Islet Transplant for Type 1 or Surgical Diabetes (EXAX)

Expanded access is currently available for this treatment.
Verified June 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01606475
First received: May 23, 2012
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to evaluate the safety and efficacy of islet transplants from human cadaver donors into type 1 or surgical diabetes mellitus patients who experience frequent acute or advanced chronic complications but do not qualify for other islet transplant trials. Under this protocol, patients may receive intraportal alloislet transplant under one of the following scenarios:

  1. islet transplant alone
  2. simultaneous islet-kidney transplant, or 3)islet after kidney transplant.

Condition Intervention
Type 1 Diabetes Mellitus
Hypoglycemia
Labile Diabetes
End-stage Renal Disease
Biological: Allogeneic islets of Langerhans

Study Type: Expanded Access     What is Expanded Access?
Official Title: Human Alloislet Transplant for Type 1 or Surgical Diabetes Mellitus With Complications

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Intervention Details:
    Biological: Allogeneic islets of Langerhans
    Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight.
    Other Name: Islets
Detailed Description:

The overall objective of this study is to evaluate the efficacy of islet allotransplants for labile diabetes mellitus in patients who do not meet standard inclusion/exclusion criteria for any other islet transplant trials in the US and are not good candidates for a pancreas transplant. We expect that this will include patients who have surgical diabetes (total pancreatectomy) rather than type 1 diabetes, patients who are highly sensitized (PRA>20%), and patients who have had prior failed pancreas transplantation. These patients may have equally severe hypoglycemia, glucose lability, and/or severe microvascular complications, but are excluded from standard islet transplant trials currently available in the U.S.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  1. Male and female patients age 18 to 70 years of age.
  2. Ability to provide written informed consent.
  3. Mentally stable and able to comply with the procedures of the study protocol.
  4. Insulin-dependent diabetes mellitus
  5. Not otherwise eligible for an existing alloislet transplant protocol for type 1 diabetes mellitus
  6. Involvement in intensive diabetes management, defined by at least 3 injections daily or insulin pump therapy.
  7. Meets at least one of the following criteria despite intensive efforts made in close cooperation with their diabetic care team:

    • Significant hypoglycemia unawareness or glycemic lability on conventional insulin therapy, as evidenced by at least one of the following at screening:
    • Clarke score > 4
    • HYPO score >90th percentile (1047)
    • Lability index (LI) >90th percentile (433 mM2/h/wk)
    • A composite of a Clarke score of 4 or more and a HYPO score greater than or equal to the 75th percentile (423) and a LI greater than of equal to the 75th percentile (329)
    • Progressive secondary complications as defined by end-stage renal disease necessitating dialysis or renal transplantation (eligible for islet after kidney or simultaneous islet kidney transplant) AND islet transplant appears to provide a more satisfactory benefit to risk ratio compared to pancreas transplantation (eg high surgical risk)

Exclusion Criteria:

  1. HbA1c >10%.
  2. Untreated proliferative diabetic retinopathy.
  3. Uncontrolled Hypertension (SBP>160 or DBP>100)
  4. For female participants: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study.
  5. Active infection including hepatitis B, hepatitis C, HIV, or TB as determined by a positive skin test or clinical presentation, or under treatment for suspected TB.
  6. Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin.
  7. Receiving treatment for a medical condition requiring chronic use of systemic steroids, except for use of prednisone <5 mg per day for kidney transplant recipients or physiologic hydrocortisone replacement.
  8. Persistent elevation of liver function tests at the time of study entry. Persistent SGOT (AST), SGPT (ALT), Alk Phos or total bilirubin, with values >1.5 times normal upper limits will exclude a patient.
  9. Severe co-existing cardiac disease, characterized by any one of these conditions:

    • recent myocardial infarction (within past 6 months).
    • evidence of ischemia on functional cardiac exam within the last year.
    • left ventricular ejection fraction <30%.
  10. If diabetes is secondary to total pancreatectomy, participants will be considered only if >1 year out from surgery, medically stable, without severe issues with bowel function or pain management that may interfere with safe completion of the trial.
  11. History of alcoholism
  12. Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01606475

Contacts
Contact: Jayne Pederson 612-624-8402 peder059@umn.edu

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Contact: Jayne Pederson    612-624-8402    peder059@umn.edu   
Principal Investigator: Bernhard J Hering, M.D.         
Sub-Investigator: Melena Bellin, M.D.         
Sub-Investigator: David ER Sutherland, M.D., Ph.D.         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Bernhard J Hering, M.D. University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01606475     History of Changes
Other Study ID Numbers: 1108M03061
Study First Received: May 23, 2012
Last Updated: June 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Islet transplant
Diabetes Mellitus
Hypoglycemia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Kidney Diseases
Kidney Failure, Chronic
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on August 28, 2014