NCT00306098

Brief Summary

SPECIFIC AIMS:

  1. 1.To reverse hyperglycemia and insulin dependency in patients with Type 1 Diabetes Mellitus by islet cell transplantation;
  2. 2.To eliminate the incidence of hypoglycemia coma and unawareness in patients with Type 1 Diabetes Mellitus by islet cell transplantation;
  3. 3.To assess long-term safety and function of successful islet cell transplants in patients with Type 1 Diabetes Mellitus;
  4. 4.To determine whether the natural history of the microvascular, macrovascular and neuropathic complications of Diabetes Mellitus are altered following successful transplantation of islet cells; and
  5. 5.To assess the effect of infliximab in preventing early islet destruction, and thereby eliminating the need for a second donor's islet cells.
  6. 6.To assess the effect of etanercept in preventing early islet destruction.
  7. 7.To assess the effect of exenatide to improve islet graft function and survival in subjects that have returned to using exogenous insulin.
  8. 8.To assess the ability of exenatide to improve islet survival at time of transplantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2000

Typical duration 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

December 1, 2000

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 22, 2006

Completed
Last Updated

November 4, 2024

Status Verified

October 1, 2024

Enrollment Period

3.6 years

First QC Date

March 17, 2006

Last Update Submit

October 30, 2024

Conditions

Diabetes Mellitus, Type I

Keywords

Transplantation, Islets of Langerhans

Outcome Measures

Primary Outcomes (1)

  • a1c less than 6.5 without severe hypoglycemia

    number of subjects with a1c less than 6.5 without severe hypoglycemia

    for the duration of islet graft function

Secondary Outcomes (5)

  • partial graft function, as evidenced by baseline C-peptide greater than 0.5 ng/ml

    1 year

  • reduction in insulin requirements in those patients who do not achieve insulin independence

    1 year

  • improvement in metabolic control as evidenced by improvement in: HbA1C (less or equal to 7)

    1 year

  • elimination or reduction in the incidence of hypoglycemic coma or unawareness

    1 year

  • assessment of efficacy of infliximab in preventing early rejection -

    1 year

Study Arms (1)

Islet transplantation

EXPERIMENTAL

Subjects receiving intraportal Islet cell infusion (transplant)

Drug: islets

Interventions

isletsDRUG

Intraportal infusion of islets

Also known as: islet transplantation
Islet transplantation

Eligibility Criteria

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

You may qualify if:

  • Patients between 18 and 65 years of age
  • Patients with type 1 diabetes mellitus for more than 5 years duration
  • One or more of the following:
  • Hypoglycemia unawareness - judged by history of blood sugars \<54 on glucometer without symptoms and/or hypoglycemic episodes requiring assistance from either family, glucagon administration or emergency services
  • Poor diabetes control (HbA1c\>8% or \>2 visits/yr to hospital for treatment of ketoacidosis) despite intensive insulin therapy
  • Progressive complications of type 1 diabetes mellitus
  • Body Mass Index (BMI) ≤26

You may not qualify if:

  • c-peptide \> 0.3ng/ml basal or stimulated;
  • untreated proliferative diabetic retinopathy;
  • HbA1C \>12%;
  • creatinine clearance \<60;
  • serum creatinine consistently \>1.6 mg/dl;
  • macroalbuminuria \>300mg albumin in 24 hours;
  • presence of panel reactive antibodies (PRA) \>20%;
  • previous/concurrent organ transplantation (except previous unsuccessful islet cell transplant;
  • malignancy or previous malignancy (except non-melanomatous skin cancer);
  • x-ray evidence of pulmonary infection;
  • active infections;
  • active peptic ulcer disease, gall stones, hemangioma, or portal hypertension
  • serological evidence of HIV, HbsAg or HCV; serological evidence of active EBV (IgM\>IgG) or EBV negative serology;
  • PPD conversion or positive PPD without historic completion of appropriate prophylactic treatment;
  • abnormal liver function test;
  • +7 more criteria

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 (3)

  • Froud T, Ricordi C, Baidal DA, Hafiz MM, Ponte G, Cure P, Pileggi A, Poggioli R, Ichii H, Khan A, Ferreira JV, Pugliese A, Esquenazi VV, Kenyon NS, Alejandro R. Islet transplantation in type 1 diabetes mellitus using cultured islets and steroid-free immunosuppression: Miami experience. Am J Transplant. 2005 Aug;5(8):2037-46. doi: 10.1111/j.1600-6143.2005.00957.x.

    PMID: 15996257RESULT

  • Faradji RN, Froud T, Messinger S, Monroy K, Pileggi A, Mineo D, Tharavanij T, Mendez AJ, Ricordi C, Alejandro R. Long-term metabolic and hormonal effects of exenatide on islet transplant recipients with allograft dysfunction. Cell Transplant. 2009;18(10):1247-59. doi: 10.3727/096368909X474456.

    PMID: 20003758DERIVED

  • Tharavanij T, Betancourt A, Messinger S, Cure P, Leitao CB, Baidal DA, Froud T, Ricordi C, Alejandro R. Improved long-term health-related quality of life after islet transplantation. Transplantation. 2008 Nov 15;86(9):1161-7. doi: 10.1097/TP.0b013e31818a7f45.

    PMID: 19005394DERIVED

Related Links

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, M.D.

    University of Miami, Diabetes Research Institute

    PRINCIPAL INVESTIGATOR

  • Camillo Ricordi, M.D.

    University of Miami, Diabetes Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

March 17, 2006

First Posted

March 22, 2006

Study Start

December 1, 2000

Primary Completion

July 4, 2004

Study Completion

July 4, 2004

Last Updated

November 4, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)