Ex Vivo Immunotherapy for Hyperglycemia in Type 2 Diabetes Mellitus

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus; Hyperglycemia
• Interventions: Drug: ex vivo Activated Immune Cells

• Registration Number: NCT02169531
• Lead Sponsor: B & Y Technologies

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-06-17
• Study First Submitted QC: 2014-06-20
• Study First Posted: 2014-06-23
• Primary Completion: 2015-06
• Status Verified: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-12
• Last Update Posted: 2016-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ex vivo activated immune cells	ex vivo Activated Immune Cells	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Hemoglobin A1c (HbA1c) at up to 27 weeks.	Point 1: The week (week 1) before the first cell infusion assessed as the baseline; Point 2: The week (week 6) after the last cell infusion; Point 3 and after: every 4 weeks up to 27 weeks.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline Lipid Profile at up to 27 weeks.	Point 1: The week (week 1) before the first cell infusion assessed as the baseline; Point 2: The week (week 6) after the last cell infusion; Point 3 and after: every 4 weeks up to 27 weeks.	Lipid profile includes cholesterol, triglycerides, HDL cholesterol and LDL cholesterol.

Trial Locations

Locations (2)

The 12th People's Hospital of Guangzhou; 🇨🇳 Guangzhou, Guangdong, China

The 12th People's Hospital of Shenzhen; 🇨🇳 Shenzhen, Guangdong, China