- The breakthrough enables the delivery of stem cell–based treatments directly into the lungs of patients supported with extracorporeal membrane oxygenation
Alicante (14.04.25). A multidisciplinary clinical team with the participation of the Alicante Institute for Health and Biomedical Research (ISABIAL), under the Regional Ministry of Health, has developed a new method to administer cellular therapies in critically ill patients connected to extracorporeal membrane oxygenation systems. This advance, led by ISABIAL researcher and Professor at Miguel Hernández University (UMH), Bernat Soria, has been published in the journal Stem Cell Research & Therapy of the Nature group. The researchers have decided not to patent the invention in order to facilitate its clinical application once all prior trials have been completed.
The new approach, named the CIBA method (Consecutive Intrabronchial Administration), enables the delivery of stem cell–based treatments directly into the lungs of patients supported with extracorporeal membrane oxygenation (ECMO), a type of life-support system used in cases of severe respiratory failure.
Until now, one of the main limitations in applying advanced therapies in these patients was the incompatibility between conventional administration routes (such as intravenous delivery) and the functioning of ECMO systems, since the cells could obstruct the membranes responsible for gas exchange. The CIBA method overcomes this technical barrier through controlled, fractionated intrabronchial administration, allowing therapeutic cells to be deposited in the alveolar space without compromising life-support function.
Researcher Bernat Soria explained that “what we have achieved is to open a new door for treating the most severe respiratory failures. When a patient needs a machine to breathe for them, cell therapies could not be administered through the usual routes, because the cells could clog the system. Our method makes it possible to deliver them directly into the lung without putting the patient at risk. It is like carefully watering a very delicate plant: little by little and exactly where it is needed”.
The new method enables the administration of mesenchymal stem cells directly into the bronchi. These cells, which are not yet fully specialized and can differentiate into several cell types, can be obtained from bone marrow, umbilical cord, adipose tissue, or dental pulp. Once administered, they have the ability to migrate toward damaged tissues, reduce inflammation, and promote lung repair.
The specialist also explained that “during residency, trainees delve into more complex techniques, but it is important for them to have a solid understanding of the fundamentals. There is little literature on this subject, and it is an area in which in‑depth training is essential. That is why we have been so committed to promoting this specialised training”.
A safe pathway for delivering cell therapies in critically ill patients
According to the researchers, this strategy has proven to be feasible and safe in the clinical context described, and it could open a new therapeutic pathway for critically ill patients suffering from lung diseases of inflammatory, immunological, or infectious origin.
“Patients with severe lung diseases requiring extracorporeal membrane oxygenation usually have a very limited prognosis and very few therapeutic options”, noted Bernat Soria. As indicated in the study, although mesenchymal stem cells have shown beneficial effects in inflammatory, immunological, and infectious diseases, their use in these cases had been hindered by the difficulty of administering them without interfering with life-support systems. “The new CIBA method solves this problem for the first time”, the researcher stated.
The method proposed by Bernat Soria’s team has been developed within the DECODE clinical trial (ICI21/00016 – Combinatorial Cell Therapy in High Mortality Risk Patients), funded by the Carlos III Health Institute, and represents a key step toward extending the use of advanced therapies —both cell‑based and gene‑based— to critically ill patients. The research team has chosen not to patent the technique, publishing it in open access to facilitate its immediate implementation in other hospital centres. “Advanced therapies are already expensive enough. This innovation must reach patients at zero cost”, stated UMH professor Bernat Soria.
First clinical use of the CIBA method in a paediatric patient
The new method was applied for the first time in a two‑year‑old child with severe interstitial lung disease, who was not eligible for lung transplantation and had a previous history of successful treatment for a brain tumour. Despite multiple immunosuppressive therapies and more than three months on extracorporeal membrane oxygenation, the child’s lung condition did not improve and no therapeutic options remained available.
Faced with this critical situation, the medical team requested authorization from the Spanish Agency of Medicines and Medical Devices (AEMPS) to administer a single dose of mesenchymal stem cells using the CIBA method. The intervention was carried out without complications, the patient tolerated it well, and was extubated 72 hours later. However, in the following weeks, the child’s respiratory condition deteriorated again. After 127 days on life-support, and in agreement with the family, life-support measures were withdrawn.
“The new CIBA method was not able to cure the underlying lung disease”, explains the ISABIAL researcher and UMH professor, “but it demonstrates that it is possible to administer cell therapies to critically ill patients on extracorporeal oxygenation — something that had not been achieved safely until now. It is a first step toward opening new options where none previously existed”. The published study proposes using a higher dose and repeating administrations if considered necessary.
The study involved 28 clinical professionals from four institutions within the national health system and the academic sector: Hospital 12 de Octubre in Madrid, the Banc de Sang i Teixits de Catalunya, the UMH Institute of Bioengineering, and the Alicante Institute for Health and Biomedical Research (ISABIAL). This collaboration, which researcher Bernat Soria has described as “an example of coordination between hospitals, biobanks, and academic research”, enables progress in the clinical translation of cell therapies in scenarios of high medical complexity.
