Status:
TERMINATED
Islet Cell Transplantation Alone and CD34+ Donor Bone Marrow Cell Infusion in Type 1 Diabetes Mellitus
Lead Sponsor:
University of Miami
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Diabetes Research Institute Foundation
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
SPECIFIC AIMS: * To reverse hyperglycemia and insulin dependency in patients with Type 1 diabetes mellitus by islet cell transplantation. * To induce a state of donor specific tolerance and eliminate...
Detailed Description
In our current protocol (IRB #2000/0024) the immunosuppressive regimen, comprised of induction with daclizumab and maintenance therapy with sirolimus and tacrolimus, has been combined with the infusio...
Eligibility Criteria
Inclusion
- Patients between 18 and 65 years of age
- Patients with type 1 diabetes mellitus for more than 5 years duration
- One or more of the following:
- Hypoglycemia unawareness - judged by history of blood sugars \<54 on glucometer without symptoms and/or hypoglycemic episodes requiring assistance from either family, glucagon administration or emergency services
- Poor diabetes control (HbA1c\>8% or \>2 visits/yr to hospital for treatment of ketoacidosis) despite intensive insulin therapy
- Progressive complications of type 1 diabetes mellitus
- Body Mass Index (BMI) ≤26
Exclusion
- Untreated proliferative diabetic retinopathy;
- HbA1C \> 12%;
- Insulin requirement \> 1.0u/kg/d
- Stimulated or basal C-peptide \> 0.3 ng/ml
- Creatinine clearance \< 60 and/or serum creatinine consistently \> 1.5mg/dl;
- Macroalbuminuria \> 300mg albumin in 24 hours
- Presence of panel reactive antibodies \> 20%;
- Previous/concurrent organ transplantation (except failed islet cell transplantation);
- Any medical condition requiring chronic use of steroids;
- Malignancy or previous malignancy (except non-melanomatous skin cancer);
- X-ray evidence of pulmonary infection;
- Active infections;
- Positive tuberculin test (unless proof of adequate treatment for latent tuberculosis can be provided)
- Active peptic ulcer disease,
- Gall stones and/or portal hypertension and/or hemangioma on liver ultrasound;
- Serological evidence of HIV, HBV (HBsAg+ and/or HBcAb+ and/or HBsAb+ without evidence of vaccination), HTLV-1 or HCV;
- Negative serology for Epstein Barr virus (EBV) or evidence of acute infection (IgM\>IgG);
- Abnormal liver function test;
- Anemia (hemoglobin \<12.0 g/dl);
- Hyperlipidemia (fasting total cholesterol \>240mg/dl and/or fasting triglycerides \>200mg/dl and/or fasting LDL cholesterol\>140mg/dl);
- Body Mass Index above 26 and/or weight \>80kg;
- Prostate specific antigen (PSA) \> 4 ng/ml;
- Unstable cardiovascular status (including positive stress echocardiography if \>age 35);
- Active alcohol or substance abuse;
- Sexually active females who are not: a) post-menopausal, b) surgically sterile, or c) not using an acceptable method of contraception (oral contraceptives, Norplant, Depo-Provera, and barrier devices are acceptable; condoms used alone are not acceptable);
- Positive pregnancy test or intent for future pregnancy, or male subject's intent to procreate.
- Any condition or any circumstances that makes it unsafe to undergo an islet cell transplant.
- History of previous transplant or previous bone marrow infusion.
- Persistent leucopenia (white blood cell count \<3,000/mm3
Key Trial Info
Start Date :
December 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00315614
Start Date
December 1 2000
End Date
December 1 2010
Last Update
April 4 2017
Active Locations (1)
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1
Diabetes Research Institute
Miami, Florida, United States, 33136