Diabetes MellitusEarly Phase 1NCT06991829

Clinical Study on the Safety and Efficacy of Immunophenotyped Pancreatic Endocrine Organoid Bank in Treating Patients With T3c Diabetes

A Early Phase 1 study testing HLA-matched pancreatic endocrine organoids transplantation in people with Diabetes Mellitus, run by Shanghai Zhongshan Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Diabetes Mellitus
What is being tested?: HLA-matched pancreatic endocrine organoids transplantation
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 1 siteChina
Study dates: 3 Apr 2025to 31 Oct 2027
Phase: Early 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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged ≥18 and ≤70 years at the time of informed consent, regardless of sex; History of total pancreatectomy with baseline C-peptide levels below the lower limit of normal;
Post-pancreatectomy hyperglycemia consistent with diagnostic criteria for T3cDM;
Stimulated C-peptide level < 0.3 ng/mL at 120 minutes following a mixed meal;
HbA1c≥7.5% or TIR < 70% despite intensified insulin therapy;
Male participants who are sexually active and not surgically sterilized or whose partners are of childbearing potential must agree to use effective contraception and refrain from sperm donation throughout the study and for at least 6 months thereafter; female participants of childbearing potential must agree to use effective contraception for the duration of the study and for at least 6 months thereafter.
Voluntary written informed consent and willingness to comply with the study protocol and visit schedule.

Who cannot join

Known hemoglobinopathies or moderate-to-severe anemia interfering with HbA1c interpretation;
Positive HBsAg or HBcAb with HBV DNA ≥10⁴ copies/mL or ≥2000 IU/mL; Patients with positive HBsAg and HBV DNA <2000 IU/mL must be on antiviral therapy throughout the study. Patients with positive HBcAb and HBV DNA <2000 IU/mL must undergo regular HBV DNA monitoring;
Positive HCV antibody with HCV RNA≥10³IU/mL;
Positive HIV antibody testing;
Active syphilis infection (those with resolved infection may be included);
Existence or suspicion of other uncontrollable or untreatable fungal, bacterial, viral or other infections;

Show all 15Show fewer

Uncontrolled hypertension (SBP >160 mmHg and/or DBP >100 mmHg despite stable antihypertensive treatment for ≥4 weeks);
History of coagulopathy or long-term anticoagulation therapy (e.g., warfarin) or INR >1.5 (low-dose aspirin permitted);
Impaired liver function: AST or ALT >3× ULN Total bilirubin >2× ULN;
Impaired renal function with Creatinine clearance <45 mL/min (Cockcroft-Gault formula);
History of end-stage heart or lung disease, or cirrhosis;
Presence or history of any type of cancer, excluding papillary thyroid cancer cured for more than 1 year;
Severe mental/psychological disorders, or severe cognitive impairment
Pregnant or lactating women;
Other situations or abnormal findings judged by the investigator as unsuitable for participating in the trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Islet cells are isolated from resected pancreatic tissue obtained from patients undergoing surgery, followed by ex vivo expansion and culture. Subsequent procedures include HLA typing, functional assessment of organoid-like structures, and biobanking. After matching for HLA, the cells are administered into patients with type 3c diabetes mellitus (T3cDM) via ultrasound-guided percutaneous transhepatic portal vein catheterization. A 52-week follow-up is conducted to evaluate the safety of the cell therapy and its clinical efficacy in glycemic control.

Conditions: Diabetes Mellitus
Being tested: HLA-matched pancreatic endocrine organoids transplantation
Keywords: type 3c diabetes mellitus, pancreatic endocrine organoids, Islet Transplantation, HLA-immunotyped
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HLA-matched pancreatic endocrine organoids transplantationProcedure or surgery
Islet cells are isolated from resected pancreatic tissue obtained from patients undergoing surgery, followed by ex vivo expansion and culture. Subsequent procedures include HLA typing, functional assessment of organoid-like structures, and biobanking. After matching for HLA, the cells are administered into patients with type 3c diabetes mellitus (T3cDM) via ultrasound-guided percutaneous transhepatic portal vein catheterization. A 52-week follow-up is conducted to evaluate the safety of the cell therapy and its clinical efficacy in glycemic control.

