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Strengthening the weakness of the lower esophageal sphincter leads to reflux with stem cells derived from human adipose tissue.

Results assessment of autologous implantation of human Adipose derived stem cells in augment of lower esophageal sphincter weakness leading to gastroesophageal reflux : a phase I clinical trial

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20181113041635N2
Enrollment
24
Registered
2019-08-16
Start date
2019-07-23
Completion date
Unknown
Last updated
2019-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal reflux. Oesophageal reflux NOS

Interventions

Intervention 1: Intervention group: Injection of 8 million stem cells derived from human adipose tissue injection, suspended in 3 ml buffer phosphate solution, by endoscopy in the lower esophageal sph

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Age of 18 to 60 years Without hiatal herniation Without barretts esophagus Without chronic disease Without pregnancy Without morbidly obese Gastroesophageal reflux Proven weakness of the lower esophageal sphincter

Exclusion criteria

Exclusion criteria: Those who are very old and it is difficult to get data from them Individuals with chronic illnesses, such as heart or kidney failure, and it is difficult to get data from them Individuals with congenital esophageal disorders Individuals who participated in a clinical trial within the last 6 months Those who have severe weight gain and it is difficult to get data from them Individuals who do not have personal consent to participate in the study

Design outcomes

Primary

MeasureTime frame
Esophageal sphincter pressure. Timepoint: At the beginning of the study (before the intervention), the first week after the intervention, the second week after the intervention, the first month after the intervention, the third month after the intervention and the sixth month after the intervention. Method of measurement: manometry.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactArash Sarveazad

Iran University of Medical Sciences

Arashsarveazad@gmail.com+98 21 6655 4790

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026