NCT05808010

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 11, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 7, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

1.8 years

First QC Date

March 17, 2023

Last Update Submit

April 15, 2024

Conditions

Chronic Atrophic Gastritis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Change from baseline blood test result

    At the first, seventh and thirteenth month of treatment

  • Incidence of adverse reactions

    Through follow-up period completion, an average of 1 year

Study Arms (3)

Mononuclear cells+Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules

EXPERIMENTAL
Biological: Mononuclear cellsDrug: Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules

Mononuclear cells

EXPERIMENTAL

Mononuclear cells are obtained from umbilical cord blood by density gradient centrifugation

Biological: Mononuclear cells

Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules

ACTIVE COMPARATOR

Weifuchun is a kind of edible Chinese herbal prescription

Drug: Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules

Interventions

Mononuclear cellsBIOLOGICAL

2 times gastric submucosal injection of mononuclear cells (10\^8) at 1 month interval

Mononuclear cellsMononuclear cells+Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules
Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate GranulesDRUG

Orally delivered tablets for 7 months. Take it according to the instructions.

Mononuclear cells+Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate GranulesWeifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

Location

MeSH Terms

Conditions

Gastritis, Atrophic

Condition Hierarchy (Ancestors)

GastritisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Study Officials

  • hongwei Xu, MD

    Shandong Provincial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

March 17, 2023

First Posted

April 11, 2023

Study Start

June 7, 2023

Primary Completion

April 1, 2025

Study Completion

April 1, 2026

Last Updated

April 17, 2024

Record last verified: 2024-04

Locations

CN(1)