Diabetes MellitusNCT07464119
A Clinical Study of iPSC-Derived Islet Cells for Diabetes Mellitus Therapy
A study testing iPSC-derived islet cell in people with Diabetes Mellitus, run by Peking University First Hospital at 1 site in China.
Trial summary
This is a single-arm, open-label clinical trial designed to assess the safety and therapeutic efficacy of iPSC-derived islet cell infusion in patients with diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- iPSC-derived islet cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2026to 31 Dec 2033
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 18 years or older, of any sex.
- Duration of diabetes > 5 years.
- Body mass index (BMI) 18-35 kg/m².
- Receiving insulin therapy.
Who cannot join
- Presence of HIV infection , or active acute or chronic hepatitis infection (HBV or HCV), or Treponema pallidum infection.
- Active pulmonary tuberculosis or patients undergoing treatment for suspected tuberculosis.
- Uncontrolled systemic fungal, bacterial, viral, or other infections .
- Presence of severe diabetic complications.
- Presence of severe organic lesions in vital organs such as the heart, lungs, or brain.
- History of malignant tumors.
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 First Hospital
Beijing
Wang, 86 18811770199, zw_wang@bjmu.edu.cn
About this study
Official title: A Single-Arm, Open-Label Clinical Study of iPSC-Derived Islet Cells for the Treatment of Diabetes Mellitus
This is a single-arm, open-label clinical trial designed to assess the safety and therapeutic efficacy of iPSC-derived islet cell infusion in patients with diabetes mellitus.
- Conditions
- Diabetes Mellitus
- Being tested
- iPSC-derived islet cell
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPSC-derived islet cellBiological
iPSC-derived islet cell infusion
| Study group | Role | What they receive |
|---|---|---|
| iPSC-derived islet cell | Experimental | Not described Receives: Biological: iPSC-derived islet cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: From enrollment to month 6
Secondary outcomes (2)
Change from baseline in glycosylated hemoglobin (HbA1c)
Measured: From enrollment to month 6
Change from baseline in exogenous insulin dosage
Measured: From enrollment to month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start16 Mar 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Reprogenix Bioscience, Inc
- Responsible party
- Principal investigator, Zhang Junqing, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464119
- Sponsor's protocol ID
- RGB-Y0201
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label Clinical Study of iPSC-Derived Islet Cells for the Treatment of Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07464119
- Acronym / sponsor ID
- RGB-Y0201
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Hangzhou Reprogenix Bioscience, Inc
- Study start
- 16 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 11 Mar 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 is a single-arm, open-label clinical trial designed to assess the safety and therapeutic efficacy of iPSC-derived islet cell infusion in patients with 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 |
|---|---|---|
| iPSC-derived islet cell | Experimental | Biological: iPSC-derived islet cell |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects aged 18 years or older, of any sex.
- Duration of diabetes > 5 years.
- Body mass index (BMI) 18-35 kg/m².
- Receiving insulin therapy.
Key exclusion criteria (6 listed)
- Presence of HIV infection , or active acute or chronic hepatitis infection (HBV or HCV), or Treponema pallidum infection.
- Active pulmonary tuberculosis or patients undergoing treatment for suspected tuberculosis.
- Uncontrolled systemic fungal, bacterial, viral, or other infections .
- Presence of severe diabetic complications.
- Presence of severe organic lesions in vital organs such as the heart, lungs, or brain.
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 |
|---|---|---|
| iPSC-derived islet celliPSC-derived islet cell infusion | Biological | iPSC-derived islet cell |
Primary outcome
Adverse events
Time frame: From enrollment to month 6
2 secondary outcomes
Change from baseline in glycosylated hemoglobin (HbA1c)
Time frame: From enrollment to month 6
Change from baseline in exogenous insulin dosage
Time frame: From enrollment to month 6
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 11 Mar 2026.
- Individual participant dataSharing planned: No
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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 study testing iPSC-derived islet cell in people with Diabetes Mellitus, run by Peking University First 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 4 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: opening soon, as of the sponsor's last update on 11 Mar 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: From enrollment to month 6). 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 11 Mar 2026.