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Open-label Investigation of the Safety and Efficacy of DIABECELL in Patients With Type 1 Diabetes Mellitus

NCT01736228 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2015-03-17

No results posted yet for this study

Summary

The purpose of this study is to establish the efficacy and safety of xenotransplantation of DIABECELL \[immunoprotected (alginate-encapsulated) porcine islets\] in patients with established type 1 diabetes mellitus

Conditions

Interventions

DEVICE

DIABECELL

two transplants of 10,000 IEQ/kg DIABECELL (administered at least 12 weeks apart)- total of 20,000 IEQ/kg

Sponsors & Collaborators

  • Living Cell Technologies

    lead INDUSTRY

Principal Investigators

  • Adrián Abalovich · Eva Perón Hospital, San Martín,

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Argentina

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 NCT01736228 on ClinicalTrials.gov