Islet Transplantation Through an Indwelling Catheter in the Umbilical Vein
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
umbilical vein catheterization
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Male and female patients age 18 to 60 years of age.
- Ability to provide written informed consent.
- Clinical history compatible with type 1 diabetes (T1DM) as defined by the WHO guidelines(2007) on the Diagnosis and classification of Diabetes Mellitus.
- manifest signs and symptoms that are severe enough to be incapacitating.
- Basal C-peptide<0.5ng/mL
- patients with poor diabetes control (HbA1c >7% but <12%)
- progressive diabetic complications.
Exclusion Criteria:
- age <18 years or >60 years
- diabetic history <5 years
- BMI>27
- body weight >80kg
- exogenous insulin requirement >1 unit/kg/day
- severe anemia (male <8g/dl, female <7g/dl)
- low white blood cell count (<3000/dl)
- liver dysfunction
- Symptomatic peptic ulcer disease
- Any malignancy
- Active infection including hepatitis B, hepatitis C, HIV, or TB
- panel reactive antibody >20%
- Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Umbilical vein
Arm Description
umbilical vein catheterization
Outcomes
Primary Outcome Measures
hemorrhage
Secondary Outcome Measures
Infection
Exogenous insulin requirement
Glucose
C-peptide
Full Information
NCT ID
NCT02367534
First Posted
January 23, 2015
Last Updated
February 12, 2015
Sponsor
Fuzhou General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02367534
Brief Title
Islet Transplantation Through an Indwelling Catheter in the Umbilical Vein
Official Title
Islet Transplantation Through an Indwelling Catheter in the Umbilical Vein
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fuzhou General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Islet transplantation is one of the effective and promising options for type 1 diabetes mellitus treatment1-4. The liver is the primary target location for infusion and portal vein catheterization is generally used. Percutaneous transjugular, percutaneous transhepatic, laparoscopically transmesenteric and laparoscopically transumbilical approaches were often utilized to access the portal. Current islet infusion approach via portal vein of liver has various defects. Percutaneous trans-hepatic puncture is risk of possible severe hemorrhage and portal thrombosis. The laparoscopic entry techniques require longer surgical duration and have an increased rate of catheterization failure. Moreover, the catheters were not allowed to indwell for subsequent infusions.
In the current study, the investigators aim to performed open surgery, catheterized the umbilical vein and infused islets into the portal vein. The catheter was indwelled for one month after surgery. Therapeutic effects, surgical parameters and complications were observed to evaluate feasibility and safety.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Umbilical vein
Arm Type
Experimental
Arm Description
umbilical vein catheterization
Intervention Type
Procedure
Intervention Name(s)
umbilical vein catheterization
Intervention Description
A 7 cm incision was made in the middle-right of upper abdominal. The umbilical vein was identified located 4cm beyond umbilicus, which was then half dissected transversely and the atresic venous lumen was recanalized with a common duct probe (3mm-5mm, BAKES). A breakthrough feeling would be sensed after approaching forward for 10-14cm and the umbilical vein was successfully recanalized. The common duct probe was pulled out. A catheter (single lumen central venous catheter, 16-20G, TUOREN, China) was then cannulated for 15cm into left branch of portal vein through umbilical vein. The procedure was observed with Doppler ultrasound (LOGIQ S6, GE).
Primary Outcome Measure Information:
Title
hemorrhage
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Infection
Time Frame
6 month
Title
Exogenous insulin requirement
Time Frame
1 year
Title
Glucose
Time Frame
1 year
Title
C-peptide
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female patients age 18 to 60 years of age.
Ability to provide written informed consent.
Clinical history compatible with type 1 diabetes (T1DM) as defined by the WHO guidelines(2007) on the Diagnosis and classification of Diabetes Mellitus.
manifest signs and symptoms that are severe enough to be incapacitating.
Basal C-peptide<0.5ng/mL
patients with poor diabetes control (HbA1c >7% but <12%)
progressive diabetic complications.
Exclusion Criteria:
age <18 years or >60 years
diabetic history <5 years
BMI>27
body weight >80kg
exogenous insulin requirement >1 unit/kg/day
severe anemia (male <8g/dl, female <7g/dl)
low white blood cell count (<3000/dl)
liver dysfunction
Symptomatic peptic ulcer disease
Any malignancy
Active infection including hepatitis B, hepatitis C, HIV, or TB
panel reactive antibody >20%
Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
12. IPD Sharing Statement
Learn more about this trial
Islet Transplantation Through an Indwelling Catheter in the Umbilical Vein
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