An Open Label, Randomised, Controlled Clinical Trial to Asses the Safety of Endobronchial Administration of Allogneic Mesenchymal Stromal Cells in Patients With Lung Trasplant Chronic Rejection: Endosclad Study.

Lung transplantation is the only therapeutic alternative for more and more patients with respiratory diseases in their most advanced stages.
The most limiting factor to achieve long term survival si chronic lung allograft dysfunction, a multifactorial disease without an effective treatment.
The immunomodulatory capacity of mesenchymal stem cells enables them to be a potential therapeutic agent for this condition.
The objective of this study is to assess the safety of endobronchial administration of allogeneic MSCs in patients with chroniclung allograft dysfunction.

Start Date19 Sep 2023

Sponsor / Collaborator

Instituto De Investigación Sanitaria Puerta De Hierro-Segovia De Arana

100 Clinical Results associated with Instituto De Investigación Sanitaria Puerta De Hierro-Segovia De Arana

0 Patents (Medical) associated with Instituto De Investigación Sanitaria Puerta De Hierro-Segovia De Arana

Literatures (Medical) associated with Instituto De Investigación Sanitaria Puerta De Hierro-Segovia De Arana

21 Apr 2025·Cancer Research

Abstract 4542: B cells mediate antitumor immune response and predict pathological response in locally advanced NSCLC patients treated with perioperative chemoimmunotherapy (NADIM trials)

Author: Molina-Alejandre, Marta ; Insa, Amelia ; Gil-González, Ángeles ; Martinez-Marti, Alex ; Dómine, Manuel ; Nadal, Ernest ; Martínez-Toledo, Cristina ; González-Larriba, José Luis ; Reguart, Noemí ; Cruz-Bermúdez, Alberto ; Calvo, Virginia ; Cobo, Manuel ; Ponce, Santiago ; Sierra-Rodero, Belen ; Camps, Carlos ; de Castro, Javier ; Vivanco, Guillermo López ; Provencio, Mariano ; Collazo-Lorduy, Ana ; Casal, Joaquín ; Massuti, Bartomeu ; Campelo, Rosario García ; Bernabé, Reyes

Perioperative chemoimmunotherapy (ChIO) has become a paradigm shift in the treatment of patients with locally advanced non-small cell lung cancer (NSCLC), considerably increasing complete pathological response (CPR) and survival rates. The role played by B lymphocytes in the antitumor response emerges as a crucial factor in the fight against cancer, although mechanisms remain to be elucidated. Therefore, the main objective of this study is the identification of B lymphocyte-related mechanisms and biomarkers of response to perioperative chemoimmunotherapy treatment in patients with locally advanced NSCLC. For this purpose, tumor tissue B-cell receptor (BCR) repertoire, gene expression profile by bulk RNA sequencing, and qualitative localization by spatial transcriptomics have been characterized in 110 NSCLC patients receiving ChIO from NADIM and NADIM II trials (NCT03081689 and NCT03838159). Results of this work show an association between CPR and neoadjuvant treatment with a more diverse (p=0.069) and less even (p=0.030) BCR repertoire in pre-treatment tissue, which appears to be dominated by a set of more frequent clones (top 10, p=0.043). In addition, neoadjuvant chemoimmunotherapy induced overexpression of B lymphocyte-related genes in surgical tissue, mainly localized at tertiary lymphoid structures (TLSs) identified by spatial transcriptomics. Those tumors with low BCR repertoire evenness (CPR response) exhibited a different gene expression profile compared to highly even tumors (non-CPR). TLSs area and density were higher in CPR/low evenness sample compared to NCPR/high evenness; and functional T helper lymphocytes, defined as T CD4 lymphocytes colocalized with antigen presentation genes, were detected only in CPR/low evenness sample. In conclusion, tumor BCR repertoire clonality is associated to CPR after neoadjuvant ChIO. Neoadjuvant ChIO induces expression of B cell related genes in the context of TLS, being their area and functionality dependent on baseline BCR repertoire clonality.Citation Format:Belen Sierra-Rodero, Cristina Martínez-Toledo, Marta Molina-Alejandre, Ángeles Gil-González, Ernest Nadal, Alex Martinez-Marti, Bartomeu Massuti, Amelia Insa, Joaquín Casal, Javier de Castro, Rosario García Campelo, José Luis González-Larriba, Reyes Bernabé, Santiago Ponce, Manuel Dómine, Noemí Reguart, Carlos Camps, Guillermo López Vivanco, Manuel Cobo, Virginia Calvo, Ana Collazo-Lorduy, Mariano Provencio, Alberto Cruz-Bermúdez. B cells mediate antitumor immune response and predict pathological response in locally advanced NSCLC patients treated with perioperative chemoimmunotherapy (NADIM trials) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 4542.

