- Research Article
- 10.1016/j.jcyt.2026.102122
Development of a proficiency testing platform for advanced therapies medicinal products (ATMPs).
- Jun 01, 2026
- Cytotherapy
- Jesús Chaparro-García + 18 more +18
Publications from 2021 to 2026
Showing 10 of 41 papers
Development of a proficiency testing platform for advanced therapies medicinal products (ATMPs).
Col-Ovo: Smartphone-based artificial intelligence for rapid counting of <i>Aedes</i> mosquito eggs under field conditions
Abstract Background OviCol has recently been proposed as a disruptive strategy for the surveillance and control of synanthropic Aedes mosquitoes, vectors of dengue, Zika, and chikungunya viruses. The approach integrates monitoring and control through ultra–low-cost ovitraps (∼0.2 USD), bioattractants, and egg inactivation using hot water. However, large-scale ovitrap surveillance generates thousands of egg substrates that require time-consuming manual counting, creating a major operational bottleneck. To address this limitation, we developed Col-Ovo, an artificial intelligence–based tool for automated counting of Aedes aegypti eggs from real field samples, together with OviLab, a digital platform for annotation, curation, and management of entomological image datasets. Methodology/Principal Findings The detection model was trained using YOLOv11m on a dataset of 275 oviposition substrates (20.5 cm strips) collected under routine operational conditions. Images were captured in situ without preprocessing and included substrates heavily stained by bioattractants such as blackstrap molasses and dry yeast ( Saccharomyces cerevisiae ), as well as sand and particulate debris, reflecting realistic field conditions. The system was designed to operate with standard smartphone images and tolerate compression artifacts produced by messaging platforms such as WhatsApp. Performance was evaluated by comparing automated egg counts with expert manual counts and with virtual-human counts conducted in OviLab using >200% image magnification. Col-Ovo achieved >95% agreement with expert counts and 88% agreement with OviLab while reducing processing time from approximately 15 minutes to <3 seconds per sample. Conclusions/Significance Col-Ovo enables rapid, scalable quantification of Ae. aegypti eggs from smartphone images, addressing a critical operational barrier in ovitrap-based surveillance. The system requires no image preprocessing or specialized hardware and is accessible through a lightweight web interface supported by an AI architecture that allows retraining for new ecological contexts or additional Aedes species. Integrated with OviLab, this platform provides a flexible digital infrastructure that can strengthen routine vector surveillance and community-level control programs across regions where Aedes mosquitoes continue to expand. Author Summary Mosquitoes that transmit dengue, Zika, and chikungunya are expanding in many parts of the world. Monitoring their populations is essential for guiding prevention and control actions. A common surveillance method uses small traps where female mosquitoes lay their eggs. By counting the eggs collected in these traps, health programs can estimate mosquito abundance and detect increases in risk. However, the eggs are extremely small: about 0.065 mm², and are usually counted manually under magnification. This process is slow, requires trained personnel, and limits how many samples can be analyzed in routine surveillance. In this study, we developed a digital tool that automatically counts mosquito eggs from photographs taken with a smartphone. The system was trained using images collected under real field conditions, including samples with stains, dirt, and other materials commonly found in mosquito traps. The tool can analyze images even when they are compressed and shared through WhatsApp. By reducing counting time from 15 minutes to only a 25 seconds, this approach can help strengthen mosquito surveillance and support faster responses to mosquito-borne disease risks.
Read moreContrasting ozone responses driven by Mediterranean ventilation and anticyclonic blocking under high-temperatures in coastal Southwestern Europe
Evaluating Repetitive Transcranial Magnetic Stimulation in Spinocerebellar Ataxia: A Meta-Analysis of Efficacy and Safety.
