Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes

Not Applicable

• Conditions: Diabetes
• Interventions: Procedure: Autologous regenerative islet transplantation for insulin-dependent diabetes mellitus

• Registration Number: NCT05294822
• Lead Sponsor: Shanghai Changzheng Hospital

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-30
• Status Verified: 2022-03
• Study First Submitted: 2022-03-15
• Study First Submitted QC: 2022-03-15
• Last Update Submitted: 2022-03-15
• Study First Posted: 2022-03-24
• Last Update Posted: 2022-03-24
• Primary Completion: 2023-06
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous regenerative islet transplantation for insulin-dependent diabetes mellitus	Autologous regenerative islet transplantation for insulin-dependent diabetes mellitus	-

Primary Outcome Measures

Name	Time	Method
Changes in HbA1c values	before surgery, once a week for the first month after surgery, once a month between the second and six month after surgery, and once every 3 months afterwards, with the follow-up time of 12 months in total	Changes in HbA1c values of patients during the study period since baseline.
Changes in C-peptide	before surgery, once a week for the first month after surgery, once a month between the second and six month after surgery, and once every 3 months afterwards, with the follow-up time of 12 months in total	Changes in C-peptide (fasting C-peptide and post-stimulated C-peptide) of patients during the study period since baseline.
Changes in insulin	before surgery, once a week for the first month after surgery, once a month between the second and six month after surgery, and once every 3 months afterwards, with the follow-up time of 12 months in total	Changes in insulin (fasting insulin and post-stimulated insulin) of patients during the study period since baseline.

Secondary Outcome Measures

Name	Time	Method
Change in the patient's daily insulin unit requirement	Data will be recorded every day after the surgery until insulin treatment stops during the follow-up time of 12 months.	Change in the patient's daily insulin unit requirement during the study period.
Changes in glucagon	before surgery, once a week for the first month after surgery, once a month between the second and six month after surgery, and once every 3 months afterwards, with the follow-up time of 12 months in total	Changes in glucagon since baseline during the study period.
Number of severe hypoglycemic events	Data will be recorded every week after the surgery during the follow-up time of 12 months.	Number of severe hypoglycemic events in patients during the study period.

Trial Locations

Locations (1)

Shanghai Changzheng Hospital; 🇨🇳 Shanghai, Shanghai, China