Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes

Last updated: March 15, 2022
Sponsor: Shanghai Changzheng Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus, Type 1

Diabetic Foot Ulcers

Diabetic Gastroparesis

Treatment

N/A

Clinical Study ID

NCT05294822
ZXHZ-IIT-01
  • Ages 18-70
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Insulin-dependent diabetes mellitus, the specific criteria are (1 of 4-6 issufficient).
  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 highblood glucose fluctuation, glycation >8% );
  5. Frequent hypoglycemic episodes with unconsciousness; 6) Diabetic nephropathy,patients who need to receive kidney transplantation.

Exclusion

Exclusion Criteria:

    1. Severe heart disease; 2) Severe mental disorders, poor compliance or alcohol abuse;
  1. 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.

Study Design

Total Participants: 20
Study Start date:
September 30, 2019
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.