Clinical trial NCT02169531: Ex Vivo Immunotherapy for Hyperglycemia in Type 2 Diabetes Mellitus
Official title: Pilot Study of a Cell-Based Therapy for Treatment of Hyperglycemia in Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Hyperglycemia
Keywords: Diabetes Mellitus Type 2
Hyperglycemia
Immunotherapy
Autologous
Lead sponsor: B & Y Technologies
Sponsor class: INDUSTRY
Collaborators: name: Guangzhou No.12 People's Hospital
name: The 12th People's Hospital of Shenzhen City
First posted: 2014-06-23
Enrollment: 25
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change from Baseline Hemoglobin A1c (HbA1c) at up to 27 weeks.
timeFrame: 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 outcomes:
measure: Change from Baseline Lipid Profile at up to 27 weeks.
timeFrame: 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.
Other outcomes:
measure: Change from Baseline Symptoms at up to 27 weeks.
timeFrame: 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.
Locations:
city: Guangzhou
country: China
facility: The 12th People's Hospital of Guangzhou
state: Guangdong
city: Shenzhen
country: China
facility: The 12th People's Hospital of Shenzhen
state: Guangdong
Study officials:
affiliation: The 12th People's Hospital of Guangzhou.
name: Lingzhen Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: