Recruiting
Phase 1
Phase 2

Islet Transplant

Sponsor:

Kenneth Brayman, MD

Code:

NCT03698396

Conditions

Diabetes Mellitus, Type 1

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Allogenic Islet Cell Transplantation

Study Details

Brief summary:

The primary objective of this study is to demonstrate the safety of allogenic islet transplantation in type 1 diabetic patients performed at the University of Virginia.

The purpose is to demonstrate that islet transplantation can be performed safely and reliably achieves better glycemic control than state-of-the-art insulin treatment in management of type 1 diabetic patients with brittle control and a history of severe hypoglycemic episodes with hypoglycemia unawareness.

Conditions

Diabetes Mellitus, Type 1

Study ID

NCT03698396

Start date

Aug 1, 2019

Status verified date

Jul, 2020

Completion date

Dec 1, 2023

Anticipated

Primary completion date

Nov 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • At least 1 episode of severe hypoglycemia in the past 3 years
  • Reduced awareness of hypoglycemia
  • Must be a qualified candidate for pancreas transplant

Exclusion Criteria:

  • Diagnosis of co-existing cardiac diseased (ie, recent myocardial infarction within 6 months or angiographic evidence of non-correctable coronary artery disease or evidence of ischemia on functional cardiac exam
  • Active alcohol or substance abuse
  • Psychiatric disorder this is unstable or uncontrolled on current medication
  • History of non-compliance
  • Active infection including hepatitis C, hepatitis B, HIV
  • History of or active Tuberculosis
  • Any history of cancer, except skin cancer
  • History of stroke within past 6 months
  • BMI > 27 kg/m2
  • C-peptide fasting response to glucagon stimulation
  • Inability to provide informed consent
  • Creatinine Clearance < 60 ml/min
  • Macroalbuminuria
  • Baseline Hb <12 gm/dL
  • Baseline liver function test outside normal ranges
  • History of untreated proliferative retinopathy
  • Positive pregnancy test or male subjects intent to procreate while on study
  • Previous transplant (except islet transplant)
  • Insulin requirement of > 0.7 IU/kg/day
  • HbA1c . 12%
  • Hyperlipidemia
  • Under treatment for medical condition requiring chronic use of steroids
  • Use of coumadin or other antiplatelet therapy
  • History of Factor V deficiency
  • History of Addison's disease
  • Allergic to radiographic contrast material
  • Symptomatic cholecystolithiasis
  • Acute on chronic pancreatitis
  • Symptomatic peptic ulcer disease
  • Severe unremitting diarrhea, vomiting or other gastrointestinal disorders that could interfere with the ability to absorb oral medications
  • Treatment with antidiabetic medication other than insulin within 4 weeks of enrollment
  • Use of any investigational drug or device within 4 weeks of enrollment
  • Received a live attenuated vaccine within 2 months of listing
  • Active coagulopathy

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Allogenic Islet Cell Transplantation

Transplantation of allogenic islet cell will be given to eligible patients, up to three times during the study, using cell quantities based on body weight.

Interventions

Allogenic Islet Cell Transplantation

Transplantation of allogenic islet cells will be given to eligible patients, up to three times during the study, using cell quantities based on body weight.

Primary outcome measure

  • Incidence of procedure related adverse events [ Time Frame: within 1 year of transplant ]

Central Contacts and Locations

Central contacts

Robin L Kelly, RN

434-924-5529rlk5a@virginia.edu

Robin Kelly, RN

434-924-5529rlk5a@virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Robin Kelly, RN

434-924-5529rlk5a@virginia.edu

Principal Investigator:

KEnneth Brayman, MD

More Information

Sponsor

Kenneth Brayman, MD

Last update posted

Jul 30, 2020

Last verified

Jul, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kenneth Brayman, MD on 2020-07-30.