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

NCT01739829 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2017-10-20

No results posted yet for this study

Summary

The purpose of this study is to establish the safety and efficacy of xenotransplantation of DIABECELL® in patients with established type 1 diabetes mellitus

Conditions

Interventions

DEVICE

DIABECELL (R)

10,000 IEQ per kg body weight (Total Dose) Administered in two doses: 5,000 IEQ/kg three months apart.

DEVICE

DIABECELL (R)

20,000 IEQ per kg body weight (Total Dose) Administered in two doses: 10,000 IEQ/kg three months apart

Sponsors & Collaborators

  • Diatranz Otsuka Limited

    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
2011-08-31
Primary Completion
2014-06-30
Completion
2014-06-30

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 NCT01739829 on ClinicalTrials.gov