Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes

Naval Military Medical University (Second Military Medical University)

Status

Unknown

Conditions

Diabetes

Treatments

Procedure: Autologous regenerative islet transplantation for insulin-dependent diabetes mellitus

Study type

Interventional

Funder types

Other

Identifiers

NCT05294822

ZXHZ-IIT-01

Details and patient eligibility

About

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 mellitus will be enrolled: poor blood glucose control despite intensive exogenous insulin therapy. The primary endpoint will be defined by the return to normal blood glucose control without insulin at 12 months after transplantation.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Insulin-dependent diabetes mellitus, the specific criteria are (1 of 4-6 is sufficient).
1. Age: 18-70 years old;
2. History of diabetes mellitus >1 year;
3. Insulin-dependent and total daily insulin dose >20 units;
4. Poor blood glucose control despite intensive exogenous insulin therapy (or high blood glucose fluctuation, glycation >8% );
5. Frequent hypoglycemic episodes with unconsciousness; 6) Diabetic nephropathy, patients who need to receive kidney transplantation.

Exclusion criteria

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.