Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes

Diabetes Clinical Trial

Official title:

Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05294822
• Other study ID #: ZXHZ-IIT-01
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: December 2023

Study information

• Verified date: March 2022
• Source: Shanghai Changzheng Hospital
• Contact: Hao Yin
• Phone: 13901677738
• Email: yinhaoshanghai[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Shanghai Changzheng Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Changzheng Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.
Secondary	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.
Secondary	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