The Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Transplantation in Aging-related Low-grade Inflammation Patients' Pro-inflammatory Cytokines: a Single-group, Open-label, Phase I/II Clinical Trial
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Inflammatory Disease
- Sponsor
- Nguyen Ton Ngoc Huynh
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Serve adverse effect
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
Nguyen Ton Ngoc Huynh
Medical doctor
DNA International Hospital
Eligibility Criteria
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 exclusion criteria was defined according to the Guidelines of the Ministry of Health of Vietnam.
Outcomes
Primary Outcomes
Serve adverse effect
Time Frame: 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.
Adverse effect
Time Frame: 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.
Secondary Outcomes
- the expression levels of anti-inflammatory cytokines(Before (day 0), after 90 days, and after 180 days of cell transplantation)
- Effect in diabetes patient(Before (day 0), after 90 days, and after 180 days of cell transplantation)
- Effect in dislipidemia patient(Before (day 0), after 90 days, and after 180 days of cell transplantation)
- the expression levels of pro-inflammatory cytokines(Before (day 0), after 90 days, and after 180 days of cell transplantation)
- the inflammation balance(Before (day 0), after 90 days, and after 180 days of cell transplantation)
- Effect in obese patient(Before (day 0), after 90 days, and after 180 days of cell transplantation.)