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Pancreatic Islet Transplantation in Patients With Type 1 Diabetes Mellitus


Phase 1/Phase 2
18 Years
60 Years
Open (Enrolling)
Both
Type 1 Diabetes Mellitus

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Trial Information

Pancreatic Islet Transplantation in Patients With Type 1 Diabetes Mellitus


Inclusion Criteria:



- Patients with type 1 diabetes mellitus, who have a stable functioning renal
transplant, are taking the appropriate maintenance immunosuppression and have no
severe health problems that preclude them receiving an islet transplant will be
considered for inclusion.

Exclusion Criteria:

- Have a history of or findings suggestive of unstable diabetic complications (e.g.
active eye disease)

- Active infections (clinically or by laboratory testing)

- History of current malignancy or suspicion of malignancy until properly investigated
and excluded

- Liver or biliary abnormalities

- Unstable cardiovascular disease

- Findings to suggest immunological sensitization or those women who have the potential
to get pregnant and are not using a sufficient method of contraception

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The functional capability of the islet allograft to normalize glucose metabolism in the absence of insulin therapy.

Outcome Time Frame:

Outcome measures will be assessed at protocol prescribed intervals. Long term outcomes assessment will be measured at 5 years post transplant or all evidence of islet function has ceased plus six months.

Safety Issue:

No

Principal Investigator

Adrian H Cotterell, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Virginia Commonwealth University Health System

Authority:

United States: Food and Drug Administration

Study ID:

VCU IRB 4196

NCT ID:

NCT00784966

Start Date:

August 2011

Completion Date:

September 2017

Related Keywords:

  • Type 1 Diabetes Mellitus
  • Islet transplantation
  • Type 1 Diabetes Mellitus
  • Kidney Transplantation
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 1

Name

Location
Virginia Commonwealth University Health System Richmond, Virginia  23298