Islet Transplantation Through an Indwelling Catheter in the Umbilical Vein

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Procedure: umbilical vein catheterization

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Umbilical vein; umbilical vein catheterization

Procedure: umbilical vein catheterization; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
hemorrhage	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
Infection	6 month
Exogenous insulin requirement	1 year
Glucose	1 year
C-peptide	1 year

Collaborators and Investigators

• Sponsor: Fuzhou General Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: January 23, 2015
• First Submitted That Met QC Criteria: February 12, 2015
• First Posted (Estimate): February 20, 2015

Study Record Updates

• Last Update Posted (Estimate): February 20, 2015
• Last Update Submitted That Met QC Criteria: February 12, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: Umbilical-vein