Brittle Type 1 Diabetes MellitusNCT06196996
Allogeneic Regenerative Islet Transplantation for the Treatment of Brittle Type 1 Diabetes Mellitus
A study testing The method of islet transplantation is through percutaneous transhepatic portal vein puncture. in people with Brittle Type 1 Diabetes Mellitus, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
This is a single-center, single-arm Phase Investigational Intervention Trial (IIT) clinical trial aimed at evaluating the safety and efficacy of allogeneic regenerative islet transplantation for the treatment of brittle type 1 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 6 to 65 years
- Conditions the study is for
- Brittle Type 1 Diabetes Mellitus
- What is being tested?
- The method of islet transplantation is through percutaneous transhepatic portal vein puncture.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 14 Sep 2021to Sep 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 6 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 6-65 years, gender not specified.
- Despite intensified exogenous insulin therapy, blood glucose control remains inadequate [glycated hemoglobin ≥7.5%, or TIR (time in range) <70%].
- Able and willing to use the blood glucose meter provided by the sponsor, conduct self-blood glucose monitoring as required, and complete the patient log as instructed.
- Fertile eligible subjects (male or female) must agree to use a reliable contraceptive method (hormonal or barrier method or abstinence) during the trial and for at least 90 days after the last dose; premenopausal female patients must have a negative pregnancy test before enrollment.
- Diagnosed with type 1 diabetes for at least 1 year based on the World Health Organization (WHO) disease diagnostic criteria, and at least one positive result for diabetes-related autoantibodies [glutamic acid decarboxylase autoantibody (GADA), insulinoma-associated-2 autoantibody (IA-2A), insulin autoantibody (IAA), islet cell antibody (ICA), zinc transporter 8 antibody (ZaT8A)]. Experiencing two or more severe hypoglycemic events in the past year, with at least one severe hypoglycemic event in the past 3 months (severe hypoglycemia defined as blood glucose below 2.9 mmol/L or inability to self-correct during hypoglycemia).
- Voluntarily participate and sign the informed consent form.
Who cannot join
- Uncontrolled systemic infections, including but not limited to pulmonary tuberculosis, active hepatitis, a history of positive human immunodeficiency virus (HIV) testing, and positive syphilis treponemal antibody (TP);
- Presence of significant organic lesions in vital organs such as the heart, lungs, or brain;
- Complications of severe diabetes, including but not limited to retinal hemorrhage, diabetic foot, etc.;
- Liver function tests with total bilirubin, ALT, and AST ≥2×ULN, and failure to normalize after drug treatment;
- Untreated cancer or less than 1 year since cure;
- Severe gastrointestinal dysfunction, gastrointestinal immune diseases, and inability to take immunosuppressant;
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- History of smoking, alcohol abuse, or drug misuse;
- Severe mental or psychological disorders;
- Various advanced metabolic diseases (such as hyperuricemia, etc.);
- Participation in other clinical trials in the 3 months prior to enrollment;
- Patients requiring long-term oral/intravenous administration of high-dose glucocorticoids due to various diseases;
- Pregnant or lactating women;
- Investigator judgment indicating clear evidence of severe, active, uncontrolled endocrine or autoimmune abnormalities other than type 1 diabetes;
- Other situations judged by the investigator as unsuitable for participation in the trial.
Trial locations and contacts
1 site in 1 country.
Hao Yin contact
China1 site, 1 recruiting
- Recruiting
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality
Hao Yin, 13901677738, yinhaoshanghai@163.com
About this study
Official title: Allogeneic Regenerative Islet Transplantation for the Treatment of Brittle Type 1 Diabetes Mellitus: A Clinical Study Evaluating Safety and Efficacy
This is a single-center, single-arm Phase Investigational Intervention Trial (IIT) clinical trial aimed at evaluating the safety and efficacy of allogeneic regenerative islet transplantation for the treatment of brittle type 1 diabetes mellitus. Eighteen patients with brittle type 1 diabetes mellitus, who have inadequate blood glucose control despite intensified exogenous insulin therapy, will be enrolled. The primary endpoint is defined as the safety and improvement in blood glucose levels of the 12 months after allogeneic regenerative islet transplantation.
- Conditions
- Brittle Type 1 Diabetes Mellitus
- Being tested
- The method of islet transplantation is through percutaneous transhepatic portal vein puncture.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The method of islet transplantation is through percutaneous transhepatic portal vein puncture.Procedure or surgery
The method of islet transplantation is through percutaneous transhepatic portal vein puncture.After transplantation, rabbit anti human thymocyte immunoglobulin (ATG) or basiliximab was used as induction therapy and low-dose tacrolimus combined with sirolimus or mycophenolate mofetil were used as immunosuppressive maintenance therapy.