Study groups in NCT06991829
Study group	Role	What they receive
HLA-matched pancreatic endocrine organoids transplantation	Experimental	Islet cells are isolated from resected pancreatic tissue obtained from patients undergoing surgery, followed by ex vivo expansion and culture. Subsequent procedures include HLA typing, functional assessment of organoid-like structures, and biobanking. After matching for HLA, the cells are administered into patients with type 3c diabetes mellitus (T3cDM) via ultrasound-guided percutaneous transhepatic portal vein catheterization. A 52-week follow-up is conducted to evaluate the safety of the cell therapy and its clinical efficacy in glycemic control. Receives: Procedure: HLA-matched pancreatic endocrine organoids transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Participants with ≥50% Reduction in Daily Insulin Dose at Week 52 Post-Transplantation Compared to Baseline
The percentage of participants whose daily insulin requirement is reduced by at least 50% at 52 weeks after organoid transplantation, compared to their baseline insulin dose.
Measured: From enrollment to the end of treatment at 52 weeks post-transplantation
Proportion of Participants with HbA1c < 7.0% at Week 52 Post-Transplantation
The percentage of participants achieving HbA1c levels <7.0% at 52 weeks post-transplantation, indicating improved long-term glycemic control.
Measured: From enrollment to the end of treatment at 52 weeks post-transplantation
Number of Participants with No Episodes of Severe Hypoglycemia Between Weeks 12 and 52 Post-Transplantation
The number of participants who report zero episodes of severe hypoglycemia during the 12 to 52 weeks post-transplantation period.
Measured: From Week 12 to Week 52 post-transplantation

Secondary outcomes (9)

Proportion of Participants with HbA1c < 7.0% at Weeks 12, 26, and 52 Post-Transplantation
Percentage of participants achieving HbA1c < 7.0% at each follow-up time point to assess glycemic control over time.
Measured: Weeks 12, 26, and 52 post-transplantation
Proportion of Participants with ≥50% Reduction in Daily Insulin Dose at Weeks 12, 26, and 52 Post-Transplantation
Percentage of participants whose insulin requirement is reduced by at least 50% at three time points post-transplantation.
Measured: Weeks 12, 26, and 52 post-transplantation
Proportion of Participants Achieving Insulin Independence at Weeks 26 and 52 Post-Transplantation
Percentage of participants who achieve complete insulin independence by Week 26 and Week 52.
Measured: Weeks 26 and 52 post-transplantation
Proportion of Participants with Stimulated C-Peptide Peak > 0.3 ng/mL Following a Mixed Meal Tolerance Test at Weeks 12, 26, and 52
Percentage of participants with stimulated C-peptide > 0.3 ng/mL at Weeks 12, 26, and 52, indicating β-cell functional recovery.
Measured: Weeks 12, 26, and 52 post-transplantation
Time-in-Range (TIR) at Weeks 12, 26, and 52 Post-Transplantation
Proportion of time during which blood glucose levels remain within target glycemic range, as measured by CGM.
Measured: Weeks 12, 26, and 52 post-transplantation
Mean Amplitude of Glycemic Excursions (MAGE) at Weeks 12, 26, and 52 Post-Transplantation
Glycemic variability measured by the average amplitude of glucose excursions as recorded by CGM.
Measured: Weeks 12, 26, and 52 post-transplantation
Cumulative Number of Hypoglycemic Episodes at Weeks 12, 26, and 52 Post-Transplantation
Number of documented hypoglycemic events recorded during follow-up.
Measured: Weeks 12, 26, and 52 post-transplantation
Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
Safety profile assessed by the number and type of adverse events recorded over the treatment period.
Measured: From enrollment to Week 52 post-transplantation.
Change in Quality of Life Scores from Baseline to Week 52 Post-Transplantation
Difference in patient-reported quality of life scores from baseline to Week 52.
Measured: From enrollment to the end of treatment at 52 weeks post-transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Apr 202531 Oct 2027

