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

January 12, 2016 updated by: Demao Yang, B & Y Technologies

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510620
        • The 12th People's Hospital of Guangzhou
      • Shenzhen, Guangdong, China, 518001
        • The 12th People's Hospital of Shenzhen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline Hemoglobin A1c (HbA1c) at up to 27 weeks.
Time Frame: 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.
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

Outcome Measure
Measure Description
Time Frame
Change from Baseline Lipid Profile at up to 27 weeks.
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Symptoms at up to 27 weeks.
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

B & Y Technologies

Collaborators

Guangzhou No.12 People's Hospital
The 12th People's Hospital of Shenzhen City

Investigators

  • Principal Investigator: Lingzhen Chen, MD, The 12th People's Hospital of Guangzhou.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

June 17, 2014

First Submitted That Met QC Criteria

June 20, 2014

First Posted (Estimate)

June 23, 2014

Study Record Updates

Last Update Posted (Estimate)

January 13, 2016

Last Update Submitted That Met QC Criteria

January 12, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DISCOVER 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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