Esophageal Stenosis AcquiredNCT07913646
Adipose-derived Stem Cells in Treatment of Esophageal Strictures
A study testing Adipose-derived stem cells and stromal vascular fraction in people with Esophageal Stenosis Acquired, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Stenosis Acquired
- What is being tested?
- Adipose-derived stem cells and stromal vascular fraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNorway
- Study dates
- 1 Nov 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Benign esophageal stricture diagnosed by endoscopy and histology Refractory stenosis defined as previous balloon or bougie dilation treatment at least ten times
- Length of stricture up to 3.0 cm
Who cannot join
- The use of platelet inhibitors other than acetylsalicylic acid, BMI < 18 or > 35, liver cirrhosis, other significant comorbidity such as COPD GOLD 3-4, unstable coronary heart disease, current malignant disease.
- WHO performance status >1.
- Previous scarring in abdominal subcutaneous tissue making fat grafting difficult
- Previous non-adherence to scheduled follow-up
- Unable to understand Norwegian or unable to sign informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Treatment of Refractory Benign Esophageal Stricture by Endoscopic Injection of Adipose-derived Stem Cells and Stromal Vascular Fraction
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.
Read more
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.
Read the detailed description
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
- Benign esophageal stricture diagnosed by endoscopy and histology Refractory stenosis defined as previous balloon or bougie dilation treatment at least ten times
- Length of stricture up to 3.0 cm
Exclusion criteria
- The use of platelet inhibitors other than acetylsalicylic acid, BMI < 18 or > 35, liver cirrhosis, other significant comorbidity such as COPD GOLD 3-4, unstable coronary heart disease, current malignant disease.
- WHO performance status >1.
- Previous scarring in abdominal subcutaneous tissue making fat grafting difficult
- Previous non-adherence to scheduled follow-up
- Unable to understand Norwegian or unable to sign informed consent
Primary outcomes
- Resolution of dysphagia defined as Mellow Pinkas score = 0 or an improvement of ≥ 2 points during follow-up and luminal diameter ≥ 13 mm.
Secondary outcomes
- Stricture diameter at endoscopies after treatment. Luminal diameter ≥13 mm defined as complete resolution.
- Time to stricture requiring new dilation, due to symptoms and diameter <13 mm.
- Adverse events or complications
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
- Deep sedation administration by anesthesiologist in addition to local anesthesia infiltration will be given.
- Stromal vascular fraction (SVF) with adipose-derived stem cells (ADSCs) and nanofat will be obtained by liposuction, mechanical rupturing of adipose cells before centrifugation following previously published protocols.
- The esophageal stricture will be dilated to the maximal diameter perceived safe by the endoscopy team.
- Nanofat injection. Thereafter, injections of 0.5 ml will be delivered in each octant for each 1 cm of the length of the stenosis in the submucosal layer. The injections will be delivered through a endoscopic injection needle.
Evaluation of outcomes after the procedure Two weeks
- Telephone call
- Open question concerning side effects
- Dysphagia score (Mellow Pinkas) One month
- Dysphagia score (Mellow Pinkas)
- Upper endoscopy with measured diameter of stricture Two months
- Dysphagia score (Mellow Pinkas)
- Upper endoscopy with measured diameter of stricture Six months
- Dysphagia score (Mellow Pinkas)
- Upper endoscopy with measured diameter of stricture
- Review of medical record focused on need for stricture dilations
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.
- Conditions
- Esophageal Stenosis Acquired
- Being tested
- Adipose-derived stem cells and stromal vascular fraction
- Keywords
- esophagus, stricture
- Medical subject headings
- Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose-derived stem cells and stromal vascular fractionProcedure or surgery
Adipose-derived stem cells and stromal vascular fraction will be injected into benign esophageal strictures in all patients (n=10).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Adipose derived stem cells and stromal vascular fraction will be injected in the benign esophageal stricture Receives: Procedure: Adipose-derived stem cells and stromal vascular fraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Six months
Secondary outcomes (3)
Esophageal diameter
Stricture diameter at endoscopies after treatment.
