Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Autologous regenerative islet transplantation for insulin-dependent diabetes mellitus

Group Type EXPERIMENTAL

Autologous regenerative islet transplantation for insulin-dependent diabetes mellitus

Intervention Type PROCEDURE

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.

Interventions

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Autologous regenerative islet transplantation for insulin-dependent diabetes mellitus

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No