Ex Vivo Immunotherapy for Hyperglycemia in Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus Clinical Trial

— DISC  

Official title:

Pilot Study of a Cell-Based Therapy for Treatment of Hyperglycemia in Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02169531
• Other study ID #: DISCOVER 1
• Status: Completed
• Phase: Phase 1
• First received: June 17, 2014
• Last updated: January 12, 2016
• Start date: March 2014
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: B & Y Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hyperglycemia
• Type 2 Diabetes Mellitus

Intervention

Drug:
• ex vivo Activated Immune Cells
The patients who take medication before the enrollment will be required to reduce at least half the amount of the medication before the treatment. The reduction of the medication will continue during and after the therapy until the levels of plasma hemoglobin A1c (HbA1c) increase to equal or above the levels of the baseline measured before the treatment.

Locations

Country	Name	City	State
China	The 12th People's Hospital of Guangzhou	Guangzhou	Guangdong
China	The 12th People's Hospital of Shenzhen	Shenzhen	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
B & Y Technologies	Guangzhou No.12 People's Hospital, The 12th People's Hospital of Shenzhen City

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from Baseline Symptoms at up to 27 weeks.	The symptoms include insomnia, anorexia, fatigue, frequent trips to the bathroom, unquenchable thirst and blurred vision.	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.	No
Primary	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.	No
Secondary	Change from Baseline Lipid Profile at up to 27 weeks.	Lipid profile includes cholesterol, triglycerides, HDL cholesterol and LDL cholesterol.	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.	No