundation for the Accreditation of Cellular Therapy (FACT), Association for the Advancement of Blood and Biotherapies (AABB), and International Society for Cell & Gene Therapy (ISCT).</p>","PeriodicalId":50597,"journal":{"name":"Cytotherapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145187435","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cell and gene therapy approvals in Asia: regulatory landscape, access and affordability.","authors":"William Ying Khee Hwang, Sudipto Bari, Shin Kawamata, Bryan Choi, Chaiyong Koaykul, He Huang, Pawan Gupta","doi":"10.1016/j.jcyt.2025.08.005","DOIUrl":"https://doi.org/10.1016/j.jcyt.2025.08.005","url":null,"abstract":"<p><p>Cell and gene therapies (CGTs) are revolutionizing the treatment paradigm for a range of life-threatening and rare conditions, offering curative potential where conventional therapies have fallen short. In Asia, the CGT landscape has matured significantly in recent years, driven by regulatory reforms, increased local development and a growing number of product approvals. This updated review presents a comprehensive analysis of CGT regulatory frameworks, product approvals, pricing trends and reimbursement policies across six key Asian markets: Singapore, Japan, South Korea, China, India and Thailand. Drawing upon updated data from 2023 to 2025, we examine differences in regulatory maturity, access pathways, affordability and local manufacturing capabilities. The review highlights how certain countries, such as Japan and South Korea, have successfully implemented fast-track regulatory pathways, while others, like India and China, have emphasized domestic innovation to drive down costs. Despite progress, affordability, scalability and sustainable reimbursement remain persistent challenges. By presenting an up-to-date comparative analysis and synthesizing emerging policy innovations, this article offers insights into opportunities for harmonization, equitable access and future policy planning in Asia's rapidly evolving CGT sector.</p>","PeriodicalId":50597,"journal":{"name":"Cytotherapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145187474","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}