Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes

NCT05294822 | Unknown

• 1 other identifier: ZXHZ-IIT-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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.

• Number of severe hypoglycemic events

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

• 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

Study Arms (1)

Autologous regenerative islet transplantation for insulin-dependent diabetes mellitus

EXPERIMENTAL

Procedure: Autologous regenerative islet transplantation for insulin-dependent diabetes mellitus

Interventions

Autologous regenerative islet transplantation for insulin-dependent diabetes mellitus 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.

Autologous regenerative islet transplantation for insulin-dependent diabetes mellitus

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Hao Yin

  Shanghai Changzheng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Yin

CONTACT

13901677738; yinhaoshanghai@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 24, 2022
• Study Start: September 30, 2019
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 24, 2022

Record last verified: 2022-03

Locations

CN (1)