None listed
Conditions
Interventions
Others(cell therapy) : Islet cells = 2,000 IEQ / kg contained in 25-50 mL of alginate-chitosan capsules of size 600-1000 µm in 1 bag (300 mL) were transplanted once intraperitoneally
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the following criteria shall be met. 1) Patients who fully understand clinical trial and voluntarily agree to participate in clinical trial 2) Age 19 years or older 3) A person with a diabetes mellitus duration of 5 years or more 4) Those who are being treated for insulin 5) One or more of the following criteria (1) Current medicines and insulin that do not control metabolism (2) Failed intensive diabetes treatment: Hemoglobin A1 (HbA1c)> 8.0% (3) Patients receiving more than twice as much inpatient treatment per year due to severe hyperglycemia (4) Hypoglycemia unawareness (Fasting Plasma Glucose (FPG) <54 mg / dL without symptoms) (5) Patients with severe symptomatic hypoglycemia who are unable to live everyday: returning to the emergency room or restoring hypoglycemia with the help of others (6) Patients with secondary complications due to diabetes
Exclusion criteria
Exclusion criteria: Any person subject to any of the following conditions shall not participate in the trial. 1) A person with the following history or surgery / (1) Smoking, drug or alcohol abuse by the tester's judgment within 6 months of screening 2) Those with accompanying accompanying diseases (1) human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), human T-cell lymphoma virus (Human T- cell lymphotrophic virus, HTLV) (Acute infectious diseases can be registered after appropriate treatment according to the judgment of the tester.) (2) patients with acute coronary syndrome within the last 6 months (myocardial infarction, unstable angina) (3) active ulcer is currently being treated 3) pregnant women, lactating women, and pregnant women who have a pregnancy plan during the trial or do not agree to the appropriate method of contraception * * Transplantation of hormonal contraceptives, intrauterine devices or intrauterine systems. Double obstruction (sterile saline and condoms and femoral vaginal septa, vaginal sponge or neck cap), sterilization (vasectomy, bilateral tubal ligation, etc.) 4) Those who have participated in other clinical studies within 12 weeks of screening and have received / treated clinical test medicines or medical devices for clinical tests 5) Persons who are deemed unsuitable for participating in this clinical trial by other examiners, such as psychiatric disorders, serious medical conditions that may impair adherence to clinical trials 6) Those who have an allergic reaction to chitosan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c change after transplantation;The frequency of hypoglycemia after transplantation (eg, a few times a week, a few times a day, a few times a day, etc.) and percentage;Adverse reactions;Vital sign;Laboratory tests (biochemical tests);Infection / inflammation monitoring | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting glucose;Oral glucose tolerance test;C-peptide;Insulin dose;Blood glucose level at hypoglycemia;Graft function test | — |
Countries
Korea, Republic of
Contacts
Public ContactEun Young Lee
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed