Clinical Research Directory

Adipose-derived Stem Cells in Treatment of Esophageal Strictures

Sponsor: Oslo University Hospital

Summary

The goal of this clinical trial is to examine the effect of injection of adipose tissue derived stem cells in benign esophageal strictures in patients who have previously required at least 10 balloon dilations without satisfactory results on symptoms and esophageal diameter. This pilot trial will primarily examine the effects of the intervention on resolution of dysphagia and achieving a diameter ≥13 mm of the esophageal lumen. The trial will investigate dysphagia after two weeks, one, two and six months and diameter of the esophagus after one, two and six months. The trial will also record the following secondary outcomes: stricture diameter at each endoscopy, time to stricture requiring new dilation due to symptoms and diameter \< 13 mm as well as adverse events. Participants will be required to undergo a procedure which starts by harvesting of adipose tissue from the abdominal subcutaneous fat. A concentrate of stem cells and supportive cells will be prepared on site, before balloon dilation of the esophageal stricture and then injection of the cell preparation within the dilated stricture. Participants will then undergo follow-up after: * Two weeks: telephone call, open question concerning side effects and dysphagia score * One month: dysphagia score and upper endoscopy with measured diameter of stricture * Two months: dysphagia score and upper endoscopy with measured diameter of stricture * Six months: dysphagia score and upper endoscopy with measured diameter of stricture. The patient will at any timepoint contact the hospital if symptoms occur and an endoscopy with dilation is needed (rescue dilation). The time from intervention to rescue dilation will then be recorded.

Official title: Treatment of Refractory Benign Esophageal Stricture by Endoscopic Injection of Adipose-derived Stem Cells and Stromal Vascular Fraction

Key Details

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Interventions

Locations (1)