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Open-label Investigation of the Safety and Effectiveness of DIABECELL(R) in Patients With Type I Diabetes Mellitus

NCT00940173 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-10-20

No results posted yet for this study

Summary

The purpose of this study is to establish the safety of xenotransplantation of DIABECELL(R)\[immunoprotected (alginate-encapsulated) porcine islets\] in patients with established type 1 diabetes mellitus, and to establish preliminary evidence of the efficacy of DIABECELL(R), as measured by a reduction in serial hemoglobin A1c (HbA1C) levels.

Conditions

Interventions

DEVICE

DIABECELL(R)

10,000 IEQ/kg injected into the peritoneal cavity via laparoscopy

DEVICE

DIABECELL(R)

15,000 IEQ/kg injected into the peritoneal cavity via laparoscopy

DEVICE

DIABECELL(R)

20,000 IEQ/kg injected into the peritoneal cavity via laparoscopy

DEVICE

DIABECELL(R)

5,000 IEQ/kg injected into the peritoneal cavity via laparoscopy

Sponsors & Collaborators

  • Diatranz Otsuka Limited

    lead INDUSTRY

Principal Investigators

  • John Baker, MB ChB · Centre for Clinical Research and Effective Practice

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00940173 on ClinicalTrials.gov