To evaluate the efficacy and safety of repetitive Transcranial Magnetic Stimulation (rTMS) in Spinocerebellar Ataxia (SCA) patients. We conducted a systematic review and meta-analysis of nine Randomized Controlled Trials (RCTs). Searches covered major databases (Medline, Embase, CENTRAL, etc.) and trial registries (ICTRP, ClinicalTrials.gov). We included RCTs comparing rTMS with sham stimulation on outcomes for efficacy (ataxia severity, quality of life) and safety (adverse events, tolerability). Data were extracted, bias was assessed (RoB 2), and certainty of evidence was evaluated using the GRADE approach. All included studies used sham stimulation, with follow-ups up to four weeks. Pooled analyses showed significant differences favoring rTMS immediately post-intervention for global ataxia severity (International Cooperative Ataxia Rating Scale-ICARS-: MD -4.07, low certainty; Scale for the Assessment and Rating of Ataxia-SARA-: MD-1.55, very low certainty). Moderate-certainty evidence demonstrated significant improvements in the ICARS subdomains for posture and gait (MD -1.53, p<0.00001) and limb function (MD -3.59, p<0.00001). However, no significant effect was found for speech disorders. rTMS was well-tolerated; safety assessment showed no significant difference in adverse events or dropout rates (low certainty), and no serious adverse events were reported. Evidence was insufficient to assess the quality of life or long-term effects. Low to very-low certainty evidence suggests that rTMS, compared to sham, provides slight but clinically relevant short-term improvement in motor function and global ataxia severity in SCA patients, with comparable safety profiles. Our effect estimations are derived from small, highly heterogeneous RCTs conducted predominantly in Asian cohorts with SCA3. Rigorous studies with longer follow-up are needed to confirm the sustained utility of this intervention.
Read moreAmphiphile‐Assisted Synthesis of Ruthenium Nanoparticles for Controlled Release and Enhanced Antibacterial Activity
A novel procedure for preparing Ruthenium nanoparticles (RuNPs) based on low‐molecular‐weight amphiphilic molecules and Ru(III) complexes as antibacterial agents with controlled release properties has been developed. Two hydrophobic Ru(III) complexes, Ru‐TOA and Ru‐Benza, analogs to the NAMI‐A prodrug, are encapsulated within the core of the micelles formed through the self‐assembly of these amphiphiles. The self‐assembly of amphiphile I, which contains a double polar head, results in highly water‐stable and monodispersed RuNPs incorporating both hydrophobic Ru complexes. These RuNPs exhibit hydrodynamic sizes ranging from 26.7 to 104.2 nm for NPs derived from Ru‐TOA complex, and ≈10 nm for those derived from Ru‐Benza. Compared to Ru(III) complexes, these RuNPs offer several advantages, including protection from aqueous degradation and enhanced bacterial uptake. Moreover, post‐synthesis modification of the RuNPs with molecular staples based on polyethylene glycol chains of varying lengths enables controlled Ru release, reducing the burst effect. Interestingly, these RuNPs demonstrate excellent antibacterial activity, with minimum inhibitory concentration (MIC) values of 16 mg·L−1 and minimum bactericidal concentration (MBC) values of 32 mg·L−1 against a broad range of Gram‐positive bacteria, including S. aureus, Staphylococus pseudintermedius, and Enterococcus faecalis, highlighting their potential efficacy against clinically relevant bacterial strains.
Read moreDiagnostic performance of telephone triage for nontraumatic chest pain in the emergency coordination center: a population-based study in Andalusia.
To assess the diagnostic performance of the Emergency Coordination Center (CCUE) in identifying priority one or emergent cases among calls reporting nontraumatic chest pain. This retrospective diagnostic performance study (2020-2024) analyzed a total of 248,116 calls categorized as nontraumatic chest pain, of which 97,905 included a clinical diagnosis. The assigned priority level was compared with the clinical diagnosis established by the out-of-hospital medical team, which served as the reference standard. Diagnostic performance metrics were calculated according to sociodemographic, territorial, and methodological variables. Uni- and multivariate analyses were conducted to identify factors associated with under- and overtriage. Undertriage occurred in 7.1% of cases and overtriage in 77.4%. Overall accuracy rate was 48.1%; sensitivity rate, 84.7%; and specificity rate, 40.6%. The positive predictive value was 22.6%, and the negative predictive value was 92.9%. Structured triage (GTTA23) showed lower sensitivity (78.9% vs 91.0%; P .001) but higher specificity (44.2% vs 31.6%; P .001), with a trend toward lower undertriage (6.6% vs 10.7%; P = .180) and higher overtriage (82.6% vs 61.8%; P .001) vs direct assignment. Interprovincial differences were low to moderate. In multivariate analysis, undertriage was associated with older age, home care, and nighttime calls, while female sex was protective. Overtriage was more likely among women, in public settings, and when coordination time was shorter. The diagnostic performance of the CCUE for nontraumatic chest pain shows adequate sensitivity but low specificity, with acceptable undertriage and high overtriage. Structured triage improves the balance between safety and efficacy, although differences persist according to sex, age, and care setting.
