Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes

Study Overview
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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.

Official Title
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Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes

Conditions
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Diabetes

Intervention / Treatment
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* Procedure: Autologous regenerative islet transplantation for insulin-dependent diabetes mellitus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Insulin-dependent diabetes mellitus, the specific criteria are (1 of 4-6 is sufficient). Age: 18-70 years old; History of diabetes mellitus >1 year; Insulin-dependent and total daily insulin dose >20 units; Poor blood glucose control despite intensive exogenous insulin therapy (or high blood glucose fluctuation, glycation >8% ); 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous regenerative islet transplantation for insulin-dependent diabetes mellitus<br> | Procedure: Autologous regenerative islet transplantation for insulin-dependent diabetes mellitus<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in C-peptide | Changes in C-peptide (fasting C-peptide and post-stimulated C-peptide) of patients during the study period since baseline. | 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. | 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 | Changes in HbA1c values of patients during the study period since baseline. | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the patient's daily insulin unit requirement | Change in the patient's daily insulin unit requirement during the study period. | 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. | 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. | 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 |