Islet Transplantation Through an Indwelling Catheter in the Umbilical Vein

900 Hospital of the People's Liberation Army Joint Logistic Support Force

Status and phase

Completed

Phase 2

Phase 1

Conditions

Type 1 Diabetes Mellitus

Treatments

Procedure: umbilical vein catheterization

Study type

Interventional

Funder types

Other

Identifiers

NCT02367534

Umbilical-vein

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.