Status:
UNKNOWN
Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes
Lead Sponsor:
Shanghai Changzheng Hospital
Conditions:
Diabetes
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This is a single-center, phase IIT clinical trial to evaluate autologous regenerative islet transplantation for insulin-dependent diabetes mellitus. Twenty patients with insulin-dependent diabetes me...
Eligibility Criteria
Inclusion
- Insulin-dependent diabetes mellitus, the specific criteria are (1 of 4-6 is sufficient).
- Age: 18-70 years old;
- History of diabetes mellitus \>1 year;
- Insulin-dependent and total daily insulin dose \>20 units;
- Poor blood glucose control despite intensive exogenous insulin therapy (or high blood glucose fluctuation, glycation \>8% );
- Frequent hypoglycemic episodes with unconsciousness; 6) Diabetic nephropathy, patients who need to receive kidney transplantation.
Exclusion
- 1\) Severe heart disease; 2) Severe mental disorders, poor compliance or alcohol abuse; 3) Active infection or with malignancy; 4) Weight greater than 25% of ideal weight; 5) Evidence of endogenous insulin secretion, such as type 2 diabetes; 6) Smoking; 7) During gestation or preparation for gestation.
Key Trial Info
Start Date :
September 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05294822
Start Date
September 30 2019
End Date
December 1 2023
Last Update
March 24 2022
Active Locations (1)
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1
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China