01 Apr 2025·Enfermería Intensiva (English ed.)

Development and psychometric validation of the Behavioral Indicators of Pain Scale-Brain Injury (ESCID-DC) for pain assessment in critically ill patients with acquired brain injury, unable to self-report and with artificial airway

Article

Author: Temprano-Vázquez, Susana ; Pérez-Pérez, Teresa ; Rojas-Ballines, Carolina ; Romero de-San-Pío, Emilia ; López-López, Candelas ; Arranz-Esteban, Antonio ; Sarabia-Cobo, María Carmen ; Gil-Saaf, Isabel ; Solís-Muñoz, Montserrat ; Bragado-León, Mónica ; Castanera-Duro, Aaron ; Latorre-Marco, Ignacio ; Alonso-Crespo, David ; Frade-Mera, María Jesús ; Robleda-Font, Gemma ; Paredes-Garza, Francisco

INTRODUCTIONThe aim of this study was to develop and validate the adaptation of the behavioural indicators of pain scale (ESCID) for patients with acquired brain injury (ESCID-DC), unable to self-report and with artificial airway.METHODSMulticenter study conducted in 2 phases: scale development and evaluation of psychometric properties. Two blinded observers simultaneously assessed pain behaviours with two scales: ESCID-DC and Nociception Coma Scale-Revised version-adapted for Intubated patients (NCS-R-I). Assessments were performed at 3 time points: 5 min before, during and 15 min after the application of the painfull procedures (tracheal suction and application of pressure to the right and left nail bed) and a non-painful procedure (rubbing with gauze). On the day of measurement, the Glasgow Coma Score (GCS) and the Richmond Agitation Sedation Scale (RASS) were evaluated. A descriptive and psychometric analysis was performed.RESULTSA total of 4152 pain evaluations were performed in 346 patients, 70% men with a mean age of 56 years (SD = 16.4). The most frequent etiologies of brain damage were vascular 155 (44.8%) and traumatic 144 (41.6%). The median GCS and RASS on the day of evaluation were 8.50 (IQR = 7 to 9) and -2 (RIQ = -3 to -2) respectively. In ESCID-DC the median score was 6 (IQR = 4 to 7) during suction, 3 (RIQ = 1 to 4) for right pressure and 3 (RIQ = 1 to 5) for left pressure. During the non-painful procedure it was 0. The ESCID-DC showed a high discrimination capacity between painful and non-painful procedures (AUC > 0.83) and is sensitive to change depending on the time of application of the scale. High interobserver agreement (Kappa > 0.87), good internal consistency during procedures (α-Cronbach≥0.80) and a high correlation between the ESCID-DC and the NCS-R-I (r ≥ 0.75) were obtained.CONCLUSIONSThe results of this study demonstrate that the ESCID-DC is a valid and reliable tool for assessing pain in patients with acquired brain injury, unable to self-report and with artificial airway.

01 Apr 2025·Therapeutic Advances in Gastroenterology

Delphi consensus statement for the management of delayed post-polypectomy bleeding

Author: Tejedor-Tejada, Javier ; Mangas-SanJuan, Carolina ; Álvarez, Marco Antonio ; Honrubia López, Raúl ; Quintana-Carbo, Sergi ; Martínez Ares, David ; Albéniz, Eduardo ; López-Cerón Pinilla, María ; Aicart-Ramos, Marta ; Rodríguez de Santiago, Enrique ; Uchima, Hugo ; Pérez de la Iglesia, Sandra ; Solano Sánchez, Marina ; Valdivielso Cortázar, Eduardo ; de Frutos, Diego ; Pellisé, María ; Fraile-López, Miguel ; Castro Quismondo, Nerea ; Dolz Abadía, Carlos ; Ramos Zabala, Felipe ; Marín-Gabriel, José Carlos ; Hijos-Mallada, Gonzalo ; Ocaña, Juan ; González Santiago, Jesús Manuel ; Hernández, Luis ; Gornals, Joan B. ; Cunha Neves, João A. ; Rodríguez Gandía, Miguel Ángel ; Martínez Martínez, Juan

Background:Delayed post-polypectomy bleeding (DPPB) is the most common adverse event following colonic polypectomy, yet its management remains highly heterogeneous and lacks standardization. A considerable number of colonoscopies performed for DPPB may be unnecessary and do not result in hemostatic intervention.Objectives:To develop evidence-based statements to guide clinical decision-making in DPPB.Design:Multidisciplinary Delphi consensus statement.Methods:A panel of 29 experts in gastroenterology, hematology, radiology, and surgery was assembled. Through a systematic review of the literature and a modified Delphi process, consensus statements were developed through iterative rounds of anonymous voting. Statements were revised following anonymous voting and feedback at each round. Those achieving 80% agreement were accepted.Results:The expert panel reached a consensus on 36 statements, covering areas such as antithrombotic management, bowel preparation, colonoscopy indications, and therapeutic hemostatic modalities. Key recommendations include guidance for managing self-limited bleeding and risk stratification to reduce the rate of unnecessary colonoscopies, as well as recommendations for hemodynamically unstable patients who may require primary angioembolization. A practical clinical algorithm is proposed.Conclusion:This document provides a consensus-based framework for managing DPPB. These recommendations aim to improve patient outcomes and optimize healthcare resources while fostering a standardized approach to this common adverse event.

100 Deals associated with Instituto De Investigación Sanitaria Puerta De Hierro-Segovia De Arana

100 Translational Medicine associated with Instituto De Investigación Sanitaria Puerta De Hierro-Segovia De Arana

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