Ex Vivo Immunotherapy for Hyperglycemia in Type 2 Diabetes Mellitus
DISC
Pilot Study of a Cell-Based Therapy for Treatment of Hyperglycemia in Type 2 Diabetes Mellitus
1 other identifier
interventional
25
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 type-2-diabetes-mellitus
Started Mar 2014
Longer than P75 for phase_1 type-2-diabetes-mellitus
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 17, 2014
CompletedFirst Posted
Study publicly available on registry
June 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedJanuary 13, 2016
January 1, 2016
1.3 years
June 17, 2014
January 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (1)
Change from Baseline Lipid Profile 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.
Other Outcomes (1)
Change from Baseline Symptoms 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.
Study Arms (1)
ex vivo activated immune cells
EXPERIMENTALUp 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- \. Patients diagnosed with type 2 diabetes mellitus.
- \. 25 years of age or older. Both sexes.
- \. HbA1c ≧6.5% for more than 6 months with or without medication.
- \. Capability of providing informed consent.
You may not qualify if:
- \. History of malignancy.
- \. Patients with active infections.
- \. Seropositivity for HIV infection.
- \. History of myocardial infarction or unstable angina in the previous 3 months.
- \. Pregnancy or nursing.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- B & Y Technologieslead
- Guangzhou No.12 People's Hospitalcollaborator
- The 12th People's Hospital of Shenzhen Citycollaborator
Study Sites (2)
The 12th People's Hospital of Guangzhou
Guangzhou, Guangdong, 510620, China
The 12th People's Hospital of Shenzhen
Shenzhen, Guangdong, 518001, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lingzhen Chen, MD
The 12th People's Hospital of Guangzhou.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Scientist
Study Record Dates
First Submitted
June 17, 2014
First Posted
June 23, 2014
Study Start
March 1, 2014
Primary Completion
June 1, 2015
Study Completion
January 1, 2016
Last Updated
January 13, 2016
Record last verified: 2016-01