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Physician reports esophagus regenerated with stents and human tissue
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A successful regeneration of the esophagus using off-the-shelf, commercially available FDA-approved stents and donated human skin used off-label, resulted in restoration of swallowing function with weight maintenance in a patient with a severely damaged esophagus. Though these techniques found previous success in animals, this is the first human case reported
“In this particular case, there was significant damage from a big abscess. … The upper esophagus was significantly damaged leading to a direct communication between the pharynx and the chest cavity.” Kulwinder Dua, MD, DMSc, FRCP, FACP, FASGE, from the Medical College of Wisconsin, Milwaukee, told Healio Gastroenterology. “When all the standard of care was exhausted, including multiple surgeries, … we went in with principles of regenerative medicine that have so far been successfully validated in animal studies to address this life-threatening condition in this unfortunate patient.”
Kulwinder Dua
Dua and colleagues’ report in The Lancet details the building of a scaffold using self-expanding metal stents and adding regenerative tissue matrix from donated human skin covered in platelet-rich plasma gel for the 5-cm reconstruction of this 24-year-old patient’s esophagus.
“We ended up in a life threatening situation where we didn’t know where to go,” Dua said. “All of this was done to save someone’s life.”
Though they planned to remove the stents 12 weeks after the procedure, that was delayed for almost 4 years at the patient’s request as he feared leakage or scarring with obstruction after the stents are removed. One year after removal, structural and functional evaluation with endoscopic ultrasound and motility studies showed a five-layered esophageal wall with peristaltic propagating contractions.
Now, 7 years after the initial procedure and 4 years after removal of the stents, the patient reports no difficulty in swallowing and maintains a healthy weight, according to the publication. Dua noted that more than 60% of patients who have part of their esophagus removed for conditions such as cancer and then traditionally repaired by gastric pull-up conduits or colon interpositions report lifelong side-effects with a poor quality of life. Esophageal regeneration to restore normal physiology would be ideal for these patients, he explained.
Still, he cautions other physicians to understand this still needs to be thoroughly investigated.
“We stumbled on a situation where we had a bedside situation that now must be taken to the bench,” he said. “We were in uncharted territory and therefore I would be very cautious in saying this is what we should do. We need to do large-scale animal studies, phase 1 and 2 studies. We have to answer many more questions.”
Currently, Dua and his colleagues are looking into the feasibility of animal studies and, once those are confirmed, he plans to look at children with congenital defects of the esophagus.
“If someone is cornered, … by all means one can innovate. That will be on clinical grounds,” he said, citing another case where he had similar successes.
In an accompanying commentary, Martin Birchall, MA, MD, FRCS, FRCS, FRCS, of the Royal National Throat, Nose and Ear Hospital, London, and Paolo De Coppi, MD, PhD, of the Great Ormond Street Hospital for Children NHS Foundation Trust, London, echoed Dua’s sentiment that more research is needed.
“The endoscopic ultrasound data are crucial to understanding the contribution of the implanted graft material. These data seem to confirm complete regeneration of all layers of the oesophagus with a cell-free engineered construct, a remarkable finding given the presumed complexity of this organ,” they wrote. “Reverse translation should drive this group and others to test the hypothesis generated by this clinical success. If an accelerated treatment process, backed by well designed animal studies and based on the learning points we mention here, successfully replicates the observations reported by Dua and coworkers in formal phase 1 and 2 clinical trials, the method might have an important bearing on oesophageal surgery for benign and malignant conditions.”
Disclosure: Dua, Birchall and De Coppi report no relevant financial disclosures.
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