Islet Transplantation Through an Indwelling Catheter in the Umbilical Vein

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Islet Transplantation Through an Indwelling Catheter in the Umbilical Vein

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02367534
• Other study ID #: Umbilical-vein
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 23, 2015
• Last updated: February 12, 2015
• Start date: June 2008
• Est. completion date: December 2013

Study information

• Verified date: February 2015
• Source: Fuzhou General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fuzhou General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemorrhage		1 month	Yes
Secondary	Infection		6 month	Yes
Secondary	Exogenous insulin requirement		1 year	No
Secondary	Glucose		1 year	No
Secondary	C-peptide		1 year	No