Clinical trial NCT06448052: Umbilical Cord Mesenchymal Stem Cell for Aging-related Low-grade Inflammation
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Inflammatory Disease
Aging Problems
Obese
Lipid Metabolism Disorders
Diabetes
Keywords: mesenchymal stem cell
low-grade inflammation
Inflammaging
Obese
dislipidemia
diabetes
Lead sponsor: DNA International Hospital
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 72
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: a single-group, open-label, phase I/II clinical trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Adverse effect
timeFrame: From the patients enrolled in the study until 30 days after the study ended.
measure: Serve adverse effect
timeFrame: From the patients enrolled in the study until 30 days after the study ended.
Secondary outcomes:
measure: the expression levels of pro-inflammatory cytokines
timeFrame: Before (day 0), after 90 days, and after 180 days of cell transplantation
measure: the expression levels of anti-inflammatory cytokines
timeFrame: Before (day 0), after 90 days, and after 180 days of cell transplantation
measure: the inflammation balance
timeFrame: Before (day 0), after 90 days, and after 180 days of cell transplantation
measure: Effect in diabetes patient
timeFrame: Before (day 0), after 90 days, and after 180 days of cell transplantation
measure: Effect in dislipidemia patient
timeFrame: Before (day 0), after 90 days, and after 180 days of cell transplantation
measure: Effect in obese patient
timeFrame: Before (day 0), after 90 days, and after 180 days of cell transplantation.
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: DNA International Hospital
state: District 05
Study officials:
affiliation: DNA International General Hospital, Ho Chi Minh City 700000, Vietnam
name: Nguyen TN Huynh, MD
role: PRINCIPAL_INVESTIGATOR
References: