Islet Transplantation Through an Indwelling Catheter in the Umbilical Vein

Phase 1

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Procedure: umbilical vein catheterization

• Registration Number: NCT02367534
• Lead Sponsor: Fuzhou General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2012-12
• Study Completion: 2013-12
• Study First Submitted: 2015-01-23
• Status Verified: 2015-02
• Study First Submitted QC: 2015-02-12
• Last Update Submitted: 2015-02-12
• Study First Posted: 2015-02-20
• Last Update Posted: 2015-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Umbilical vein	umbilical vein catheterization	umbilical vein catheterization

Primary Outcome Measures

Name	Time	Method
hemorrhage	1 month

Secondary Outcome Measures

Name	Time	Method
Infection	6 month
Exogenous insulin requirement	1 year
Glucose	1 year
C-peptide	1 year