Measured: Six months
Time to stricture requiring new dilation
Time to stricture requiring new (rescue) dilation, due to symptoms and diameter <13 mm
Measured: Six months
Adverse events
Adverse events or complications
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Stenosis AcquiredStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reidar Fossmark, Oslo University Hospital
- Investigators
- Reidar Fossmark, MD, PhD, Principal investigator, Oslo University Hospital, Ullevål, Oslo Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913646
- Sponsor's protocol ID
- 933837
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is restricted by the Regional Committees for Medical Research Ethics South East Norway
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Refractory Benign Esophageal Stricture by Endoscopic Injection of Adipose-derived Stem Cells and Stromal Vascular Fraction
- ClinicalTrials.gov ID
- NCT07913646
- Acronym / sponsor ID
- 933837
- Conditions
- Esophageal Stenosis Acquired
- Keywords
- esophagus, stricture
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- Benign esophageal stricture diagnosed by endoscopy and histology Refractory stenosis defined as previous balloon or bougie dilation treatment at least ten times
- Length of stricture up to 3.0 cm
Exclusion criteria
- The use of platelet inhibitors other than acetylsalicylic acid, BMI < 18 or > 35, liver cirrhosis, other significant comorbidity such as COPD GOLD 3-4, unstable coronary heart disease, current malignant disease.
- WHO performance status >1.
- Previous scarring in abdominal subcutaneous tissue making fat grafting difficult
- Previous non-adherence to scheduled follow-up
- Unable to understand Norwegian or unable to sign informed consent
Primary outcomes
- Resolution of dysphagia defined as Mellow Pinkas score = 0 or an improvement of ≥ 2 points during follow-up and luminal diameter ≥ 13 mm.
Secondary outcomes
- Stricture diameter at endoscopies after treatment. Luminal diameter ≥13 mm defined as complete resolution.
- Time to stricture requiring new dilation, due to symptoms and diameter <13 mm.
- Adverse events or complications
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
- Deep sedation administration by anesthesiologist in addition to local anesthesia infiltration will be given.
- Stromal vascular fraction (SVF) with adipose-derived stem cells (ADSCs) and nanofat will be obtained by liposuction, mechanical rupturing of adipose cells before centrifugation following previously published protocols.
- The esophageal stricture will be dilated to the maximal diameter perceived safe by the endoscopy team.
- Nanofat injection. Thereafter, injections of 0.5 ml will be delivered in each octant for each 1 cm of the length of the stenosis in the submucosal layer. The injections will be delivered through a endoscopic injection needle.
Evaluation of outcomes after the procedure Two weeks
- Telephone call
- Open question concerning side effects
- Dysphagia score (Mellow Pinkas) One month
- Dysphagia score (Mellow Pinkas)
- Upper endoscopy with measured diameter of stricture Two months
- Dysphagia score (Mellow Pinkas)
- Upper endoscopy with measured diameter of stricture Six months
- Dysphagia score (Mellow Pinkas)
- Upper endoscopy with measured diameter of stricture
- Review of medical record focused on need for stricture dilations
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Adipose-derived stem cells and stromal vascular fractionAdipose derived stem cells and stromal vascular fraction will be injected in the benign esophageal stricture |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Benign esophageal stricture diagnosed by endoscopy and histology Refractory stenosis defined as previous balloon or bougie dilation treatment at least ten times
- Length of stricture up to 3.0 cm
Key exclusion criteria (5 listed)
- The use of platelet inhibitors other than acetylsalicylic acid, BMI < 18 or > 35, liver cirrhosis, other significant comorbidity such as COPD GOLD 3-4, unstable coronary heart disease, current malignant disease.
- WHO performance status >1.
- Previous scarring in abdominal subcutaneous tissue making fat grafting difficult
- Previous non-adherence to scheduled follow-up
- Unable to understand Norwegian or unable to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adipose-derived stem cells and stromal vascular fractionAdipose-derived stem cells and stromal vascular fraction will be injected into benign esophageal strictures in all patients (n=10). | Procedure or surgery | Intervention |
Primary outcome
Resolution of dysphagia and esophageal stricture
Time frame: Six months
Resolution of dysphagia defined as Mellow Pinkas score = 0 or an improvement of ≥ 2 points and esophageal luminal diameter ≥ 13 mm
3 secondary outcomes
Esophageal diameter
Time frame: Six months
Time to stricture requiring new dilation
Time frame: Six months
Adverse events
Time frame: Six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No. This is restricted by the Regional Committees for Medical Research Ethics South East Norway
Related trials for Esophageal Stenosis Acquired
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reidar Fossmark, MD, PhD principal investigator
Oslo University Hospital, Ullevål, Oslo Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adipose-derived stem cells and stromal vascular fraction in people with Esophageal Stenosis Acquired, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of dysphagia and esophageal stricture (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.