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Safety and Efficacy of PEG-Encapsulated Islet Allografts Implanted in Type I Diabetic Recipients

NCT00260234 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2014-09-09

No results posted yet for this study

Summary

Insulin dependent Type I diabetics require daily insulin therapy to normalize blood glucose but may have difficulty with significant glycemic excursions and hypoglycemic episodes and crises. Islet cell transplantation can provide relief from daily insulin therapy, normalize blood glucose and reduce or eliminate short and long-term diabetes-related complications. "PEG-Encapsulated Islet Allografts" is a new islet transplant product under development that does not require the ongoing use of immunosuppressive drugs after the implant. This study will test the safety and efficacy of PEG-Encapsulated Islet Allografts in the treatment of Type I diabetes and provide functional outcome measurements.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

BIOLOGICAL

Allogeneic Cultured Islet Cells (human); Encapsulated

Sponsors & Collaborators

  • Diabetes & Glandular Disease Research Associates, P.A., San Antonio, TX

    collaborator UNKNOWN

  • CHRISTUS Health

    collaborator OTHER

  • Novocell

    lead INDUSTRY

Principal Investigators

  • Sherwyn Schwartz, M.D. · Diabetes & Glandular Disease Research Associates, P.A., San Antonio, TX

  • Paraic Mulgrew, M.D. · CHRISTUS Santa Rosa Transplant Institute, San Antonio, TX

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • United States

Study Locations

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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 NCT00260234 on ClinicalTrials.gov