Read moreCONSENTIS - An Innovative Framework for Identity and Consent Management for EU Digital and Data Strategies
For many years now, the management of personal information and consent for access and usage remain among the top priorities and challenges in the online world. Individuals demand better control, transparency, and security over their personal data and companies need clear processes compliant with laws and regulations like GDPR, eIDAS, NIS2 etc. This paper presents CONSENTIS, a solution which offers Self-Sovereign Identity and user-centric consent management solutions aiming at empowering users with full control over their data, enabling informed consent, selective data sharing, and real-time transparency. Designed to be agnostic to existing systems, CONSENTIS ensures legal compliance and security through a continuous assessment mechanism, facilitating trust and compliance with EU regulations and strategic digital data initiatives.
Read moreLaboratory-Generated Autologous Skin Substitutes for Burn Treatment in Europe: Narrative Review, Experts’ Opinion, and Legal Considerations
Autologous skin substitutes represent a promising advancement in the treatment of burn injuries, offering personalized solutions for patients with extensive skin loss. This white paper synthesizes the current knowledge on laboratory-generated autologous skin substitutes in Europe, incorporating expert opinions and legal considerations. The white paper examines the scientific principles underlying autologous skin substitute development, including cell sourcing, bioengineering techniques, and clinical applications. The regulatory framework governing the production and use of these advanced therapies in Europe is also examined, highlighting challenges in standardization, safety, and approval pathways. The text features expert insights that offer a real-world perspective on the clinical viability and translational hurdles of autologous skin substitutes. The findings highlight the potential of autologous skin substitutes to improve burn treatment outcomes while emphasizing the need for harmonized regulations to facilitate clinical implementation. Despite technological advancements, significant challenges persist, including production costs, scalability, and long-term efficacy. Another focus of this white paper are the legal changes, which have significantly impacted the production and availability of these technologies. The review concludes that while autologous skin substitutes hold great promise, further research, regulatory refinement, and interdisciplinary collaboration are essential to optimize their integration into clinical practice.
Read moreEfficacy of deep brain stimulation in treating monogenic dystonia symptoms: protocol for a systematic review
IntroductionComplexity leads to some dystonias being considered as rare diseases with scarce synthesised evidence. Despite the deficit of scientific evidence, deep brain stimulation (DBS) is currently an effective treatment for dystonias using different brain targets, providing significant improvement of dystonic symptoms regardless of their cause. However, there is considerable variability and non-response rate due to factors such as classification, semiology, duration, aetiology and genetic cause of the disease. This protocol presents the methodology of a planned systematic review to assess the efficacy of DBS as a treatment for monogenic dystonia symptoms, a broad spectrum of pathogenic dystonias due to variants in single genes not yet explored.Methods and analysisThis protocol follows the Preferred Reporting Items for Systematic review and Meta-Analysis Protocols guidelines. With the aim to test the efficacy of DBS in monogenic dystonias, the research question in population, intervention, comparator and outcomes format will cover patients with monogenic dystonia treated with DBS with a minimum of 3 months' follow-up after surgery. The outcomes will be assessed using generic and specific scales to measure the efficacy and safety of the intervention. The search will be performed in generic and specific databases and bibliographic resources from 2000. We will include systematic reviews, randomised controlled trials and primary studies in English. In this protocol, the initial search strategy in MEDLINE is presented. Additionally, the protocol provides a description of the prospective assessment of the risk of bias in the selected studies. If studies appear homogeneous and the sample of patients is sufficiently large, a meta-analysis and a subgroup analysis are planned.Ethics and disseminationEthics committee approval is not required. The results of the review will be published through an open access journal.PROSPERO registration numberCRD42023448145
Read moreSurvey of Notified Bodies reveals very limited use of conditional certification for high-risk medical devices.
The aim was to identify the experiences of Notified Bodies (NBs) in Europe in applying restrictions or limitations to certificates for high-risk medical devices. A survey examining NB practices regarding restrictions or limitations applied to Class III and IIb implantable medical devices was conducted as part of the CORE-MD Horizon 2020 project. Thirteen NBs responded; three had issued certificates of conformity with restrictions or limitations. NBs reported challenges in collecting and providing data on conditional certification, which would likely increase their workload. Enhancing clarity of regulatory standards, improving data transparency, fostering stakeholders' collaboration, and providing targeted training are essential to ensure uniform and homogeneous application of conditional certifications across the EU.
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