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic Regenerative Islet Transplantation for the Treatment of Brittle Type 1 Diabetes Mellitus | Experimental | Not described Receives: Procedure: The method of islet transplantation is through percutaneous transhepatic portal vein puncture. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Range
Changes in patient blood glucose time in range from baseline
Measured: up to 12 months
HbA1c
Changes in patient HbA1c levels from baseline during the study period
Measured: up to 12 months
C-peptide
Changes in patient fasting and postprandial C-peptide/insulin from baseline during the study period
Measured: up to 12 months
insulin
Changes in patient fasting and postprandial insulin from baseline during the study period
Measured: up to 12 months
Secondary outcomes (1)
Dose of exogenous insulin
Changes in daily exogenous insulin requirements during the study period
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start14 Sep 2021
- Primary completionDec 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brittle Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng 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
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hao Yin, Principal investigator, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196996
- Sponsor's protocol ID
- ZXHZ-IIT-02
- Status last verified
- Dec 2023
- First submitted
- 13 Dec 2023
- Last updated
- 9 Jan 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 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Regenerative Islet Transplantation for the Treatment of Brittle Type 1 Diabetes Mellitus: A Clinical Study Evaluating Safety and Efficacy
- ClinicalTrials.gov ID
- NCT06196996
- Acronym / sponsor ID
- ZXHZ-IIT-02
- Conditions
- Brittle Type 1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 9 Jan 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 is a single-center, single-arm Phase Investigational Intervention Trial (IIT) clinical trial aimed at evaluating the safety and efficacy of allogeneic regenerative islet transplantation for the treatment of brittle type 1 diabetes mellitus. Eighteen patients with brittle type 1 diabetes mellitus, who have inadequate blood glucose control despite intensified exogenous insulin therapy, will be enrolled. The primary endpoint is defined as the safety and improvement in blood glucose levels of the 12 months after allogeneic regenerative islet transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allogeneic Regenerative Islet Transplantation for the Treatment of Brittle Type 1 Diabetes Mellitus | Experimental | Procedure: The method of islet transplantation is through percutaneous transhepatic portal vein puncture. |
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age 6-65 years, gender not specified.
- Despite intensified exogenous insulin therapy, blood glucose control remains inadequate [glycated hemoglobin ≥7.5%, or TIR (time in range) <70%].
- Able and willing to use the blood glucose meter provided by the sponsor, conduct self-blood glucose monitoring as required, and complete the patient log as instructed.
- Fertile eligible subjects (male or female) must agree to use a reliable contraceptive method (hormonal or barrier method or abstinence) during the trial and for at least 90 days after the last dose; premenopausal female patients must have a negative pregnancy test before enrollment.
- Diagnosed with type 1 diabetes for at least 1 year based on the World Health Organization (WHO) disease diagnostic criteria, and at least one positive result for diabetes-related autoantibodies [glutamic acid decarboxylase autoantibody (GADA), insulinoma-associated-2 autoantibody (IA-2A), insulin autoantibody (IAA), islet cell antibody (ICA), zinc transporter 8 antibody (ZaT8A)]. Experiencing two or more severe hypoglycemic events in the past year, with at least one severe hypoglycemic event in the past 3 months (severe hypoglycemia defined as blood glucose below 2.9 mmol/L or inability to self-correct during hypoglycemia).
Key exclusion criteria (14 listed)
- Uncontrolled systemic infections, including but not limited to pulmonary tuberculosis, active hepatitis, a history of positive human immunodeficiency virus (HIV) testing, and positive syphilis treponemal antibody (TP);
- Presence of significant organic lesions in vital organs such as the heart, lungs, or brain;
- Complications of severe diabetes, including but not limited to retinal hemorrhage, diabetic foot, etc.;
- Liver function tests with total bilirubin, ALT, and AST ≥2×ULN, and failure to normalize after drug treatment;
- Untreated cancer or less than 1 year since cure;
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 |
|---|---|---|
| The method of islet transplantation is through percutaneous transhepatic portal vein puncture.The method of islet transplantation is through percutaneous transhepatic portal vein puncture.After transplantation, rabbit anti human thymocyte immunoglobulin (ATG) or basiliximab was used as induction therapy and low-dose tacrolimus combined with sirolimus or mycophenolate mofetil were used as immunosuppressive maintenance therapy. | Procedure or surgery | Allogeneic Regenerative Islet Transplantation for the Treatment of Brittle Type 1 Diabetes Mellitus |
Primary outcome
Time in Range
Time frame: up to 12 months
Changes in patient blood glucose time in range from baseline
HbA1c
Time frame: up to 12 months
Changes in patient HbA1c levels from baseline during the study period
C-peptide
Time frame: up to 12 months
Changes in patient fasting and postprandial C-peptide/insulin from baseline during the study period
insulin
Time frame: up to 12 months
Changes in patient fasting and postprandial insulin from baseline during the study period
1 secondary outcome
Dose of exogenous insulin
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 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.
Hao Yin contact
Hao Yin principal investigator
Shanghai Changzheng 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 The method of islet transplantation is through percutaneous transhepatic portal vein puncture. in people with Brittle Type 1 Diabetes Mellitus, run by Shanghai Changzheng 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 14 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 9 Jan 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?
Contact Hao Yin (13901677738, yinhaoshanghai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in Range (time frame: up to 12 months). The study lists 4 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 9 Jan 2024.