NCT00309231

Brief Summary

The purpose of this study is to perform a series of islet transplants using the Edmonton protocol. Patients with Type I Diabetes and glycemic lability, severe hypoglycemia or hypoglycemic unawareness will undergo transplantation of purified pancreatic islets from cadaveric donors into the portal vein, followed by steroid-free immunosuppression as per the Edmonton protocol (IL-2 antibody induction, sirolimus, low dose tacrolimus-based immunosuppression). The goals of the transplant are to improve glycemic control, stabilize blood sugars and achieve insulin independence.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

March 29, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 31, 2006

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

March 15, 2017

Status Verified

June 1, 2010

First QC Date

March 29, 2006

Last Update Submit

March 13, 2017

Conditions

Type 1 Diabetes

Keywords

diabetes mellitusislet transplantation

Outcome Measures

Primary Outcomes (1)

  • Efficacy

    1 year

Interventions

Islet AllotransplantationPROCEDURE

Clinical islet transplantation using the Edmonton protocol, steroid free immunosuppression using sirolimus and tacrolimus and basilixumab induction therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with type 1 diabetes of at least 5 years duration, with either severe hypoglycemia with unawareness, or severe glycemic lability

You may qualify if:

  • age 18-65 years
  • type 1 diabetes for at least 5 years
  • at least 1 of the following: a) frequent, severe hypoglycaemia b) hypoglycemic unawareness\* c) glycemic lability despite an optimal insulin regimen\*, and failure of intensive insulin therapy as judged by independent endocrinologist

You may not qualify if:

  • obesity (BMI \>28
  • insulin requirements \> 0.7 U/kg/day
  • history of cancer (except basal or squamous skin cancer)
  • unstable, severe, or non-correctable cardiac disease
  • previous organ transplant
  • evidence of sensitization (PRA\>20%)
  • renal dysfunction (macroalbuminuria, renal dialysis)
  • untreated proliferative retinopathy
  • active infection, including hep C, hep B, HIV, TB
  • current cigarette smoking (6 months abstinence required) or substance abuse
  • indication for steroid medications (exception steroid inhalers, topical steroids)
  • indication for anticoagulation (exception aspirin)
  • pregnancy or desire for future pregnancy; breast-feeding
  • major psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre University Campus

London, Ontario, N6A 4L6, Canada

Location

Related Publications (4)

  • Ryan EA, Paty BW, Senior PA, Bigam D, Alfadhli E, Kneteman NM, Lakey JR, Shapiro AM. Five-year follow-up after clinical islet transplantation. Diabetes. 2005 Jul;54(7):2060-9. doi: 10.2337/diabetes.54.7.2060.

    PMID: 15983207BACKGROUND

  • Shapiro AM, Lakey JR, Ryan EA, Korbutt GS, Toth E, Warnock GL, Kneteman NM, Rajotte RV. Islet transplantation in seven patients with type 1 diabetes mellitus using a glucocorticoid-free immunosuppressive regimen. N Engl J Med. 2000 Jul 27;343(4):230-8. doi: 10.1056/NEJM200007273430401.

    PMID: 10911004BACKGROUND

  • Tsujimura T, Kuroda Y, Avila JG, Kin T, Oberholzer J, Shapiro AM, Lakey JR. Influence of pancreas preservation on human islet isolation outcomes: impact of the two-layer method. Transplantation. 2004 Jul 15;78(1):96-100. doi: 10.1097/01.tp.0000133515.37892.d5.

    PMID: 15257045BACKGROUND

  • Lakey JR, Burridge PW, Shapiro AM. Technical aspects of islet preparation and transplantation. Transpl Int. 2003 Sep;16(9):613-32. doi: 10.1007/s00147-003-0651-x. Epub 2003 Aug 19.

    PMID: 12928769BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • William Wall, MD

    Western University, Canada

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 29, 2006

First Posted

March 31, 2006

Study Completion

January 1, 2008

Last Updated

March 15, 2017

Record last verified: 2010-06

Locations

CA(1)