Chronic Atrophic GastritisNCT05808010
Clinical Study of Umbilical Cord Blood Mononuclear Cell Therapy for the Treatment of Chronic Atrophic Gastritis
A study testing Mononuclear cells and Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules in people with Chronic Atrophic Gastritis, run by Shandong Provincial Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of umbilical cord blood mononuclear cells in the treatment of chronic atrophic gastritis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Atrophic Gastritis
- What is being tested?
- Mononuclear cells and Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 7 Jun 2023to Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the efficacy and safety of umbilical cord blood mononuclear cells in the treatment of chronic atrophic gastritis.
- Conditions
- Chronic Atrophic Gastritis
- Being tested
- Mononuclear cells, Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules
- Medical subject headings
- Gastritis, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mononuclear cellsBiological
2 times gastric submucosal injection of mononuclear cells (10^8) at 1 month interval
Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate GranulesDrug
Orally delivered tablets for 7 months. Take it according to the instructions.
| Study group | Role | What they receive |
|---|---|---|
| Mononuclear cells+Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules | Experimental | Not described Receives: Biological: Mononuclear cells; Drug: Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules |
| Mononuclear cells | Experimental | Mononuclear cells are obtained from umbilical cord blood by density gradient centrifugation Receives: Biological: Mononuclear cells |
| Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules | Active comparator | Weifuchun is a kind of edible Chinese herbal prescription Receives: Drug: Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: At the first, seventh and thirteenth month of treatment
Secondary outcomes (2)
Change from baseline blood test result
Assessment of Gastrin-17 and Pepsinogen I/II
Measured: At the first, seventh and thirteenth month of treatment
Incidence of adverse reactions
Assessment of incidence of adverse reactions
Measured: Through follow-up period completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start7 Jun 2023
- Primary completionApr 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Atrophic GastritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Xu Hongwei, Shandong Provincial Hospital
- Investigators
- hongwei Xu, MD, Principal investigator, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808010
- Sponsor's protocol ID
- SWYX:NO.2022-1037
- Status last verified
- Apr 2024
- First submitted
- 17 Mar 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Umbilical Cord Blood Mononuclear Cell Therapy for the Treatment of Chronic Atrophic Gastritis
- ClinicalTrials.gov ID
- NCT05808010
- Acronym / sponsor ID
- SWYX:NO.2022-1037
- Conditions
- Chronic Atrophic Gastritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 11 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of umbilical cord blood mononuclear cells in the treatment of chronic atrophic gastritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mononuclear cells+Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules | Experimental | Biological: Mononuclear cells, Drug: Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules |
| Mononuclear cells | Experimental | Biological: Mononuclear cellsMononuclear cells are obtained from umbilical cord blood by density gradient centrifugation |
| Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules | Active comparator | Drug: Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate GranulesWeifuchun is a kind of edible Chinese herbal prescription |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mononuclear cells2 times gastric submucosal injection of mononuclear cells (10^8) at 1 month interval | Biological | Mononuclear cells, Mononuclear cells+Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules |
| Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate GranulesOrally delivered tablets for 7 months. Take it according to the instructions. | Drug | Mononuclear cells+Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules, Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules |
Primary outcome
Change from baseline OLGA/OLGIM stages of gastric mucosa
Time frame: 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
Change from baseline gastric mucosal status under gastroscope
Time frame: 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
2 secondary outcomes
Change from baseline blood test result
Time frame: At the first, seventh and thirteenth month of treatment
Incidence of adverse reactions
Time frame: Through follow-up period completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hongwei Xu, MD principal investigator
Shandong Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mononuclear cells and Weifuchun+Hydrotalcite/L-Glutamine and Sodium Gualenate Granules in people with Chronic Atrophic Gastritis, run by Shandong Provincial Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline OLGA/OLGIM stages of gastric mucosa (time frame: At the first, seventh and thirteenth month of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.