Ex Vivo Immunotherapy for Hyperglycemia in Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Diabetes mellitus type 2 is a long-term metabolic disorder that is primarily characterized by insulin resistance, relative insulin deficiency and hyperglycemia. Our hypotheses is that liver would be the primary organ responsible for the metabolic disorder because of some unknown defects, where sugar would not be efficiently converted to glycogen and fat, leading to hyperglycemia. The constant hyperglycemia would keep pressure on beta-cells in the pancreas to eventually exhaust their ability to produce and secret sufficient amount of insulin, exacerbating the disease. The Immunotherapy would enhance the liver functions and correct the abnormal sugar metabolism. In addition, the ex vivo activated cells produce and secret growth factors which would help endothelial cells of blood vessels to reproduce and grow, resulting in reduced arteriosclerosis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: B & Y Technologies
• Collaborators: Guangzhou No.12 People's Hospital; The 12th People's Hospital of Shenzhen City

Criteria

Inclusion Criteria:

• 1. Patients diagnosed with type 2 diabetes mellitus.

• 2. 25 years of age or older. Both sexes.

• 3. HbA1c ≧6.5% for more than 6 months with or without medication.

• 4. Capability of providing informed consent.

Exclusion Criteria:

• 1. History of malignancy.

• 2. Patients with active infections.

• 3. Seropositivity for HIV infection.

• 4. History of myocardial infarction or unstable angina in the previous 3 months.

• 5. Pregnancy or nursing.