Clinical study of mesenchymal stem cells in the treatment of gastroesophageal reflux disease

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100044338

Enrollment

Unknown

Registered

2021-03-16

Start date

2021-04-01

Completion date

Unknown

Last updated

2021-09-07

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

Conditions

Gastroesophageal reflux disease

Interventions

Stem cell transplantation group:Transplantation of mesenchymal stem cells into lower esophageal sphincter

Standard PPI treatment group:Oral standard dose PPI

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. GERD diagnosis is clear: (1) recurrent recurrent reflux, heartburn and other common symptoms or chest pain (except for the external cardiorespiratory chest pain), upper abdominal pain, upper abdomen burning sensation, belching and other atypical symptoms, can be accompanied by asthma, chronic cough, idiopathic pulmonary fibrosis, hoarseness, throat symptoms and other esophageal manifestations; (2) The gastroscope can be diagnosed by the detection of reflux esophagitis and the exclusion of esophageal lesions; (3) If pH of esophagus was detected in patients with negative endoscopy, the following indexes were met: acid exposure time was more than 6% or 24-hour reflux event was more than 80 times (Lyon consensus); 2. if the above GERD diagnostic criteria are met, patients who are not effective in 3 months of standard PPI treatment or who need to take standard PPI drugs for a long time (more than 1 year) and cannot stop the drug can be diagnosed as refractory GERD; 3. aged 18 to 65 years men and women.

Exclusion criteria

Exclusion criteria: 1. The patients with contraindication of endoscopy; 2. Patients with severe complications, functional heartburn, eosinophilic esophagitis, peptic ulcer, esophageal stricture, gastrointestinal tumor, esophageal and gastric surgery; 3. patients with coagulation dysfunction (INR > 1.4, PTT > 37 seconds), thrombocytopenia (PLT 180 / 100mmhg), body temperature > 38 degrees C; 10. participating in other clinical trials; 11. unable or unwilling to sign informed consent and scale; 12. positive pregnancy test for women of childbearing age.

Design outcomes

Primary

Measure	Time frame
Gerd-q scale;	—

Countries

China

Contacts

Public ContactLinghu Enqiang

Chinese PLA General Hospital

linghuenqiang@vip.sina.com+86 13501233558

Outcome results

None listed

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