Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes

Shanghai Changzheng Hospital20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes

Interventions

Autologous regenerative islet transplantation for insulin-dependent diabetes mellitusPROCEDURE

Islet transplantation was completed using percutaneous transhepatic portal vein puncture. After transplantation, rabbit anti human thymocyte immunoglobulin (ATG) or basiliximab was used as induction therapy and low-dose tacrolimus combined with sirolimus or mycophenolate mofetil were used as immunosuppressive maintenance therapy.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Changes in C-peptide

Changes in C-peptide (fasting C-peptide and post-stimulated C-peptide) of patients during the study period since baseline.

Time frame: 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

Changes in insulin (fasting insulin and post-stimulated insulin) of patients during the study period since baseline.

Changes in HbA1c values

Changes in HbA1c values of patients during the study period since baseline.

Secondary Outcomes

Change in the patient's daily insulin unit requirement

Change in the patient's daily insulin unit requirement during the study period.

Time frame: Data will be recorded every day after the surgery until insulin treatment stops during the follow-up time of 12 months.

Number of severe hypoglycemic events

Number of severe hypoglycemic events in patients during the study period.

Time frame: Data will be recorded every week after the surgery during the follow-up time of 12 months.

Changes in glucagon

Changes in glucagon since baseline during the study period.

Central Contacts

Hao Yin

CONTACT

13901677738 yinhaoshanghai@163.com

Data from ClinicalTrials.gov

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