Brittle Type 1 DiabetesPhase 2NCT05990530
Allogeneic Transplantation of Expanded Pancreatic Islet Cells
A Phase 2 study testing YD02-2022 in people with Brittle Type 1 Diabetes, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This study will evaluate the efficacy and safety of allogeneic pancreatic islet cells transplantation in patients with "brittle" type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Brittle Type 1 Diabetes
- What is being tested?
- YD02-2022
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 22 Feb 2023to Aug 2025
- Phase
- Phase 2
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Voluntarily sign an informed consent form and agree to comply with the trial treatment plan and visit schedule.
- Age ≥18 years and ≤60 years on the day of signing the informed consent form, regardless of gender.
- Body mass index (BMI) ≥18.0 kg/m2 and ≤35.0 kg/m2.
- Diagnosed with T1DM based on the World Health Organization's diabetes classification (2019).
- HbA1c ≥7.0% and ≤15.0% at screening.
- Dependence on insulin injection therapy for ≥5 years, receiving a stable insulin treatment plan for ≥3 months, and injecting insulin three or more times per day or using an insulin pump.
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- Postprandial mixed meal stimulated C-peptide level <0.3 ng/mL.
- Experienced impaired awareness of hypoglycemia or significant glycemic instability during screening and in the past 6 months. Hypoglycemic episodes are associated with impaired awareness of hypoglycemia, extreme glycemic instability, or severe fear and maladaptive behavior.
- Sexually active males who are not surgically sterilized or have partners of childbearing potential agree to use effective contraception during the entire trial period and for at least 6 months after the study ends; sexually active females of childbearing potential agree to use effective contraception during the entire study period and for at least 6 months after the study ends.
Who cannot join
- Types of diabetes other than T1DM.
- Body mass index (BMI) >35 kg/m2 or weight <50 kg.
- Excessive insulin sensitivity and/or insulin resistance (insulin requirement >1.0 IU/kg/day or <15 U/day).
- Previous pancreatic or islet transplantation. Severe trauma, severe infection, or surgery that may affect glycemic control within one month before screening.
- History of hypertension with systolic blood pressure (SBP) >160 mmHg and/or diastolic blood pressure (DBP) >100 mmHg after stable dose (at least 4 weeks) of antihypertensive medication.
- Blood transfusion or severe bleeding within the past 3 months, known hemoglobin-related diseases, anemia (moderate to severe), or other known hemoglobinopathies that interfere with HbA1c measurement (such as sickle cell disease).
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- Impaired liver or kidney function at screening: aspartate aminotransferase (AST) ≥3 times the upper limit of normal (ULN), alanine aminotransferase (ALT) ≥3 times ULN, total bilirubin level (TBL) ≥2 times ULN (excluding Gilbert's syndrome), creatinine clearance rate <45 mL/min (calculated by the Cockcroft-Gault formula).
- Significant albuminuria (urinary albumin excretion rate >300 mg/g) or history thereof.
- Uncontrolled or untreated thyroid disease or adrenal insufficiency.
- Severe diabetic kidney disease or renal insufficiency, proliferative retinopathy, diabetic foot ulcers, diabetes-related amputation, and/or severe peripheral neuropathy at screening.
- Active hepatitis B, hepatitis C, acquired immunodeficiency syndrome, syphilis, or tuberculosis. Even without clinical evidence of active infection, participants with laboratory evidence of active infection are also excluded.
- Severe heart disease or a history of cardiovascular disease within 6 months before screening, including stroke, decompensated heart failure (NYHA class III or IV), myocardial infarction, unstable angina, or coronary artery bypass grafting.
- Previous history of coagulation disorders or requiring long-term anticoagulant therapy (e.g., warfarin) (low-dose aspirin therapy is allowed) or patients with INR >1.5.
- Substance abusers with a history of drug abuse/dependence or drug use within 1 year before screening.
- Received live vaccines within 14 days before screening or planned to receive live vaccines during the trial or within 1 month after treatment. Live vaccines include, but are not limited to, measles, mumps, rubella, varicella, yellow fever, rabies, Bacillus Calmette-Guérin, typhoid vaccine, COVID-19 vaccine, etc.
- Patients with a history of acute or chronic pancreatitis, symptomatic gallbladder disease, pancreatic injury, or other high-risk factors for pancreatitis, or patients with blood amylase >1.2 times ULN at screening.
- Other abnormal laboratory test results deemed clinically significant by the investigator.
- Patients with severe mental illness.
- Participated in a drug or medical device clinical trial within the past 3 months and received investigational drugs or medical devices; or within 5 half-lives of another drug before screening (if the half-life exceeds 3 months).
- Currently receiving long-term (continuous for ≥14 days) systemic pharmacological doses of glucocorticoids or other medications that may affect the participant's consciousness.
