Diabetes Mellitus, Type 1Phase 1NCT06731218
Phase I Clinical Study to Evaluate the Safety and Efficacy of RGB-5088 in Patients With Type 1 Diabetes Mellitus
A Phase 1 study testing RGB-5088 in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, run by Hangzhou Reprogenix Bioscience, Inc at 1 site in China.
Trial summary
This Phase I clinical trial is a single-center, single-arm, open-label study aimed at evaluating the safety and therapeutic efficacy of RGB-5088 islet cell transplantation in patients with Type 1 Diabetes Mellitus. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus
- What is being tested?
- RGB-5088
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 17 Feb 2025to 31 Dec 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18-60 years old (including 18 and 60 years old), male and female;
- Type 1 diabetes patients (including those who have received organ transplantation such as liver and kidney);
- Stimulated C-peptide < 0.3 ng/mL;
- The patient had at least one severe hypoglycemia within 12 months before being included in the project
Who cannot join
- Type 2 diabetes patients;
- Untreated proliferative diabetes retinopathy;
- Serious heart disease;
- Serious gastrointestinal dysfunction ；
- Serious psychological diseases；
- Any history of malignancy;
- Have a history of tobacco, alcohol and drug abuse;
- For female subjects: pregnancy test positive, lactation or unwilling to use effective contraceptive measures during the study period, male patients: intent to procreate or unwilling to use effective contraceptive measures during the study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin First Center Hospital
Tianjin, Tianjin Municipality, 300000
Zhongyang Shen, +86-22-23626606, zhongyangshen@sina.com
Zhongyang Shen
About this study
Official title: A Single-Center, Single-Arm, Open-Label Phase I Clinical Trial Evaluating the Safety and Efficacy of RGB-5088 Islet Cell Injection in the Treatment of Type 1 Diabetes Mellitus
This Phase I clinical trial is a single-center, single-arm, open-label study aimed at evaluating the safety and therapeutic efficacy of RGB-5088 islet cell transplantation in patients with Type 1 Diabetes Mellitus.
- Conditions
- Diabetes Mellitus, Type 1, Diabetes Mellitus
- Being tested
- RGB-5088
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RGB-5088Biological
Transplantation under the anterior rectus sheath
| Study group | Role | What they receive |
|---|---|---|
| RGB-5088 | Experimental | Transplantation under the anterior rectus sheath Receives: Biological: RGB-5088 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by number of subjects with adverse events
Measured: From RGB-5088 transplantation to one year later
Proportion of subjects with HbA1c ≤ 6.5% and free of severe hypoglycemic events
Measured: From 90 days to 365 days after RGB-5088 transplantation
Secondary outcomes (3)
Safety as assessed by number of subjects with adverse events
Measured: From RGB-5088 transplantation to end of study (up to 5 years)
Proportion of subjects who are insulin independent
Measured: From 90 days to end of study (up to 5 years)
Proportion of subjects with HbA1c ≤ 6.5% and free of severe hypoglycemic events
Measured: From 90 days to end of study (up to 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start17 Feb 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Reprogenix Bioscience, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731218
- Sponsor's protocol ID
- RGB-5088-01
- Status last verified
- Sep 2025
- First submitted
- 9 Dec 2024
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Single-Arm, Open-Label Phase I Clinical Trial Evaluating the Safety and Efficacy of RGB-5088 Islet Cell Injection in the Treatment of Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06731218
- Acronym / sponsor ID
- RGB-5088-01
- Conditions
- Diabetes Mellitus, Type 1, Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hangzhou Reprogenix Bioscience, IncIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 12 Dec 2024 (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.
This Phase I clinical trial is a single-center, single-arm, open-label study aimed at evaluating the safety and therapeutic efficacy of RGB-5088 islet cell transplantation in patients with Type 1 Diabetes Mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RGB-5088 | Experimental | Biological: RGB-5088Transplantation under the anterior rectus sheath |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 18-60 years old (including 18 and 60 years old), male and female;
- Type 1 diabetes patients (including those who have received organ transplantation such as liver and kidney);
- Stimulated C-peptide < 0.3 ng/mL;
- The patient had at least one severe hypoglycemia within 12 months before being included in the project
Key exclusion criteria (8 listed)
- Type 2 diabetes patients;
- Untreated proliferative diabetes retinopathy;
- Serious heart disease;
- Serious gastrointestinal dysfunction ；
- Serious psychological diseases；
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 |
|---|---|---|
| RGB-5088Transplantation under the anterior rectus sheath | Biological | RGB-5088 |
Primary outcome
Safety as assessed by number of subjects with adverse events
Time frame: From RGB-5088 transplantation to one year later
Proportion of subjects with HbA1c ≤ 6.5% and free of severe hypoglycemic events
Time frame: From 90 days to 365 days after RGB-5088 transplantation
3 secondary outcomes
Safety as assessed by number of subjects with adverse events
Time frame: From RGB-5088 transplantation to end of study (up to 5 years)
Proportion of subjects who are insulin independent
Time frame: From 90 days to end of study (up to 5 years)
Proportion of subjects with HbA1c ≤ 6.5% and free of severe hypoglycemic events
Time frame: From 90 days to end of study (up to 5 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RGB-5088 in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, run by Hangzhou Reprogenix Bioscience, Inc 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 15 Sep 2025. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linlin Jiang (+86+571-88601920, Linlin.jiang@reprogenix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as assessed by number of subjects with adverse events (time frame: From RGB-5088 transplantation to one year later). 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 15 Sep 2025.