NCT00315627

Brief Summary

The purposes of this study are:

  1. 1.To reverse hyperglycemia and insulin dependency in patients with type 1 diabetes mellitus through islet transplantation utilizing steroid free, calcineurin-inhibitor free immunosuppression.
  2. 2.To assess the long-term function of successful islet transplants in patients with type 1 diabetes mellitus utilizing islets that have undergone a period of culture.
  3. 3.To determine whether the natural history of the microvascular, macrovascular, and neuropathic complications are altered following the successful transplantation of islets.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2005

Longer than P75 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, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 18, 2006

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

May 25, 2017

Completed
Last Updated

May 25, 2017

Status Verified

April 1, 2017

Enrollment Period

8.5 years

First QC Date

April 14, 2006

Results QC Date

December 19, 2016

Last Update Submit

April 18, 2017

Conditions

Type 1 Diabetes Mellitus

Keywords

Islet Transplantation

Outcome Measures

Primary Outcomes (1)

  • Measurement of Glycemic Control by HbA1c and Prevention of Severe Hypoglycemia

    Number of subjects at 1 year with HbA1c \< 6.5% and absence of severe hypoglycemia

    1 year

Secondary Outcomes (4)

  • Islet Allograft Function

    1 year

  • Improvement in Metabolic Control as Evidenced by Hemoglobin A1c < 6.5%

    1 year

  • Elimination of Severe Hypoglycemia

    1 year

  • Restoration of Hypoglycemia Awareness 1 Year After Transplantation

    1 year

Study Arms (1)

islet transplantation

EXPERIMENTAL

Islet Alone Transplantation under Alentuzumab (Campath1H) induction.

Drug: Islet transplantation

Interventions

Islet transplantationDRUG

Islet transplantation

Also known as: islet
islet transplantation

Eligibility Criteria

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

You may qualify if:

  • Potential candidates must have type 1 diabetes mellitus and fulfill one or more of the following:
  • Manifest signs and symptoms that are severe enough to be incapacitating. Incapacitating signs and symptoms include hypoglycemic episodes requiring assistance by others and hypoglycemia unawareness (the inability to recognize low blood glucoses; glucoses \< 54 mg/dl). These patients are at high risk for involvement in accidents (they can lose consciousness or act irrationally), thus causing harm to themselves and/or others.
  • Patients with poor diabetes control (HbA1c \> 8.0% but \< 12%), despite intensive insulin therapy, as defined by: self monitoring of blood glucose ≥ 4 times/day, multiple insulin injections (≥ 3/day) or insulin pump, and close monitoring of blood glucose control by an endocrinologist. These patients can experience acute, rapid hyperglycemia secondary to several stress factors, that can lead to dehydration, disorientation, and in some instances, ketoacidosis.
  • Progressive diabetic complications. These patients with chronically poor glycemic control are at higher risk for the development of a wide variety of complications (retinopathy, neuropathy, nephropathy, and cardiovascular disease) associated with diabetes.

You may not qualify if:

  • Potential candidates will be excluded as per the following criteria:
  • Age \< 18 or \> 65 years
  • Duration of diabetes \< 5 years
  • Do not have a physician that is monitoring diabetes for \> 6 months
  • Body mass index \> 26
  • Weight \> 80 kg
  • Insulin requirement \> 1.0 u/kg/d
  • HbA1c \> 12%
  • Stimulated or basal C-peptide \> 0.3 ng/ml
  • Corrected creatinine clearance \< 60 ml/min
  • Serum creatinine consistently above 1.6 mg/dl
  • Macroalbuminuria (\> 300 mg/24 hours)
  • Anemia (hemoglobin \< 12.0 g/dl for males; \< 11 g/dl for females)
  • Hyperlipidemia (fasting low-density lipoprotein \[LDL\] cholesterol \> 130 mg/dl and/or fasting triglycerides \> 200 mg/dl)
  • Abnormal liver function tests (consistently \> 1.5 x normal range)
  • +26 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes Research Institute

Miami, Florida, 33136, United States

Location

Related Publications (2)

  • Froud T, Baidal DA, Faradji R, Cure P, Mineo D, Selvaggi G, Kenyon NS, Ricordi C, Alejandro R. Islet transplantation with alemtuzumab induction and calcineurin-free maintenance immunosuppression results in improved short- and long-term outcomes. Transplantation. 2008 Dec 27;86(12):1695-701. doi: 10.1097/TP.0b013e31819025e5.

    PMID: 19104407RESULT

  • 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

Results Point of Contact

Title
Dr. Rodolfo Alejandro
Organization
University of Miami Miller School of Medicine
ralejand@med.miami.edu
305 243-5324

Study Officials

  • Rodolfo Alejandro, M.D.

    Diabetes Research Institute - University of Miami

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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

April 14, 2006

First Posted

April 18, 2006

Study Start

July 1, 2005

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

May 25, 2017

Results First Posted

May 25, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)