Actively Recruiting
Allogeneic Regenerative Islet Transplantation for the Treatment of Brittle Type 1 Diabetes Mellitus
Led by Shanghai Changzheng Hospital · Updated on 2024-01-09
18
Participants Needed
1
Research Sites
259 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Allogeneic Regenerative Islet Transplantation for the Treatment of Brittle Type 1 Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 6 and 65 years
- Poor blood glucose control despite intensified insulin therapy (HbA1c 6.5% or time in range <70%)
- Able and willing to use the sponsor-provided blood glucose meter, perform self-monitoring, and complete patient logs
- Fertile participants must agree to use reliable contraception during the trial and for 90 days after last dose; premenopausal women must test negative for pregnancy before enrollment
- Diagnosed with type 1 diabetes for at least 1 year, with at least one positive diabetes-related autoantibody
- Experienced two or more severe hypoglycemic events in the past year, including at least one in the past 3 months
- Voluntary participation with signed informed consent
You will not qualify if you...
- Uncontrolled systemic infections (e.g., tuberculosis, active hepatitis, HIV positive, syphilis positive)
- Significant damage to vital organs such as heart, lungs, or brain
- Severe diabetes complications such as retinal hemorrhage or diabetic foot
- Liver function tests with total bilirubin, ALT, or AST 2 times upper limit of normal not improving after treatment
- Untreated cancer or cancer cured less than 1 year ago
- Severe gastrointestinal dysfunction or immune diseases preventing immunosuppressant use
- History of smoking, alcohol abuse, or drug misuse
- Severe mental or psychological disorders
- Advanced metabolic diseases like hyperuricemia
- Participation in other clinical trials within 3 months prior to enrollment
- Need for long-term high-dose glucocorticoid treatment
- Pregnant or lactating women
- Severe, active, uncontrolled endocrine or autoimmune diseases other than type 1 diabetes
- Other investigator-determined reasons making participation unsuitable
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
H
Hao Yin
CONTACT
H
Hao Yin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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