First posted28 May 2025
Study start3 Apr 2025
Primary completion3 Apr 2027 (estimated)
Study completion31 Oct 2027 (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 Shanghai Zhongshan 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: Early Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: A single-arm clinical trial is designed to evaluate whether transplantation of HLA-matched pancreatic endocrine organoids can effectively lower blood glucose levels in patients with diabetes following pancreatectomy. The trial employs Simon's Two-Stage Optimal Design to determine sample size, with parameters: P0 = 0.10 (null hypothesis), P1 = 0.30 (alternative hypothesis), α = 0.05, and β = 0.20. Given the lack of definitive treatments and the first-in-human nature of this intervention, 10 patients will be enrolled in the first stage. If ≥2 achieve treatment success, the trial proceeds to stage two; otherwise, it stops. In stage two, 19 more patients will be enrolled (total n=29). If ≥6 patients achieve treatment success, the therapy is considered effective; if \<6, it is considered ineffective.
Masking: None (open label)
Enrolment: 29 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06991829
Sponsor's protocol ID: ZSPAC-10
Status last verified: May 2025
First submitted: 15 Apr 2025
Last updated: 28 May 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Study Protocol, Statistical Analysis Plan (SAP) and Clinical Study Report (CSR)

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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)

All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study on the Safety and Efficacy of Immunophenotyped Pancreatic Endocrine Organoid Bank in Treating Patients With T3c Diabetes
ClinicalTrials.gov ID: NCT06991829
Acronym / sponsor ID: ZSPAC-10
Conditions: Diabetes Mellitus
Keywords: type 3c diabetes mellitus, pancreatic endocrine organoids, Islet Transplantation, HLA-immunotyped
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 29 participants (estimated)
Lead sponsor: Shanghai Zhongshan HospitalUniversity, hospital or other
Collaborators: Shanghai Newislet Therapeutics Co., Ltd.
Study start: 3 Apr 2025 (actual)
Primary completion: 3 Apr 2027 (estimated)
Study completion: 31 Oct 2027 (estimated)
First posted: 28 May 2025 (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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: A single-arm clinical trial is designed to evaluate whether transplantation of HLA-matched pancreatic endocrine organoids can effectively lower blood glucose levels in patients with diabetes following pancreatectomy. The trial employs Simon's Two-Stage Optimal Design to determine sample size, with parameters: P0 = 0.10 (null hypothesis), P1 = 0.30 (alternative hypothesis), α = 0.05, and β = 0.20. Given the lack of definitive treatments and the first-in-human nature of this intervention, 10 patients will be enrolled in the first stage. If ≥2 achieve treatment success, the trial proceeds to stage two; otherwise, it stops. In stage two, 19 more patients will be enrolled (total n=29). If ≥6 patients achieve treatment success, the therapy is considered effective; if <6, it is considered ineffective.

Arm	Type	Receives
HLA-matched pancreatic endocrine organoids transplantation	Experimental	Procedure: HLA-matched pancreatic endocrine organoids transplantationIslet cells are isolated from resected pancreatic tissue obtained from patients undergoing surgery, followed by ex vivo expansion and culture. Subsequent procedures include HLA typing, functional assessment of organoid-like structures, and biobanking. After matching for HLA, the cells are administered into patients with type 3c diabetes mellitus (T3cDM) via ultrasound-guided percutaneous transhepatic portal vein catheterization. A 52-week follow-up is conducted to evaluate the safety of the cell therapy and its clinical efficacy in glycemic control.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Aged ≥18 and ≤70 years at the time of informed consent, regardless of sex; History of total pancreatectomy with baseline C-peptide levels below the lower limit of normal;
Post-pancreatectomy hyperglycemia consistent with diagnostic criteria for T3cDM;
Stimulated C-peptide level < 0.3 ng/mL at 120 minutes following a mixed meal;
HbA1c≥7.5% or TIR < 70% despite intensified insulin therapy;
Male participants who are sexually active and not surgically sterilized or whose partners are of childbearing potential must agree to use effective contraception and refrain from sperm donation throughout the study and for at least 6 months thereafter; female participants of childbearing potential must agree to use effective contraception for the duration of the study and for at least 6 months thereafter.

