Diabete MellitusPhase 1NCT07794254
A Clinical Study to Evaluate the Safety and Efficacy of RGB-5088 in Patients With Type 2 Diabetes Mellitus
A Phase 1 study testing RGB-5088 in people with Diabete Mellitus and Diabete Type 2, run by Hangzhou Reprogenix Bioscience, Inc at 1 site in China.
Trial summary
This Phase I clinical trial is a multi-center, single-arm, open-label study aimed at evaluating the safety and efficacy of RGB-5088 islet cell infusion in patients with Type 2 Diabetes Mellitus. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabete Mellitus, Diabete Type 2
- 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
- 30 Sep 2026to 30 Dec 2032
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years (inclusive), male or female.
- Diagnosis of type 2 diabetes mellitus (T2DM) with a disease duration ≥5 years.
- Body mass index (BMI) 18-30 kg/m².
- Glycated hemoglobin (HbA1c) 7.0%-10.0%.
- Adherence to guideline-recommended diet and exercise control; willing and able to comply with lifestyle interventions throughout the study.
- On insulin therapy following adequate trials of standard and advanced glucose-lowering regimens as per guidelines.
Show all 9Show fewer
- Subjects are dependent on insulin therapy.
- Women of childbearing potential, or male participants whose partners are of childbearing potential, must agree to use highly effective contraception throughout the study and for at least 6 months post-treatment.
- Able to understand the study protocol, willing to participate voluntarily, and provide signed written informed consent.
Who cannot join
- Diagnosis of any form of diabetes other than T2DM.
- Daily insulin dose >1.5 U/kg or total daily dose <20 U.
- Fasting plasma glucose ≥15.0 mmol/L.
- Positive for any diabetes-related autoantibodies at screening (prior to adipose tissue collection).
- Proliferative diabetic retinopathy requiring treatment or unstable.
- Active infection; hepatitis B, hepatitis C, syphilis, HIV antibody positivity; or history of tuberculosis.
Show all 22Show fewer
- History of major cardiovascular or cerebrovascular disease.
- Uncontrolled hypertension despite pharmacological therapy.
- Clinically significant abnormal liver function tests.
- Clinically significant abnormal renal function tests.
- Clinically significant abnormalities in hematology parameters.
- Positive pregnancy test; breastfeeding.
- History of malignant tumor, except for malignancies with an excellent expected prognosis after curative treatment.
- History of tobacco dependence, alcohol abuse, substance abuse, or illicit drug use.
- Use of concomitant medications (other than current antidiabetic agents) that, in the Investigator's opinion, may interfere with glycemic control.
- Any active autoimmune disease or history of autoimmune disease deemed by the Investigator to be incompatible with study participation.
- Documented history of a psychiatric disorder.
- History of hemoglobinopathy, other significant hematological disorders, or any condition causing hemolysis or erythrocyte instability.
- Participation in another interventional clinical trial within 3 months prior to signing the Informed Consent Form.
- Prior islet cell infusion/transplantation.
- Receipt of any other stem cell therapy.
- Judged by the Investigator to have poor compliance or unwillingness to adhere to study procedures.
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
Peking University People's Hospital
Beijing, Beijing Municipality
Linong Ji
About this study
Official title: A Single-Arm, Open-Label Phase I Clinical Trial Evaluating the Safety and Efficacy of RGB-5088 Islet Cell Injection in the Treatment of Type 2 Diabetes Mellitus
This Phase I clinical trial is a multi-center, single-arm, open-label study aimed at evaluating the safety and efficacy of RGB-5088 islet cell infusion in patients with Type 2 Diabetes Mellitus.
- Conditions
- Diabete Mellitus, Diabete Type 2
- Being tested
- RGB-5088
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
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 achieving HbA1c <7.0% or a reduction from baseline ≥1%
Measured: On Day180 post RGB-5088 transplantation
Proportion of subjects achieving HbA1c <7.0% or a reduction from baseline ≥1%
Measured: On Day365 post 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 achieving HbA1c <7.0% or a reduction from baseline ≥1%
Measured: Up to 5 years post RGB-5088 transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete MellitusStudies 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
- Investigators
- Linong Ji, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794254
- Sponsor's protocol ID
- RGB-5088-02
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 8 Sep 2026
- 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label Phase I Clinical Trial Evaluating the Safety and Efficacy of RGB-5088 Islet Cell Injection in the Treatment of Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07794254
- Acronym / sponsor ID
- RGB-5088-02
- Conditions
- Diabete Mellitus, Diabete Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hangzhou Reprogenix Bioscience, IncIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2032 (estimated)
- First posted
- 31 Aug 2026 (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 multi-center, single-arm, open-label study aimed at evaluating the safety and efficacy of RGB-5088 islet cell infusion in patients with Type 2 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 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-65 years (inclusive), male or female.
- Diagnosis of type 2 diabetes mellitus (T2DM) with a disease duration ≥5 years.
- Body mass index (BMI) 18-30 kg/m².
- Glycated hemoglobin (HbA1c) 7.0%-10.0%.
- Adherence to guideline-recommended diet and exercise control; willing and able to comply with lifestyle interventions throughout the study.
Key exclusion criteria (22 listed)
- Diagnosis of any form of diabetes other than T2DM.
- Daily insulin dose >1.5 U/kg or total daily dose <20 U.
- Fasting plasma glucose ≥15.0 mmol/L.
- Positive for any diabetes-related autoantibodies at screening (prior to adipose tissue collection).
- Proliferative diabetic retinopathy requiring treatment or unstable.
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 achieving HbA1c <7.0% or a reduction from baseline ≥1%
Time frame: On Day180 post RGB-5088 transplantation
Proportion of subjects achieving HbA1c <7.0% or a reduction from baseline ≥1%
Time frame: On Day365 post 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 achieving HbA1c <7.0% or a reduction from baseline ≥1%
Time frame: Up to 5 years post RGB-5088 transplantation
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 8 Sep 2026.
Related trials for Diabete Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Linong Ji principal investigator
Peking University People's Hospital
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 Diabete Mellitus and Diabete Type 2, 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 9 inclusion and 22 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: opening soon, as of the sponsor's last update on 8 Sep 2026. 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 3 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 8 Sep 2026.