Clinical Study of Umbilical Cord Blood Mononuclear Cell Therapy for the Treatment of Chronic Atrophic Gastritis

To evaluate the efficacy and safety of umbilical cord blood mononuclear cells in the treatment of chronic atrophic gastritis.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Atrophic Gastritis
• Intervention / Treatment: Biological: Mononuclear cells; Drug: Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250021
      • Shandong Provincial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects voluntarily participated in the study and signed an informed consent.
2. The age is 18-65 years old, regardless of gender.
3. Patients with chronic atrophic gastritis by gastroscopy and pathological examination.
4. Patients with a negative C13 breath test or have eradicated Helicobacter pylori infection.
5. Patients without contraindications to submucosal injection of umbilical cord blood derived mononuclear cells.

Exclusion Criteria:

1. Patients with gastric ulcer, erosive gastritis, active upper gastrointestinal bleeding, gastric varices, or other gastric tumors.
2. Patients who are taking or have taken proton pump inhibitors, antibiotics, glucocorticoids, nonsteroidal anti-inflammatory drugs and immunosuppressants in the last six months.
3. People who have had gastric surgery or required gastric surgery during the study.
4. Patients with severe systemic diseases (diseases of cardiovascular, liver, blood, kidneys, lungs or liver).
5. Pregnant or nursing females.
6. Patients who are reluctant to accept endoscopy and treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mononuclear cells+Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules	Biological: Mononuclear cells; 2 times gastric submucosal injection of mononuclear cells (10^8) at 1 month interval; Drug: Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules; Orally delivered tablets for 7 months. Take it according to the instructions.
Experimental: Mononuclear cells; Mononuclear cells are obtained from umbilical cord blood by density gradient centrifugation	Biological: Mononuclear cells; 2 times gastric submucosal injection of mononuclear cells (10^8) at 1 month interval
Active Comparator: Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules; Weifuchun is a kind of edible Chinese herbal prescription	Drug: Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules; Orally delivered tablets for 7 months. Take it according to the instructions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline OLGA/OLGIM stages of gastric mucosa	Assessment of OLGA/OLGIM stages by GI pathologists. The obtained biopsy specimens will be scored using visual analogue scale (0, 1, 2, 3 points for none, mild, moderate and severe, respectively) to evaluate gastroatrophy and gastrointestinal metaplasia	At the first, seventh and thirteenth month of treatment
Change from baseline gastric mucosal status under gastroscope	Assessment of Kimura-Takemoto classification by endoscopy. The variation of atrophy can reflect the extent and degree of atrophy. The severity of atrophy increases gradually with C1-C2-C3-O1-O2-O3. Cases of closed-type gastric mucosa atrophy have an atrophic boundary between the fundic mucosa and the pyloric mucosa in the antrum or less curvature of the gastric body. Cases of open-type gastric mucosa atrophy have an atrophic boundary in the lateral wall or greater curvature of the gastric body. C, closed; O, open	At the first, seventh and thirteenth month of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline blood test result	Assessment of Gastrin-17 and Pepsinogen I/II	At the first, seventh and thirteenth month of treatment
Incidence of adverse reactions	Assessment of incidence of adverse reactions	Through follow-up period completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Shandong Provincial Hospital
• Investigators: Principal Investigator: hongwei Xu, MD, Shandong Provincial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: March 17, 2023
• First Submitted That Met QC Criteria: March 29, 2023
• First Posted (Actual): April 11, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Pathological Conditions, Anatomical; Gastritis; Atrophy; Gastritis, Atrophic; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Antacids; Hydrotalcite
• Other Study ID Numbers: SWYX:NO.2022-1037

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No