Patients uncontrolled severe type 1 diabetes
Conditions
Interventions
Clinical islet transplantation for uncontrolled type 1 diabetes patients.
Sponsors
Nagasaki University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age is between 20 and 65 years old at the time of informed consent. 2) Written consent is necessary from the patient. 3) Patient need to obey the protocol. 4) The duration of type 1 DM is at least more than five years. 5) Endogenous insulin secretion is exhausted.(basal C-peptide <0.1 ng/ml) 6) Patient need to receive the basal-bolus insulin therapy. 7) Patient have severe hypoglycemia episodes in the past 12 months 8) Patients need to have datas (Clark Score, HYPO Score, Lability Index). In case of islet transplantation after kidney transplantation, need a consultation and agreement with kidney transplant doctor. Following selection criteria are added. - IAK-1: Passed more than six months after renal transplantation. - IAK-2: Serum creatinine level is less than 1.8mg/dl. The elevation of serum creatinine level is less than 0.2mg/dl during recent 6 months and no remarkable sustained elevation -IAK-3: Oral intake of steroids (prednisone equivalent)is less than 10mg/day.
Exclusion criteria
Exclusion criteria: 1.Body weight is greater than 80kg,or BMI is greater than 25kg/m2. 2.Insulin dose is over 0.8IU/kg/day day, or more than 55U/day. 3/The average value of HbA1C is more than 10.4% in the past year. 4.Patient has untreated proliferative diabetic retinopathy. 5.Systolic blood pressure is above 160mmHg or diastolic blood pressure is over 100mmHg. 6.eGFR is less than 60ml/min/1.73m2 (In case of islet transplantation alone). 7.Urine protein is more than 1g/day. 8.PRA(panel reactive antibody)is above 20%by flow cytometry. 9.Pregnancy test is positive or under the nursing. 10.Patient has following active infections. Hepatitis B or C, HIV, HTLV-I,or acid bacteriosis including tuberculosis. 11.Epstein-Barr IgG antibody is negative. 12.Patient has a history of invasive aspergillosis infection. 13.Patient has a history of cancer. However, completely resected squamous cell carcinoma or basal cell carcinoma of the skin is excluded. 14.Alchoholic or drug addict 15.Hemoglobin level is below normal limit; lymphopenia (<700/&micro;L), neutropenia (<1,500/&micro;L), or thrombocytopenia (platelets <100,000/&micro;L). 16.Patient has a history of factor V deficiency. 17.Coagulation disorder or Anticoagulants are needed after transplantation. 18.Severe heart disease 1)Myocardial infarction in past past 6 months. 2)Ischemic heart failure that is diagnosed by cardiac function test in past one year. 3)Ejection fraction is less than 30%. 19.Liver function test values are sustained high AST,ALT(ALP, or total bilirubin values, continues more than 1.5 times the upper limit of normal) 20.Symptomatic cholelithiasis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of insulin independence The rate of graft survival | — |
Countries
Japan
Contacts
Public ContactShinichirou Ono
Nagasaki University Hospital Department of SURGERY
Outcome results
None listed