Ex Vivo Immunotherapy for Hyperglycemia in Type 2 Diabetes Mellitus (DISC)
12 januari 2016 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
25
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Guangdong
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Guangzhou, Guangdong, Kina, 510620
- The 12th People's Hospital of Guangzhou
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Shenzhen, Guangdong, Kina, 518001
- The 12th People's Hospital of Shenzhen
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
25 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Change from Baseline Hemoglobin A1c (HbA1c) at up to 27 weeks.
Tidsram: 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.
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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.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change from Baseline Lipid Profile at up to 27 weeks.
Tidsram: 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.
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Lipid profile includes cholesterol, triglycerides, HDL cholesterol and LDL cholesterol.
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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.
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change from Baseline Symptoms at up to 27 weeks.
Tidsram: 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.
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The symptoms include insomnia, anorexia, fatigue, frequent trips to the bathroom, unquenchable thirst and blurred vision.
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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.
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Lingzhen Chen, MD, The 12th People's Hospital of Guangzhou.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2014
Primärt slutförande (Faktisk)
1 juni 2015
Avslutad studie (Faktisk)
1 januari 2016
Studieregistreringsdatum
Först inskickad
17 juni 2014
Först inskickad som uppfyllde QC-kriterierna
20 juni 2014
Första postat (Uppskatta)
23 juni 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
13 januari 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 januari 2016
Senast verifierad
1 januari 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- DISCOVER 1
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