Islet Transplant for Type 1 or Surgical Diabetes

NCT01606475 | Unknown

• 1 other identifier: 1108M03061
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 1 Diabetes Mellitus; Hypoglycemia; Labile Diabetes; End-stage Renal Disease

Keywords

Islet transplant; Diabetes Mellitus; Hypoglycemia

Interventions

Allogeneic islets of Langerhans BIOLOGICAL

Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight.

Also known as: Islets

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients age 18 to 70 years of age.
• Ability to provide written informed consent.
• Mentally stable and able to comply with the procedures of the study protocol.
• Insulin-dependent diabetes mellitus
• Not otherwise eligible for an existing alloislet transplant protocol for type 1 diabetes mellitus
• Involvement in intensive diabetes management, defined by at least 3 injections daily or insulin pump therapy.
• 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)

You may not qualify if:

• HbA1c \>10%.
• Untreated proliferative diabetic retinopathy.
• Uncontrolled Hypertension (SBP\>160 or DBP\>100)
• For female participants: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study.
• 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.
• Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin.
• 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.
• 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.
• 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%.
• 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.
• History of alcoholism
• Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia; Kidney Failure, Chronic; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bernhard J Hering, M.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2012
• First Posted: May 25, 2012
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

US (1)