NCT00021788

Brief Summary

The goal of islet cell transplantation in patients with Type 1 Diabetes Mellitus is to provide constant normal blood glucose levels. This may eliminate the need for insulin altogether or provide a significant reduction in the amount of insulin necessary to maintain constant normal blood glucose levels. This normalization may prevent or slow progression of diabetic complications. Furthermore, the participant may enjoy a healthier lifestyle and a better quality of life. If you meet the initial inclusion criteria for the trial, you must be able to give informed consent personally. Then you will need to participate in an extensive screening process that involves many standard tests and collection of laboratory samples to make sure that the transplant is suitable and safe for you.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jul 2000

Shorter than P25 for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2000

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2001

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2001

Completed
Last Updated

July 9, 2010

Status Verified

July 1, 2010

First QC Date

August 4, 2001

Last Update Submit

July 7, 2010

Conditions

Diabetes Mellitus, Type 1

Keywords

Type I Diabetes MellitusImmunosuppressionIslet Cell TransplantationPercutaneousTranshepaticPortalVein Catheterization

Interventions

islet cell transplantationPROCEDURE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Candidates must be between the ages of 18 and 65
  • Candidates must have had IDDM for at least 5 years and been under physician care for at least 6 months prior to enrollment in trial.
  • Eligible candidates will have poorly controlled insulin-dependent diabetes mellitus (IDDM) and manifest signs and symptoms severe enough to be incapacitating. These symptoms can include episodes of hypoglycemic unawareness (failure to recognize blood glucose levels \< 54 mg/dl) or episodes requiring the assistance of others.
  • Candidates may have poor diabetes control despite intensive insulin therapy (HbA1c \> 8.0%).
  • Creatinine clearance should be \> 60 ml/min)
  • Body Mass Index should be less than 26
  • Women of child-bearing age must have a negative pregnancy test and agree to follow effective contraceptive measures for the duration of the trial.

You may not qualify if:

  • Previous or concurrent organ transplant
  • Previous or concurrent malignancy
  • Untreated proliferative diabetic retinopathy
  • Unstable cardiovascular status, including positive stress echocardiography (if \> age 35)
  • Active infections, including x-ray evidence of pulmonary infection
  • Peptic ulcer disease, gall stones, or portal hypertension
  • Abnormal liver function tests
  • Presence of panel reactive antibodies \> 20%
  • Creatinine clearance \< 60 ml/min
  • HbA1c 12%
  • Serological evidence of HIV, HbsAg, or HCV
  • Anemia (hemoglobin \< 12.0)
  • Any condition or circumstance, including psychogenic factors, that preclude therapeutic compliance or otherwise make it unsafe to undergo an islet cell transplant.
  • PSA \> 4 in males

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami Diabetes Research Institute

Miami, Florida, 33136, United States

Location

Related Publications (2)

  • Alejandro R, Lehmann R, Ricordi C, Kenyon NS, Angelico MC, Burke G, Esquenazi V, Nery J, Betancourt AE, Kong SS, Miller J, Mintz DH. Long-term function (6 years) of islet allografts in type 1 diabetes. Diabetes. 1997 Dec;46(12):1983-9. doi: 10.2337/diab.46.12.1983.

    PMID: 9392484BACKGROUND

  • McAlister VC, Gao Z, Peltekian K, Domingues J, Mahalati K, MacDonald AS. Sirolimus-tacrolimus combination immunosuppression. Lancet. 2000 Jan 29;355(9201):376-7. doi: 10.1016/S0140-6736(99)03882-9.

    PMID: 10665560BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Islets of Langerhans Transplantation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Rodolfo Alejandro, MD

    University of Miami Diabetes Research Institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

August 4, 2001

First Posted

August 6, 2001

Study Start

July 1, 2000

Study Completion

December 1, 2001

Last Updated

July 9, 2010

Record last verified: 2010-07

Locations

US(1)