NCT00260234

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2005

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 1, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

September 9, 2014

Status Verified

September 1, 2014

Enrollment Period

2.1 years

First QC Date

November 28, 2005

Last Update Submit

September 8, 2014

Conditions

Diabetes Mellitus, Type 1

Keywords

Transplantation, Pancreatic IsletsDiabetes Mellitus, Type 1Insulin DependentIslet Transplant

Outcome Measures

Primary Outcomes (1)

  • Safety - will be evaluated by the incidence, grade, and type of adverse events, changes in laboratory parameters, evaluation of the implant site and physical exams.

Secondary Outcomes (13)

  • Efficacy - will be assessed by:

  • Blood glucose levels

  • Daily glycemic excursions

  • Pre-prandial glucose levels

  • Post-prandial glucose levels

  • +8 more secondary outcomes

Study Arms (1)

PEG Islet Cells

EXPERIMENTAL
Biological: Allogeneic Cultured Islet Cells (human); Encapsulated

Interventions

Allogeneic Cultured Islet Cells (human); EncapsulatedBIOLOGICAL
PEG Islet Cells

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or non-pregnant non-lactating female subjects \> 20 years of age
  • Diagnosed with insulin-dependent type I diabetes for at least 20 years
  • BMI less than 28 kg/m2
  • Insulin requirement less than or equal to 0.7 U/kg/day
  • HbA1c greater than or equal to 7.0 %
  • Serum C-peptide concentration less than or equal to 0.5 ng/mL stimulated by an OGTT
  • Female subjects with childbearing potential must have a negative serum pregnancy test prior to enrollment and must agree to use an effective contraceptive method during the study
  • One year of stable diabetes care established in the PI's database without significant changes in insulin requirement or HbA1c or diabetic complication profile

You may not qualify if:

  • Diagnosis of type II diabetes or maturity onset diabetes of youth (MODY)
  • Serum C-peptide greater than 0.5 ng/mL stimulated by OGTT
  • Sustained hypertension greater than or equal to 100 mmHg diastolic and/or greater than or equal to 160 mmHg systolic
  • History of myocardial infarction or current active cardiac disease
  • Current active infection
  • Significant renal dysfunction as indicated by GFR less than 80 mL/min/1.73 m2 and/or urinary albumin greater than 500 µg/mL
  • Significant liver dysfunction as indicated by ALT or AST more than 3X the upper limit of normal
  • Prior whole organ or islet cell transplant
  • Concurrent immunosuppressive therapy
  • Severe gastroparesis, severe peripheral neuropathy, diabetic foot ulcers, or prior amputations due to diabetic complications
  • Any other active autoimmune disease other than autoimmune thyroid disease
  • HIV, HBV or HCV positive status
  • Uncontrolled or untreated proliferative retinopathy
  • Known hypersensitivity or other intolerance to cyclosporine or the inactive ingredients in the product
  • Behavioral activities that place the subject at risk in the opinion of the investigator
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHRISTUS Santa Rosa Transplant Institute

San Antonio, Texas, 78229, United States

Location

Diabetes & Glandular Disease Research Associates, P.A.

San Antonio, Texas, 78229, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Sherwyn Schwartz, M.D.

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

    PRINCIPAL INVESTIGATOR

  • Paraic Mulgrew, M.D.

    CHRISTUS Santa Rosa Transplant Institute, San Antonio, TX

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2005

First Posted

December 1, 2005

Study Start

November 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

September 9, 2014

Record last verified: 2014-09

Locations

US(2)