Back to resultsAutologous Regenerative Islet Transplantation for Insulin-dependent Diabetes
Primary Purpose
Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Autologous regenerative islet transplantation for insulin-dependent diabetes mellitus
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
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.
Sites / Locations
- Shanghai Changzheng HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Autologous regenerative islet transplantation for insulin-dependent diabetes mellitus
Arm Description
Outcomes
Primary Outcome Measures
Changes in C-peptide
Changes in C-peptide (fasting C-peptide and post-stimulated C-peptide) of patients during the study period since baseline.
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 Outcome Measures
Change in the patient's daily insulin unit requirement
Change in the patient's daily insulin unit requirement during the study period.
Number of severe hypoglycemic events
Number of severe hypoglycemic events in patients during the study period.
Changes in glucagon
Changes in glucagon since baseline during the study period.
Full Information
NCT ID
NCT05294822
First Posted
March 15, 2022
Last Updated
March 15, 2022
Sponsor
Shanghai Changzheng Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05294822
Brief Title
Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes
Official Title
Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Changzheng Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Autologous regenerative islet transplantation for insulin-dependent diabetes mellitus
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Autologous regenerative islet transplantation for insulin-dependent diabetes mellitus
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in C-peptide
Description
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
Title
Changes in insulin
Description
Changes in insulin (fasting insulin and post-stimulated insulin) 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
Title
Changes in HbA1c values
Description
Changes in HbA1c values 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
Secondary Outcome Measure Information:
Title
Change in the patient's daily insulin unit requirement
Description
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.
Title
Number of severe hypoglycemic events
Description
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.
Title
Changes in glucagon
Description
Changes in glucagon since baseline during the study period.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hao Yin
Phone
13901677738
Email
yinhaoshanghai@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hao Yin
Organizational Affiliation
Shanghai Changzheng Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao Yin
Phone
13901677738
Email
yinhaoshanghai@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes
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