Ex Vivo Immunotherapy for Hyperglycemia in Type 2 Diabetes Mellitus (DISC)

B & Y Technologies

Status and phase: Completed; Phase 1

Conditions: Hyperglycemia; Type 2 Diabetes Mellitus

Treatments: Drug: ex vivo Activated Immune Cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02169531

DISCOVER 1

Details and patient eligibility

About

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.

Full description

We plan to recruit 20 patients with type 2 diabetes mellitus who suffer hyperglycemia with or without medication. The patients will come to our hospitals for the treatment. A small amount of peripheral blood will be drawn and processed and cultured in our laboratory. The cultured cells (autologous) will be infused intravenously back to patients. Levels of plasma hemoglobin A1c (HbA1c) and other metabolic parameters before and after the therapy will be compared. The therapy is planned to take four weeks for each patient.

Enrollment: 25 patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

ex vivo activated immune cells

Experimental group

Description:

Up to 20 patients diagnosed with type 2 diabetes mellitus and hyperglycemia will be enrolled and assigned to a single treatment group. Patients will give a small amount of peripheral blood and the blood will be processed and cultured in our laboratory. The ex vivo activated autologous blood cells will be infused intravenously back to patients. The treatment will be done twice a week for consecutive 4 weeks. The metabolic parameters of patients before and after the therapy will be compared to determine if the therapy is safe and effective.

Treatment:

Drug: ex vivo Activated Immune Cells