Umbilical Cord Mesenchymal Stem Cell for Aging-related Low-grade Inflammation

Nguyen Ton Ngoc Huynh

Status and phase

Active, not recruiting

Phase 2

Phase 1

Conditions

Obese

Diabetes

Lipid Metabolism Disorders

Aging Problems

Inflammatory Disease

Treatments

Biological: umbilical cord mesenchymal stem cell

Study type

Interventional

Funder types

Other

Identifiers

NCT06448052

133/QĐ-BYT

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 estimated patients

Sex

All

Ages

40 to 64 years old

Volunteers

No Healthy Volunteers

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.