Back to resultsClinical Study of Umbilical Cord Blood Mononuclear Cell Therapy for the Treatment of Chronic Atrophic Gastritis
Primary Purpose
Chronic Atrophic Gastritis
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Mononuclear cells
Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Atrophic Gastritis
Eligibility Criteria
Inclusion Criteria: Subjects voluntarily participated in the study and signed an informed consent. The age is 18-65 years old, regardless of gender. Patients with chronic atrophic gastritis by gastroscopy and pathological examination. Patients with a negative C13 breath test or have eradicated Helicobacter pylori infection. Patients without contraindications to submucosal injection of umbilical cord blood derived mononuclear cells. Exclusion Criteria: Patients with gastric ulcer, erosive gastritis, active upper gastrointestinal bleeding, gastric varices, or other gastric tumors. Patients who are taking or have taken proton pump inhibitors, antibiotics, glucocorticoids, nonsteroidal anti-inflammatory drugs and immunosuppressants in the last six months. People who have had gastric surgery or required gastric surgery during the study. Patients with severe systemic diseases (diseases of cardiovascular, liver, blood, kidneys, lungs or liver). Pregnant or nursing females. Patients who are reluctant to accept endoscopy and treatment.
Sites / Locations
- Shandong Provincial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Mononuclear cells+Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules
Mononuclear cells
Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules
Arm Description
Mononuclear cells are obtained from umbilical cord blood by density gradient centrifugation
Weifuchun is a kind of edible Chinese herbal prescription
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Change from baseline blood test result
Assessment of Gastrin-17 and Pepsinogen I/II
Incidence of adverse reactions
Assessment of incidence of adverse reactions
Full Information
NCT ID
NCT05808010
First Posted
March 17, 2023
Last Updated
July 14, 2023
Sponsor
Shandong Provincial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05808010
Brief Title
Clinical Study of Umbilical Cord Blood Mononuclear Cell Therapy for the Treatment of Chronic Atrophic Gastritis
Official Title
Clinical Study of Umbilical Cord Blood Mononuclear Cell Therapy for the Treatment of Chronic Atrophic Gastritis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2023 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong Provincial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To evaluate the efficacy and safety of umbilical cord blood mononuclear cells in the treatment of chronic atrophic gastritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Atrophic Gastritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mononuclear cells+Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules
Arm Type
Experimental
Arm Title
Mononuclear cells
Arm Type
Experimental
Arm Description
Mononuclear cells are obtained from umbilical cord blood by density gradient centrifugation
Arm Title
Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules
Arm Type
Active Comparator
Arm Description
Weifuchun is a kind of edible Chinese herbal prescription
Intervention Type
Biological
Intervention Name(s)
Mononuclear cells
Intervention Description
2 times gastric submucosal injection of mononuclear cells (10^8) at 1 month interval
Intervention Type
Drug
Intervention Name(s)
Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules
Intervention Description
Orally delivered tablets for 7 months. Take it according to the instructions.
Primary Outcome Measure Information:
Title
Change from baseline OLGA/OLGIM stages of gastric mucosa
Description
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
Time Frame
At the first, seventh and thirteenth month of treatment
Title
Change from baseline gastric mucosal status under gastroscope
Description
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
Time Frame
At the first, seventh and thirteenth month of treatment
Secondary Outcome Measure Information:
Title
Change from baseline blood test result
Description
Assessment of Gastrin-17 and Pepsinogen I/II
Time Frame
At the first, seventh and thirteenth month of treatment
Title
Incidence of adverse reactions
Description
Assessment of incidence of adverse reactions
Time Frame
Through follow-up period completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects voluntarily participated in the study and signed an informed consent.
The age is 18-65 years old, regardless of gender.
Patients with chronic atrophic gastritis by gastroscopy and pathological examination.
Patients with a negative C13 breath test or have eradicated Helicobacter pylori infection.
Patients without contraindications to submucosal injection of umbilical cord blood derived mononuclear cells.
Exclusion Criteria:
Patients with gastric ulcer, erosive gastritis, active upper gastrointestinal bleeding, gastric varices, or other gastric tumors.
Patients who are taking or have taken proton pump inhibitors, antibiotics, glucocorticoids, nonsteroidal anti-inflammatory drugs and immunosuppressants in the last six months.
People who have had gastric surgery or required gastric surgery during the study.
Patients with severe systemic diseases (diseases of cardiovascular, liver, blood, kidneys, lungs or liver).
Pregnant or nursing females.
Patients who are reluctant to accept endoscopy and treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hongwei Xu, MD
Phone
15168889328
Email
xhwsdslyy@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hongwei Xu, MD
Organizational Affiliation
Shandong Provincial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250021
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Clinical Study of Umbilical Cord Blood Mononuclear Cell Therapy for the Treatment of Chronic Atrophic Gastritis
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