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
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus Hyperglycemia||Drug: ex vivo Activated Immune Cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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. ]
- 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.
- 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.
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
|The 12th People's Hospital of Guangzhou|
|Guangzhou, Guangdong, China, 510620|
|The 12th People's Hospital of Shenzhen|
|Shenzhen, Guangdong, China, 518001|
|Principal Investigator:||Lingzhen Chen, MD||The 12th People's Hospital of Guangzhou.|