Cytotherapy最新文献

{"title":"Aims and Scope","authors":"","doi":"10.1016/S1465-3249(25)00767-4","DOIUrl":"10.1016/S1465-3249(25)00767-4","url":null,"abstract":"","PeriodicalId":50597,"journal":{"name":"Cytotherapy","volume":"27 8","pages":"Page A1"},"PeriodicalIF":3.7,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144712020","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":"Development of a cell therapy set prototype for autologous iPS cells.","authors":"Yoshiki Nakashima, Masayoshi Tsukahara","doi":"10.1016/j.jcyt.2025.07.004","DOIUrl":"https://doi.org/10.1016/j.jcyt.2025.07.004","url":null,"abstract":"<p><strong>Background: </strong>Cell therapy using differentiated cells with less immune rejection of the patient's own cells can be realized by generating therapeutic cells from induced pluripotent stem cells (iPSCs). Current methods to produce iPSCs and differentiated cells in cell culture and processing facilities under GMP control typically involve 5-6 people working in one room. This process is suitable for large-scale production, but not for custom manufacturing of autologous iPSCs. A cell manufacturing process suitable for the production of autologous iPSCs can be implemented by simplifying aseptic operations, using small cell culture bags to enable small batch production, and providing a cell processing platform that integrates successive cell processing steps by building a connected loop of small cell culture bags.</p><p><strong>Objective: </strong>We are developing a closed culture system to produce therapeutic cells using iPSCs derived from the patient's own cells. Cell Therapy Applications for Autologous iPSCs is a closed culture kit with 10 culture ports (small cell culture bags with many connecting tubes for cell processing) for each culture step.</p><p><strong>Study design: </strong>Cells are moved from one culture port to the next at each step of the process. We initially designed our own culture port, which is a cell culture site in the cell therapy kit. Manufacturing was outsourced to CellBios (India). The ports were designed according to a series of 10 linked steps as follows: vector infection (2 hours), vector dilution, iPSC establishment (14 days), iPSC proliferation 1 (7 days), iPSC proliferation 2 (7 days), differentiation inducing solution A (0-10 days), differentiation inducing solution B (0-10 days), differentiation inducing solution C (0-10 days) and final formulation process of the cell product.</p><p><strong>Results: </strong>During iPSC derivation and differentiation induction, cells are attached to atelocollagen beads so that the cells and beads can move between culture processes without cell detachment. We conducted a pilot study to determine the effect of the beads on iPSC differentiation. In the pilot study, we first established iPSCs on atelocollagen beads using Peripheral Blood Mononuclear Cells (PBMCs) and induced the differentiation of different cells (cardiomyocytes, pancreatic progenitor cells, and dopaminergic neurons). Marker expression of the differentiated cells was evaluated.</p><p><strong>Conclusion: </strong>A series of processes were reproduced in a closed culture system to study cell characteristics.</p>","PeriodicalId":50597,"journal":{"name":"Cytotherapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144977317","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":"Cytokine release syndrome risk model with T-cell engaging therapies.","authors":"Pénélope Lafeuille, William A Blumentals, Claire Brulle-Wohlhueter, Weixi Chen, Chao Sang, Sydney Manning, Silvy Saltzman, Jan Canvin, Susan Richards, Cris Kamperschroer, Giovanni Abbadessa, Bhargav Koduru, Aniketh Talwai, Caroline Der-Nigoghossian, Yahav Itzkovich, Rahul Jain, Tanmay Jain, Jacob Aptekar, Stephan A Grupp","doi":"10.1016/j.jcyt.2025.07.002","DOIUrl":"https://doi.org/10.1016/j.jcyt.2025.07.002","url":null,"abstract":"<p><strong>Background: </strong>Cytokine release syndrome (CRS) is an adverse event associated with T-cell engaging (TCE) immuno-oncology therapies such as chimeric antigen receptor T cells (CAR-T), bispecific TCE antibodies and dual-affinity retargeting proteins.</p><p><strong>Objective: </strong>To develop a model to predict the preinfusion risk of CRS grade ≥2 for patients with solid tumors and hematologic malignancies such as acute lymphoblastic leukemia (ALL) and non-Hodgkin lymphoma (NHL) treated with TCE bispecific antibodies.</p><p><strong>Study design: </strong>A TCE dataset including clinical trials from 2014 to 2019 evaluating non-CAR-T TCE therapies was sourced from the Medidata Enterprise Data Store, an anonymized data repository from completed clinical trials. The outcome of interest was the first CRS grade ≥2 occurring within 10 days of TCE therapy. Risk factors for CRS grade ≥2 were identified from the literature and preliminary data analysis. Features were measured prior to or at the first TCE treatment. Patients were included in the analysis dataset if they had a data element fill rate of >70% for the key features. Features were pruned by assessing multicollinearity across features. Logistic regression and tree-based models were trained. Across 100 iterations with different train-test splits, the average area under the receiver-operator characteristic (AUROC) curve was calculated for each model type.</p><p><strong>Results: </strong>A total of 715 patients (115 CRS grade ≥2 and 600 CRS grade <2) were included in the analysis; most patients had ALL (81%) and 19% had solid tumors or NHL. Patients who developed CRS grade ≥2 had a higher incidence of prior infections (38% versus 28%; P = 0.03) and a higher first dose of TCE therapy (P < 0.001). The best model to predict CRS grade ≥2 had a mean AUROC of 0.69 (95% confidence interval 0.66-0.72) on the test set. When patients were ranked based on their predicted probability of getting CRS grade ≥2 and divided into quartiles based on predicted CRS grade ≥2 risk (very low, low, high, very high), the very high-risk quartile developed CRS grade ≥2 at 5.9 times the rate (38.10% [interquartile range: 33.33-43.54]) compared to the very-low risk quartile (6.45% [3.44-8.82]; the sample average was 12.96% [9.25-24.07]). Compared to patients with very low CRS grade ≥2 risk, patients with very high CRS grade ≥2 risk had ALL as a disease type (99% versus 67%, P < 0.001), received a higher TCE dose (1.00 versus 0.61, P < 0.001), had a higher rate of prior infections (49% versus 12%, P < 0.001) and a higher serum creatinine (0.60 versus 0.32, P < 0.001).</p><p><strong>Conclusions: </strong>Using the CRS grade ≥2 risk model, it was possible to stratify patients by risk categories. CRS grade ≥2 risk stratification may facilitate patient selection for TCE therapy and tailored pretreatment and monitoring of CRS to maximize treatment efficacy and safety.</p>","PeriodicalId":50597,"journal":{"name":"Cytotherapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144977157","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":"Donor T-cell and myeloid chimerism is higher after cord blood transplant than with other cell sources.","authors":"Rubiya Nadaf, Helena Lee, Omima Mustafa, Denise Bonney, Oana Mirci-Danicar, Ramya Hanasoge-Nataraj, Srividhya Senthil, Claire Horgan, Alison Logan, Kay Poulton, Robert Wynn","doi":"10.1016/j.jcyt.2025.07.003","DOIUrl":"https://doi.org/10.1016/j.jcyt.2025.07.003","url":null,"abstract":"<p><p>Differences in multi-lineage and long-term donor chimerism after hematopoietic cell transplantation (HCT) from different cell sources are not well characterized, yet such information is crucial for understanding the distinct clinical utilities of each graft type. We analyzed donor chimerism outcomes in 472 pediatric allogeneic HCT recipients (2010-2020), including 115 unrelated cord blood (CB) grafts and 357 non-CB grafts (bone marrow or mobilized peripheral blood). Primary graft failure occurred more frequently in CB recipients (4.3% vs. 0.8%, P < 0.05), but among engrafted patients, initial mean donor chimerism at neutrophil recovery was comparable (∼99% in both groups, P = 0.5). At 6- and 12-months post-transplant, mean whole blood donor chimerism was significantly higher in the CB cohort (100% vs. 93.8% at 6 months; 99.2% vs. 91% at 12 months; P < 0.0001 for both). At 24 months' follow-up, mean donor chimerism remained nearly complete in CB recipients (99.2%) but declined in non-CB recipients (75%; P < 0.0001). Lineage-specific mean chimerism values at 6 months also favored the CB group, with higher donor myeloid (CD15⁺) chimerism (100% vs. 85.2%, P = 0.001) and donor T-cell (CD3⁺) chimerism (93% vs. 70%, P < 0.0001). Statistical analyses were performed using unpaired 2-tailed t-tests for comparing mean chimerism values and Kaplan-Meier methods were used to assess the cumulative probability of sustained complete donor chimerism. CB recipients had a significantly lower risk of developing mixed chimerism over time (hazard ratio, 0.5; 95% CI, 0.3-0.6, P = 0.002). In conclusion, CB transplantation is associated with more durable and complete multi-lineage donor chimerism, a finding that likely reflects the unique immunologic capacity of CB T cells to mediate rejection of residual host hematopoietic and immune cells. This robust donor dominance is particularly evident over time and across both myeloid and lymphoid compartments, suggesting a potent and sustained graft-versus-host hematopoietic effect. These findings underscore a continued and distinct role for CB as a stem cell source-not only in reducing post-transplant relapse in malignant disease through enhanced graft-versus-leukemia activity, but also in sustaining long-term donor-derived hematopoiesis and functional graft integrity in non-malignant disorders, including metabolic diseases in which stable enzyme delivery is critical.</p>","PeriodicalId":50597,"journal":{"name":"Cytotherapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144776807","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":"Outcomes of adolescent and young adult (AYA) patients with relapsed/refractory B-cell acute lymphoblastic leukemia treated with tisagenlecleucel, real world evidence from the middle east.","authors":"Amr Hanbali, Fahad Bahkali, Farhatullah Syed, Ali Alahmari, Ahmad Alotaibi, Mansour Alfayez, Ayman Saad, Hanan Alkhaldi, Feras Alfraih, Saud Alhayli, Alfadel Alshaibani, Abdulwahab Albabtain, Abdullah Alamer, Shaykhah Alotaibi, Marwan Shaheen, Walid Rasheed, Fahad Alsharif, Naeem Chaudhri, Fahad Almohareb, Hazzaa Alzahrani, Mahmoud Aljurf, Syed Osman Ahmed, Riad El Fakih","doi":"10.1016/j.jcyt.2025.07.006","DOIUrl":"https://doi.org/10.1016/j.jcyt.2025.07.006","url":null,"abstract":"<p><strong>Background: </strong>Tisagenlecleucel (Kymriah), a CD19-directed CAR T-cell therapy, has demonstrated high efficacy in adolescents and young adults (AYA) with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL). However, data from regions such as the Middle East, Southeast Asia, and Africa remain limited. Our center, based in Saudi Arabia, has been administering Tisagenlecleucel since March 2021. In this study, we retrospectively report on both clinical outcomes and the relationship between product characteristics, toxicity profiles, and treatment response in a real-world cohort of AYA patients.</p><p><strong>Methods: </strong>We retrospectively analyzed data from 20 patients aged 14-25 years treated with Tisagenlecleucel between March 2021 and August 2024. Baseline characteristics, response rates, relapse-free survival (RFS), overall survival (OS), and toxicity data were collected. In addition, CAR T-cell product parameters, including cell composition and in-process metrics, were correlated with clinical efficacy and toxicity. Toxicities assessed included cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), and corticosteroid use.</p><p><strong>Results: </strong>The median age of the cohort was 19 years. By day 28 postinfusion, 89% of patients achieved complete remission. At a median follow-up of 12 months, the 1-year RFS and OS rates were 56% and 74%, respectively. B-cell aplasia loss occurred in 35% of patients at a median of 5 months, and 35% proceeded to allogeneic stem cell transplantation following CAR T-cell therapy. Grade III-IV CRS occurred in one patient (5%), and grade III-IV ICANS in two patients (10%). Exploratory analysis revealed associations between CAR T-cell product quality and both response and durability of remission. Additionally, steroid administration for toxicity management did not appear to compromise treatment efficacy.</p><p><strong>Conclusion: </strong>This is the first report from Saudi Arabia evaluating Tisagenlecleucel outcomes in AYA patients with relapsed/refractory B-ALL. Our data confirm favorable response and survival rates consistent with international experience. Moreover, product quality metrics and toxicity management strategies may influence treatment durability, underscoring the need for region-specific real-world evidence to inform CAR T-cell therapy optimization.</p>","PeriodicalId":50597,"journal":{"name":"Cytotherapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144790570","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":"Defining minimal criteria for peer-reviewed reporting of mesenchymal stromal cell clinical trials for autoimmune diseases.","authors":"Lindsay C Davies, Lucie Biard, Damián García-Olmo, Gary Gilkeson, Massimiliano Gnecchi, Joanne Kurtzberg, Gesine Kogler, Katarina Le Blanc, Mark W Lowdell, Yves-Marie Pers, Ling-Yun Sun, Karin Tarte, Antonio Uccelli, Fermin Sanchez-Guijo, Dominique Farge","doi":"10.1016/j.jcyt.2025.06.005","DOIUrl":"10.1016/j.jcyt.2025.06.005","url":null,"abstract":"<p><strong>Background: </strong>Mesenchymal stromal cells (MSCs) have been employed in clinical trials for their immunomodulatory capabilities, especially in the treatment of autoimmune disorders such as type 1 diabetes. In January (25-26th) 2024, the International Society of Cell and Gene Therapy (ISCT) held a two-day workshop entitled \"Cell Therapies for Autoimmune Diseases: MSCs from Biology to Clinical Application\" in Paris, France.</p><p><strong>Methods: </strong>Key opinion leaders in MSC biology, clinical and regulatory backgrounds came together with European, Asian and South American delegates to discuss the need for standardisation in the design, conduct and reporting of MSC clinical trials for autoimmune diseases.</p><p><strong>Results: </strong>The authors of this paper emphasise the need to comply with standard guidelines for protocols and reporting of trials, working towards greater transparency and reproducibility of research. Standardisation in reporting of clinical trials using MSCs for autoimmune disorders is essential so that the reader can interpret data correctly and ensure that meta-analyses are generated from comparable datasets, providing meaningful knowledge and guidelines for those working in the field.</p><p><strong>Conclusion: </strong>In this article the key considerations for the effective design and execution of a clinical trial using MSCs for autoimmune disorders, including product characterisation and key manufacturing parameters are discussed. Recommendations are made with respect to minimal criteria for data reporting, so as to move forward the development of MSC therapy and see a successful transition of these drug products to market, thereby addressing a significant unmet clinical need in autoimmunity.</p>","PeriodicalId":50597,"journal":{"name":"Cytotherapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144876629","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":"Improving lung cancer tumor-infiltrating lymphocyte (TIL) manufacturing","authors":"Pamela K Noldner ,&nbsp;Ying Zhou ,&nbsp;Liliana Lyniv ,&nbsp;Jose R Conejo-Garcia ,&nbsp;Scott Antonia ,&nbsp;Beth H Shaz","doi":"10.1016/j.jcyt.2025.07.001","DOIUrl":"10.1016/j.jcyt.2025.07.001","url":null,"abstract":"<div><h3>Background</h3><div>The successful treatment of melanoma using autologous <em>in vitro</em> expanded tumor infiltrating lymphocytes (TILs) has sparked clinical trials for the assessment of TIL efficacy against other cancers, including non-small cell lung cancer (NSCLC). This rise in clinical applications of TILs has increased the need for improved, more streamlined and cost-effective manufacturing protocols. The aim of this study was to simplify and reduce the cost of traditional TIL manufacturing protocols while maintaining GMP manufacturing compliance, yields, and quality of the TIL product.</div></div><div><h3>Methods</h3><div>Resected lung tumors were cultured to expand TILs. In side-by-side experiments, we evaluated media formulations, supplementing reagents, reagent concentrations, TIL activation methods and cryopreservation protocols. The optimizations aim to reduce labor, reagent cost, culture times, and open step manipulations. The resulting TIL products were compared against TILs produced using the Moffitt Cancer Center published protocol. We compared cell yields, viabilities, phenotypes, and TIL cytotoxic activity against matched tumor organoids.</div></div><div><h3>Results</h3><div>TILs were successfully expanded from 35 fragmented tumor samples using T-cell specific media in place of RPMI, human AB serum in place of human platelet lysate and α-CD3/CD28 nanobeads in place of feeder cells for cell activation. Culture duration was reduced from 6 to 7 weeks to 4 weeks and the final product contained an average of 200e9 TILs that were predominantly of the memory phenotype and effectively killed matched tumor cells. While TIL yields and phenotypes were comparable to those produced by the Moffitt Cancer Center protocol, cytotoxicity against matched tumor cells was superior.