NCT00073281

Brief Summary

This protocol will test whether Type 1 diabetes (T1DM) can be reversed in patients with stable renal allografts by islet transplantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2003

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2003

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
Last Updated

January 15, 2010

Status Verified

January 1, 2010

First QC Date

November 18, 2003

Last Update Submit

January 14, 2010

Conditions

Diabetes Mellitus, Type 1

Keywords

diabetesautoimmunity

Interventions

Islet transplantationPROCEDURE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* Patients with type 1 diabetes with stable renal allografts

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Columbia Presbyterian Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes MellitusAutoimmune Diseases

Interventions

Islets of Langerhans Transplantation

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Cell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsEndocrine Surgical ProceduresSurgical Procedures, OperativeTransplantation

Study Officials

  • Mark Hardy, MD

    Columbia Presbyterian Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

November 18, 2003

First Posted

November 20, 2003

Study Start

August 1, 2003

Study Completion

December 1, 2004

Last Updated

January 15, 2010

Record last verified: 2010-01

Locations

US(1)