Type 2 Diabetes MellitusPhase 1DISCNCT02169531
Ex Vivo Immunotherapy for Hyperglycemia in Type 2 Diabetes Mellitus
A Phase 1 study testing ex vivo Activated Immune Cells in people with Type 2 Diabetes Mellitus and Hyperglycemia, run by B & Y Technologies at 2 sites in China.
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… Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Hyperglycemia
- What is being tested?
- ex vivo Activated Immune Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesChina
- Study dates
- Mar 2014to Jan 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
The 12th People's Hospital of Guangzhou
Guangzhou, Guangdong, 510620
The 12th People's Hospital of Shenzhen
Shenzhen, Guangdong, 518001
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus, Hyperglycemia
- Being tested
- ex vivo Activated Immune Cells
- Keywords
- Diabetes Mellitus Type 2, Hyperglycemia, Immunotherapy, Autologous
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ex vivo Activated Immune CellsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| ex vivo activated immune cells | Experimental | 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. Receives: Drug: ex vivo Activated Immune Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Hemoglobin A1c (HbA1c) at up to 27 weeks.
Measured: 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.
Lipid profile includes cholesterol, triglycerides, HDL cholesterol and LDL cholesterol.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- B & Y Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guangzhou No.12 People's Hospital, The 12th People's Hospital of Shenzhen City
- Responsible party
- Principal investigator, Demao Yang, B & Y Technologies
- Investigators
- Lingzhen Chen, MD, Principal investigator, The 12th People's Hospital of Guangzhou.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169531
- Sponsor's protocol ID
- DISCOVER 1
- Acronym
- DISC
- Status last verified
- Jan 2016
- First submitted
- 17 Jun 2014
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Cell-Based Therapy for Treatment of Hyperglycemia in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02169531
- Acronym / sponsor ID
- DISC / DISCOVER 1
- Conditions
- Type 2 Diabetes Mellitus, Hyperglycemia
- Keywords
- Diabetes Mellitus Type 2, Hyperglycemia, Immunotherapy, Autologous
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- B & Y TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- Guangzhou No.12 People's Hospital, The 12th People's Hospital of Shenzhen City
- Study start
- Mar 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ex vivo activated immune cells | Experimental | Drug: ex vivo Activated Immune CellsUp 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ex vivo Activated Immune CellsThe 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. | Drug | ex vivo activated immune cells |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lingzhen Chen, MD principal investigator
The 12th People's Hospital of Guangzhou.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ex vivo Activated Immune Cells in people with Type 2 Diabetes Mellitus and Hyperglycemia, run by B & Y Technologies at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2016.