Novel method enables safe delivery of stem cells in critically ill patients on external lung support

A multidisciplinary clinical team led by Professor Bernat Soria from the Institute of Bioengineering at the Miguel Hernández University of Elche (UMH, Spain) has developed a new method to deliver cell therapies in patients on extracorporeal membrane oxygenation (ECMO), a life support system used in cases of severe lung failure.

The advance has been published in Stem Cell Research & Therapy. The team has opted not to patent the technique in order to encourage its use in public health systems once further clinical testing is completed.

The method—named CIBA, for “Consecutive Intrabronchial Administration”—enables the delivery of stem-cell-based treatments directly into the alveoli of critically ill patients who cannot receive standard intravenous cell therapy due to the ECMO system’s constraints.

Until now, cell therapies were nearly impossible to administer to ECMO patients, as intravenous infusion risked clogging the system’s gas-exchange membranes. The CIBA method solves this technical barrier through controlled, fractionated intrabronchial delivery, depositing the therapeutic cells precisely where needed without interfering with the ECMO circuit.

“What we’ve achieved,” explains Prof. Soria, “is a safe way to deliver regenerative therapies when all other options are blocked. Imagine watering a fragile plant, but the watering can would flood it. CIBA allows us to drip-feed the therapy gently and exactly where it’s needed—right into the lungs.”

A first-of-its-kind administration in pediatric ECMO

The method was first applied under compassionate use in a 2-year-old patient with end-stage interstitial lung disease and no possibility of lung transplantation. Despite multiple immunosuppressive treatments and over three months of ECMO support, the child’s condition remained critical.

With authorization from the Spanish Agency of Medicines and Medical Devices (AEMPS), a single dose of Wharton’s jelly-derived mesenchymal stromal cells (WJ-MSCs) was administered intrabronchially using the CIBA method.

The procedure was well tolerated, and the patient was successfully extubated within 72 hours. However, weeks later, his condition deteriorated again, and ECMO support was withdrawn after 127 days, in agreement with his family.

“CIBA did not cure the underlying disease,” says Prof. Soria, “but it demonstrated, for the first time, that cell therapies can be delivered safely in ECMO patients. That’s a breakthrough. We now have a new therapeutic door to open.”

How does it work?

Mesenchymal stromal cells (MSCs), which can be sourced from the umbilical cord, bone marrow, adipose tissue, or dental pulp, are not yet specialized and can migrate to damaged tissue, modulate inflammation, and promote regeneration. Once in the lungs, these cells interact with immune cells like alveolar macrophages, releasing anti-inflammatory signals that help prevent tissue damage and support healing.

This new route of administration avoids systemic circulation and targets the lungs directly, maximizing the therapeutic effect and minimizing risk. The team notes that higher doses or repeated administrations could be explored in future trials.

A national collaboration committed to open science

This proof-of-concept study is part of the DECODE clinical project. It involved 28 clinicians from four national institutions: Hospital 12 de Octubre (Madrid), Banc de Sang i Teixits (Catalonia), the Institute of Bioengineering at UMH (Elche), and the Institute for Health and Biomedical Research of Alicante (ISABIAL).

“Advanced therapies are already expensive enough,” states Prof. Soria. “We chose not to patent this technique because it should reach patients without adding more cost. We’re committed to public science with direct clinical impact.”