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Pancreas and Islet Cell Transplantation Current Trials

Project Title: Islet Transplantation in Type 1 Diabetes

Purpose: Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation, combined with immunosuppressive medications, for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes (CIT 07).

Inclusion trial criteria:

  • 18-65 years of age
  • Able to comply with study procedures
  • Onset of Type 1 diabetes at less than 40 years of age and insulin dependent for at least 5 years
  • Check daily blood sugar at least three times a day
  • Administer three or more insulin injections each day or use an insulin pump
  • Have at least three visits with your endocrinologist, diabetologist, or diabetes specialist during the past 12 months
  • Have at least one severe hypoglycemic episode in the past 12 months, which is defined as having a blood sugar of less than 54 mg/dl and requiring the assistance of another person to administer an oral carbohydrate, intravenous glucose, or glucagon
  • Reduced awareness of hypoglycemia
  • Body mass index of less than 27 and a weight of greater than 110 lbs
  • Insulin usage of greater than 25 units/day
  • HbA1c of less than 10%

Sponsor:
NIAID, NIDDK

PI:
Dixon Kaufman, MD, PhD

Cost:
May be responsible for anti-rejection medications at some time.

Contact:
Elyse Stuart, RN (312-503-1060)

IRB Project Number: pending

Project Title: Single-Center, Open-Label Clinical Trial of the Efficacy of Peritransplant Administration of Deoxyspergualin in Promoting Restoration of Insulin Independence after Single-Donor Islet Cell Allotransplantation in Non-Uremic Type 1 Diabetic Recipients (CIT 03)

Purpose: Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to assess the safety and efficacy of deoxyspergualin (DSG), an immunosuppressant drug, on post-transplant islet function in people with type 1 diabetes who have not responded to intensive insulin therapy.

Inclusion trial criteria:

  • 18-65 years of age
  • Able to comply with study procedures
  • Onset of Type 1 diabetes at less than 40 years of age and insulin dependent for at least 5 years
  • Check daily blood sugar at least three times a day
  • Administer three or more insulin injections each day or use an insulin pump
  • Have at least three visits with your endocrinologist, diabetologist, or diabetes specialist during the past 12 months
  • Have at least one severe hypoglycemic episode in the past 12 months, which is defined as having a blood sugar of less than 54 mg/dl and requiring the assistance of another person to administer an oral carbohydrate, intravenous glucose, or glucagon
  • Reduced awareness of hypoglycemia
  • Body mass index of less than 27 and a weight of greater than 110 lbs
  • Insulin usage of greater than 25 units/day
  • HbA1c of less than 10%

Sponsor:
NIAID, NIDDK

PI:
Dixon Kaufman, MD, PhD

Cost: May be responsible for anti-rejection medications at some time.

Contact:
Elyse Stuart, RN (312) 503-1060

IRB Project Number: pending

Project Title: Islet Transplantation versus Intensive Insulin Therapy in Type 1 Diabetic Kidney Allograft Recipients (CIT 06)

Purpose: Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to compare the safety and effectiveness of islet transplantation versus intensive insulin treatment (ITT) for treating type 1 diabetes in patients who have received kidney transplants.

Inclusion trial criteria:

  • 18-65 years of age
    • Able to comply with study procedures
  • Onset of Type 1 diabetes at less than 40 years of age and insulin dependent for at least 5 years
  • Received a kidney transplant because of end stage renal disease and have stable function and rejection free for at least 3 months
  • Body mass index of less than 28 or a weight of less than 176 lbs
  • Insulin usage of less than 55 units/day
  • Serum creatinine of less than 1.8 in women and 2.0 in men

Sponsor:
NIAID, NIDDK

PI:
Dixon Kaufman, MD, PhD

Cost: may be responsible for anti-rejection medications at some time.

Contact:
Elyse Stuart, RN(312) 503-1060

IRB Project Number:
0283-022

Project Title: A Pilot Study of Islet Transplantation in Non-Uremic Diabetic Patients

Purpose:
The purpose of this study is to evaluate the safety and effectiveness of islet transplantation utilizing the Edmonton Protocol immunosuppressive regime.

Inclusion trial criteria:

  • Type 1 diabetics without renal dysfunction
  • Hypoglycemic unawareness requiring the assistance of others
  • BMI < 28
  • Insulin usage < 0.7 IU/kg/day

Sponsor:
National Institutes of Health

Primary Investigator:
Dixon Kaufman, MD, PhD

Cost:
May be responsible for anti-infectives, anti-virals and anti-rejection medication.

Contact:
Elyse Stuart, (312) 503-1060

IRB Project Number:
0283-008


Project Title: Advancing Islet Transplants for the Treatment of Type I Diabetes Care

Purpose:
Protocols are currently being finalized. Trials will be multi-center involving both Islet after Kidney Transplantation and Islet Cell Transplant alone.

Inclusion trial criteria:

  • Not yet determined


Sponsor:
National Institutes of Health

Primary Investigator:
Dixon Kaufman, MD, PhD

Cost:
May be responsible for anti-infectives, anti-virals and anti-rejection medication.

Contact:
Elyse Stuart, (312) 503-1060

IRB Project Number:
Not yet determined

 

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