Inflammatory Disease, Aging Problems, Obese, Lipid Metabolism Disorders, Diabetes
Conditions
Keywords
mesenchymal stem cell, low-grade inflammation, Inflammaging, Obese, dislipidemia, diabetes
Brief summary
The goal of this single-group, open-label, phase I/II clinical trial is to evaluate the safety and efficacy of the transplantation of umbilical cord mesenchymal stem cells in aging-related low-grade inflammation patients' pro-inflammatory cytokines. The main questions to answer are: * Is the transplantation of umbilical cord mesenchymal stem cells in aging-related low-grade inflammation patients safe? * Comparison of the expression levels of pro-inflammatory cytokines (IL-1α/β, TNF-α/β, IL-6, IL-11, IL-18, IFN-γ) in the patient's blood before (day 0), after 90 days, and after 180 days of cell transplantation. * Comparison of the expression levels of anti-inflammatory cytokines (IL-10, TGFβ, IL-1) in the patient's blood before (day 0), after 90 days, and after 180 days of cell transplantation. * Comparison of the inflammation balance by the ratios of pro-inflammatory cytokines to anti-inflammatory cytokines in the patient's blood before (day 0), after 90 days, and after 180 days of cell transplantation. * Comparison of the HbA1C index in the diabetes patient's blood before (day 0), after 90 days, and after 180 days of cell transplantation. * Comparision of the indices of Cholesterol, Triglyceride, LDLc, HDLc in the dislipidemia patient's blood before (day 0), after 90 days, and after 180 days of cell transplantation. * Comparison of the BMI in the obese patient's blood before (day 0), after 90 days, and after 180 days of cell transplantation. * Determination of adverse effect frequency in the patients before (day 0), during, after 90 days, and after 180 days of cell transplatation. Participants will receive two intravenous infusions of 100 million umbilical cord mesenchymal stem cells on days 0 and 90. The patient will be monitored for safety and measured as per the study protocol until day 180.
Detailed description
Inflamm-aging is associated with the rate of aging and is significantly related to diseases such as Alzheimer's disease, Parkinson's disease, atherosclerosis, heart disease, and age-related degenerative diseases such as type II diabetes and osteoporosis. This study aims to evaluate the safety and efficiency of Umbilical cord mesenchymal stem cell (UC-MSC) transplantation in aging-related low-grade inflammation patients. This study is a single-group, open-label, phase I clinical trial in which patients treated with 2 infusions (100 million cells i.v) of UC-MSC were evaluated in inflamm-aging patients who concurrently had highly proinflammatory cytokines and 2 of the following 3 diseases: diabetes, dyslipidemia, and obesity. The treatment effects were evaluated based on plasma cytokines related to inflammation, HbA1C index in diabetes patients, the levels of of Cholesterol, Triglyceride, LDLc, HDLc in dislipidemia patients, BMI in obese patients. The patient will be monitored for safety during the study protocol according to the Common Terminology Criteria for Adverse Events (CTCAE) V5, NIH. The assessment of the effectiveness at days 0, 90, and 180 after cell transplantation.
Interventions
BIOLOGICALumbilical cord mesenchymal stem cell
A total of 100 million single cells were suspended in 0.9% sterile saline solution and given intravenously at a 5-ml/min rate for 45 min. All patients will get two intravenous autologous infusions on days 0 (D0) and 90 (D90).
Sponsors
Nguyen Ton Ngoc Huynh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
a single-group, open-label, phase I/II clinical trial
Eligibility
Sex/Gender
ALL
Age
40 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Male or female aged 40-64 years * TNF-α index \> 11 pg/ml and IL6 index \> 1.23 pg/ml * Possesion of at least two of the following three comorbidities: diabetes, dyslipidemia, and obesity * Stable use of medications for the previous 3 months to treat the previously mentioned comorbidities * Agreement to participate in the study and to comply with the research examination and evaluation process
Exclusion criteria
* Patients with coagulopathy * History of or current severe heart failure * Acute respiratory disease at the time of screening * Patients with cancer or other acute illness requiring treatment * History of allergy to anesthetics and antibiotics * Currently/planning to participate in another clinical trial during the study period * Possessing additional conditions or circumstances that make it difficult to provide treatment, according to the researcher Pathology of disease in the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse effect | From the patients enrolled in the study until 30 days after the study ended. | Adverse effect will be monitored according to Common Terminology Criteria for Adverse Events (CTCAE) V5, NIH. |
| Serve adverse effect | From the patients enrolled in the study until 30 days after the study ended. | Serve adverse effect will be monitored according to Common Terminology Criteria for Adverse Events (CTCAE) V5, NIH. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the inflammation balance | Before (day 0), after 90 days, and after 180 days of cell transplantation | Calculation of the ratios of pro-inflammatory cytokines to anti-inflammatory cytokines in patients |
| Effect in diabetes patient | Before (day 0), after 90 days, and after 180 days of cell transplantation | Diabetes patients peripheral blood withdraws to measure the levels of HbA1C (%) by a suitable kit test. |
| the expression levels of pro-inflammatory cytokines | Before (day 0), after 90 days, and after 180 days of cell transplantation | Patients peripheral blood withdraws to measure the levels of IL-1α/β (pg/mL), TNF-α/β (pg/mL), IL-6 (pg/mL), IL-11 (pg/mL), IL-18 (pg/mL), IFN-γ (pg/mL) by a suitable kit test. |
| Effect in obese patient | Before (day 0), after 90 days, and after 180 days of cell transplantation. | Obese patients will monitor their weight and calculate their BMI. |
| Effect in dislipidemia patient | Before (day 0), after 90 days, and after 180 days of cell transplantation | Dislipidemia patients peripheral blood withdraws to measure the levels of of Cholesterol (mg/dL), Triglyceride (mg/dL), LDLc (mg/dL), HDLc (mg/dL) by a suitable kit test. |
| the expression levels of anti-inflammatory cytokines | Before (day 0), after 90 days, and after 180 days of cell transplantation | Patients peripheral blood withdraws to measure the levels of IL-10 (pg/mL), TGFβ (pg/mL), IL-1 (pg/mL) by a suitable kit test. |
Countries
Vietnam
Outcome results
None listed