- Treatment (local, intra-articular, intraocular, or inhalation preparations) for any other factors or diseases not mentioned above, deemed unsuitable for participation in this clinical study by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Endocrinology and Metabolic Diseases, Ruijin Hospital, Shanghai Jiao-Tong University
Shanghai, 200025
Weiqiong Gu, PhD, 86-21-64370045 ext. 672701, Gwq10978@rjh.com.cn
About this study
Official title: Evaluation of the Efficacy and Safety of Allogeneic Transplantation of Expanded Pancreatic Islet Cells in Patients With "Brittle" Type 1 Diabetes
This study will evaluate the efficacy and safety of allogeneic pancreatic islet cells transplantation in patients with "brittle" type 1 diabetes.
- Conditions
- Brittle Type 1 Diabetes
- Being tested
- YD02-2022
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YD02-2022Biological
Human islet cells were isolated and expanded in vitro to generate islets containing all types of pancreatic endocrine cells and possessing comparable function of human islets. These islet cells will be infused into the hepatic portal vein.
| Study group | Role | What they receive |
|---|---|---|
| YD02-2022 | Experimental | Not described Receives: Biological: YD02-2022 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual β-Cell function (RBCF)
Evaluation of the magnitude of C-peptide change after transplantation
Measured: 12 months post-transplant
Secondary outcomes (6)
Glycemic control (HbA1c)
Evaluation of the proportion of subjects with HbA1c ≤7.0% and no severe hypoglycemic events
Measured: 52 weeks post-transplant
Treatment (insulin-independent)
Evaluation of the proportion of subjects who are insulin-independent
Measured: 12 weeks and 52 weeks post-transplant
Treatment (insulin requirement)
Evaluation of the percentage reduction in insulin requirement
Measured: 12 weeks and 52 weeks post-transplant
Glycemic control (MAGE)
Evaluation of the average amplitude of glycemic fluctuations (MAGE) in subjects
Measured: 12 weeks and 52 weeks post-transplant
Hypoglycemia (HYPO)
Evaluation of the severity of hypoglycemia using the Ryan Hypoglycemia Severity Score (HYPO)
Measured: baseline and 52 weeks post-transplant
Quality of life score
Evaluation of the quality of life score in subjects
Measured: baseline and 52 weeks post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start22 Feb 2023
- Primary completionAug 2024 (estimated)
- Study completionAug 2025 (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 DiabetesStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990530
- Sponsor's protocol ID
- YD02-2022
- Status last verified
- Aug 2023
- First submitted
- 7 Aug 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Allogeneic Transplantation of Expanded Pancreatic Islet Cells in Patients With "Brittle" Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05990530
- Acronym / sponsor ID
- YD02-2022
- Conditions
- Brittle Type 1 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 14 Aug 2023 (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 study will evaluate the efficacy and safety of allogeneic pancreatic islet cells transplantation in patients with "brittle" type 1 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YD02-2022 | Experimental | Biological: YD02-2022 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Voluntarily sign an informed consent form and agree to comply with the trial treatment plan and visit schedule.
- Age ≥18 years and ≤60 years on the day of signing the informed consent form, regardless of gender.
- Body mass index (BMI) ≥18.0 kg/m2 and ≤35.0 kg/m2.
- Diagnosed with T1DM based on the World Health Organization's diabetes classification (2019).
- HbA1c ≥7.0% and ≤15.0% at screening.
Key exclusion criteria (21 listed)
- Types of diabetes other than T1DM.
- Body mass index (BMI) >35 kg/m2 or weight <50 kg.
- Excessive insulin sensitivity and/or insulin resistance (insulin requirement >1.0 IU/kg/day or <15 U/day).
- Previous pancreatic or islet transplantation. Severe trauma, severe infection, or surgery that may affect glycemic control within one month before screening.
- History of hypertension with systolic blood pressure (SBP) >160 mmHg and/or diastolic blood pressure (DBP) >100 mmHg after stable dose (at least 4 weeks) of antihypertensive medication.
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 |
|---|---|---|
| YD02-2022Human islet cells were isolated and expanded in vitro to generate islets containing all types of pancreatic endocrine cells and possessing comparable function of human islets. These islet cells will be infused into the hepatic portal vein. | Biological | YD02-2022 |
Primary outcome
Residual β-Cell function (RBCF)
Time frame: 12 months post-transplant
Evaluation of the magnitude of C-peptide change after transplantation
6 secondary outcomes
Glycemic control (HbA1c)
Time frame: 52 weeks post-transplant
Treatment (insulin-independent)
Time frame: 12 weeks and 52 weeks post-transplant
Treatment (insulin requirement)
Time frame: 12 weeks and 52 weeks post-transplant
Glycemic control (MAGE)
Time frame: 12 weeks and 52 weeks post-transplant
Hypoglycemia (HYPO)
Time frame: baseline and 52 weeks post-transplant
Quality of life score
Time frame: baseline and 52 weeks post-transplant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YD02-2022 in people with Brittle Type 1 Diabetes, run by Shanghai Jiao Tong University School of Medicine 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 21 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 14 Aug 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Weiqiong Gu, PhD (86-21-64370045 ext. 671701, Gwq10978@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual β-Cell function (RBCF) (time frame: 12 months post-transplant). 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 14 Aug 2023.