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

• Sponsor: Shandong Provincial Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05808010
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Atrophic Gastritis	Biological: Mononuclear cells; Drug: Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Study of Umbilical Cord Blood Mononuclear Cell Therapy for the Treatment of Chronic Atrophic Gastritis
• Anticipated Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Apr 1, 2025
• Anticipated Study Completion Date: Apr 1, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change from baseline OLGA/OLGIM stages of gastric mucosa [At the first, seventh and thirteenth month of treatment]

   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

2. Change from baseline gastric mucosal status under gastroscope [At the first, seventh and thirteenth month of treatment]

   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

Secondary Outcome Measures

1. Change from baseline blood test result [At the first, seventh and thirteenth month of treatment]

   Assessment of Gastrin-17 and Pepsinogen I/II

2. Incidence of adverse reactions [Through follow-up period completion, an average of 1 year]

   Assessment of incidence of adverse reactions

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shandong Provincial Hospital	Jinan	Shandong	China	250021

Sponsors and Collaborators

• Shandong Provincial Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xu Hongwei, Chief Physician, Shandong Provincial Hospital
• ClinicalTrials.gov Identifier: NCT05808010
• Other Study ID Numbers: SWYX:NO.2022-1037
• First Posted: Apr 11, 2023
• Last Update Posted: Apr 11, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gastritis; Gastritis, Atrophic; Atrophy; Hydrotalcite

Study Results

No Results Posted as of Apr 11, 2023