Key exclusion criteria (15 listed)

Known hemoglobinopathies or moderate-to-severe anemia interfering with HbA1c interpretation;
Positive HBsAg or HBcAb with HBV DNA ≥10⁴ copies/mL or ≥2000 IU/mL; Patients with positive HBsAg and HBV DNA <2000 IU/mL must be on antiviral therapy throughout the study. Patients with positive HBcAb and HBV DNA <2000 IU/mL must undergo regular HBV DNA monitoring;
Positive HCV antibody with HCV RNA≥10³IU/mL;
Positive HIV antibody testing;
Active syphilis infection (those with resolved infection may be included);

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
HLA-matched pancreatic endocrine organoids transplantationIslet cells are isolated from resected pancreatic tissue obtained from patients undergoing surgery, followed by ex vivo expansion and culture. Subsequent procedures include HLA typing, functional assessment of organoid-like structures, and biobanking. After matching for HLA, the cells are administered into patients with type 3c diabetes mellitus (T3cDM) via ultrasound-guided percutaneous transhepatic portal vein catheterization. A 52-week follow-up is conducted to evaluate the safety of the cell therapy and its clinical efficacy in glycemic control.	Procedure or surgery	HLA-matched pancreatic endocrine organoids transplantation

Primary outcome

Proportion of Participants with ≥50% Reduction in Daily Insulin Dose at Week 52 Post-Transplantation Compared to Baseline
Time frame: From enrollment to the end of treatment at 52 weeks post-transplantation
The percentage of participants whose daily insulin requirement is reduced by at least 50% at 52 weeks after organoid transplantation, compared to their baseline insulin dose.
Proportion of Participants with HbA1c < 7.0% at Week 52 Post-Transplantation
Time frame: From enrollment to the end of treatment at 52 weeks post-transplantation
The percentage of participants achieving HbA1c levels <7.0% at 52 weeks post-transplantation, indicating improved long-term glycemic control.
Number of Participants with No Episodes of Severe Hypoglycemia Between Weeks 12 and 52 Post-Transplantation
Time frame: From Week 12 to Week 52 post-transplantation
The number of participants who report zero episodes of severe hypoglycemia during the 12 to 52 weeks post-transplantation period.

9 secondary outcomes

Proportion of Participants with HbA1c < 7.0% at Weeks 12, 26, and 52 Post-Transplantation
Time frame: Weeks 12, 26, and 52 post-transplantation
Proportion of Participants with ≥50% Reduction in Daily Insulin Dose at Weeks 12, 26, and 52 Post-Transplantation
Time frame: Weeks 12, 26, and 52 post-transplantation
Proportion of Participants Achieving Insulin Independence at Weeks 26 and 52 Post-Transplantation
Time frame: Weeks 26 and 52 post-transplantation
Proportion of Participants with Stimulated C-Peptide Peak > 0.3 ng/mL Following a Mixed Meal Tolerance Test at Weeks 12, 26, and 52
Time frame: Weeks 12, 26, and 52 post-transplantation
Time-in-Range (TIR) at Weeks 12, 26, and 52 Post-Transplantation
Time frame: Weeks 12, 26, and 52 post-transplantation
Mean Amplitude of Glycemic Excursions (MAGE) at Weeks 12, 26, and 52 Post-Transplantation
Time frame: Weeks 12, 26, and 52 post-transplantation
Cumulative Number of Hypoglycemic Episodes at Weeks 12, 26, and 52 Post-Transplantation
Time frame: Weeks 12, 26, and 52 post-transplantation
Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
Time frame: From enrollment to Week 52 post-transplantation.
Change in Quality of Life Scores from Baseline to Week 52 Post-Transplantation
Time frame: From enrollment to the end of treatment at 52 weeks post-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 28 May 2025.
Individual participant dataSharing planned: Yes. Study Protocol, Statistical Analysis Plan (SAP) and Clinical Study Report (CSR)

Related trials for Diabetes 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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing HLA-matched pancreatic endocrine organoids transplantation in people with Diabetes Mellitus, run by Shanghai Zhongshan 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 6 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 28 May 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

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?

Proportion of Participants with ≥50% Reduction in Daily Insulin Dose at Week 52 Post-Transplantation Compared to Baseline (time frame: From enrollment to the end of treatment at 52 weeks post-transplantation). 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?

On the ClinicalTrials.gov record for NCT06991829.

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 28 May 2025.