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

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ClinicalTrials.gov Identifier: NCT02169531
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : January 13, 2016
Sponsor:
Collaborators:
Guangzhou No.12 People's Hospital
The 12th People's Hospital of Shenzhen City
Information provided by (Responsible Party):
Demao Yang, 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Hyperglycemia Drug: ex vivo Activated Immune Cells Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of a Cell-Based Therapy for Treatment of Hyperglycemia in Type 2 Diabetes Mellitus
Study Start Date : March 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia

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.




Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169531


Locations
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China, Guangdong
The 12th People's Hospital of Guangzhou
Guangzhou, Guangdong, China, 510620
The 12th People's Hospital of Shenzhen
Shenzhen, Guangdong, China, 518001
Sponsors and Collaborators
B & Y Technologies
Guangzhou No.12 People's Hospital
The 12th People's Hospital of Shenzhen City
Investigators
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Principal Investigator: Lingzhen Chen, MD The 12th People's Hospital of Guangzhou.

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Responsible Party: Demao Yang, Chief Scientist, B & Y Technologies
ClinicalTrials.gov Identifier: NCT02169531     History of Changes
Other Study ID Numbers: DISCOVER 1
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016

Keywords provided by Demao Yang, B & Y Technologies:
Diabetes Mellitus Type 2
Hyperglycemia
Immunotherapy
Autologous

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases