An interventional study of Adipose-derived stem cells and stromal vascular fraction in Esophageal Stenosis Acquired, sponsored by Oslo University Hospital. Enrolling by invitation at 1 site in Norway. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Oslo University Hospital · Not applicable, Interventional, and Treatment
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:
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.
The primary aims of the study are 1) to evaluate improvements in stricture severity and patient symptoms, and 2) to monitor for any adverse effects.
Patients 18-80 years, n = 10
Inclusion criteria
Exclusion criteria
Primary outcomes
Secondary outcomes
Procedures and timeline for follow-up Dysphagia scoring and endoscopic assessment of stricture diameter. Dysphagia scoring will be performed before procedure start. The endoscopy will start with assessment of stricture diameter measured using an open biopsy forceps (7.5 mm) for lumen less than 6 mm, balloon inflation or bougie insertion depending on stricture location for larger lumen diameters. The estimated diameter will be defined as the first size with resistance when pulling the instrument through the stricture.
Baseline characteristics will be recorded based on an interview and information extracted from the medical record, including age, sex, BMI, medication, etiology of stenosis and time since surgery
Interventional procedure
Evaluation of outcomes after the procedure Two weeks
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.
456 studies on the registry are indexed under Constriction, Pathologic; 109 are open to participants now.
This study's planned enrollment of 10 is below the median of 72 across 295 interventional studies indexed under Constriction, Pathologic.
Browse Constriction, Pathologic studies →Oslo University Hospital is the lead sponsor of 834 studies on the registry; 149 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adipose derived stem cells and stromal vascular fraction will be injected in the benign esophageal stricture
Procedure: Adipose-derived stem cells and stromal vascular fraction
Adipose-derived stem cells and stromal vascular fraction will be injected into benign esophageal strictures in all patients (n=10).
Resolution of dysphagia and esophageal stricture
Resolution of dysphagia defined as Mellow Pinkas score = 0 or an improvement of ≥ 2 points and esophageal luminal diameter ≥ 13 mm
Time frame: Six months
Esophageal diameter
Stricture diameter at endoscopies after treatment.
Time frame: Six months
Time to stricture requiring new dilation
Time to stricture requiring new (rescue) dilation, due to symptoms and diameter \<13 mm
Time frame: Six months
Adverse events
Adverse events or complications
Time frame: Six months
Plan to share: No — This is restricted by the Regional Committees for Medical Research Ethics South East Norway
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2027, 13 months later.
Of 90 non-industry interventional studies with no phase under Constriction, Pathologic, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 49. This study's planned 13 months is below that.
Counting every sponsor, half of 133 studies reached it within 36 months; a quarter within 18 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.