Islet Cell Transplantation Alone and CD34+ Donor Bone Marrow Cell Infusion in Type 1 Diabetes Mellitus

Stopped early · Phase 2

Conditions studied: Type 1 Diabetes Mellitus

In brief

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 the need for continuous immunosuppressive therapy by simultaneous transplantation of donor bone marrow cells with islets and utilization of the monoclonal antibody Campath-1H for induction of Immunosuppression. * To assess long-term function of successful islet cell transplants in patients with Type 1 diabetes mellitus. * To determine whether the natural history of the microvascular, macrovascular and neuropathic complications are altered following successful transplantation of islet

Key facts

Study ID

NCT00315614

Run by

University of Miami

People needed

3

Starts

2000-12-01

Expected to finish

2010-12-01

Last updated by the study team

2017-04-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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);

Where it is running

• Diabetes Research Institute — Miami, Florida, United States

Full record on ClinicalTrials.gov

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