</div></div><div><h3>Conclusion</h3><div>Traditional TIL manufacturing protocols could be optimized and streamlined into a more cost-effective process for a TIL product that is cytotoxic to tumor cells and yields quantities suitable for clinical studies.</div></div>","PeriodicalId":50597,"journal":{"name":"Cytotherapy","volume":"27 10","pages":"Pages 1240-1250"},"PeriodicalIF":3.2,"publicationDate":"2025-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144676391","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":"Aims and Scope","authors":"","doi":"10.1016/S1465-3249(25)00752-2","DOIUrl":"10.1016/S1465-3249(25)00752-2","url":null,"abstract":"","PeriodicalId":50597,"journal":{"name":"Cytotherapy","volume":"27 7","pages":"Page A1"},"PeriodicalIF":3.7,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144563358","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":"Gene therapy for sickle cell disease: recent advances, clinical trials and future directions","authors":"Josiah Ballantine,&nbsp;John F. Tisdale","doi":"10.1016/j.jcyt.2024.11.006","DOIUrl":"10.1016/j.jcyt.2024.11.006","url":null,"abstract":"<div><div>Sickle cell disease (SCD) is the most common inherited blood disorder worldwide, impacting millions and imposing severe healthcare challenges, particularly in resource-limited regions. Current treatments have variable efficacy and require lifelong adherence. Allogeneic Hematopoietic Stem Cell Transplantation can be curative but comes with significant side effects and limited donor availability limits its widespread applicability. Gene therapy, by addressing the root genetic causes, offers a revolutionary alternative. This article discusses the molecular mechanisms of SCD and β-thalassemia and highlights advancements in gene therapy, such as gene addition via lentiviral vectors and gene editing with CRISPR/Cas9 technology. Clinical trials have brought about significant progress but challenges remain, including leukemogenesis, delivery efficiency and cost. Future efforts must focus on enhancing efficiency, reducing costs, developing nongenotoxic conditioning regimens and methods for <em>in vivo</em> application.</div></div>","PeriodicalId":50597,"journal":{"name":"Cytotherapy","volume":"27 7","pages":"Pages 826-834"},"PeriodicalIF":3.7,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142900084","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":"Smart Cell Therapy: an industry perspective on macrophages as living drugs","authors":"David T. Rodgers ,&nbsp;Tatiana Novobrantseva ,&nbsp;Rita N. Barcia","doi":"10.1016/j.jcyt.2024.12.002","DOIUrl":"10.1016/j.jcyt.2024.12.002","url":null,"abstract":"<div><div>Macrophage-based cell therapies represent a cutting-edge frontier in immunotherapy, offering distinct advantages over conventional approaches like CAR-T. This review explores the potential of macrophages to orchestrate both innate and adaptive immune responses, enhancing the body's ability to combat diseases locally and systemically. Dubbed a \"Smart Cell Therapy,\" macrophages can initiate and coordinate complex immunological cascades, leveraging multiple immune system components while also performing effector functions. However, significant challenges persist in developing these therapies, including limited macrophage expansion capacity, inefficient genetic engineering, difficulties with large-scale production, and demonstrating late-stage clinical success. Despite these obstacles, ongoing research and clinical trials indicate that macrophage-based therapies hold immense potential to revolutionize treatment approaches across a spectrum of diseases, from cancer to regenerative medicine. With a focus on industry-led development, this review examines the current landscape of macrophage-based cellular therapies, discussing their promising potential and the substantial hurdles that must be overcome to realize their full therapeutic value.</div></div>","PeriodicalId":50597,"journal":{"name":"Cytotherapy","volume":"27 7","pages":"Pages 849-863"},"PeriodicalIF":3.7,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144563224","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}