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

NCT ID: NCT06448052

Last Updated: 2024-06-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2026-10-30

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.

Conditions

Inflammatory Disease; Aging Problems; Obese; Lipid Metabolism Disorders; Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

UC-MSC transplantation

Participants will receive two intravenous infusions of 100 million umbilical cord mesenchymal stem cells on days 0 and 90.

Group Type: EXPERIMENTAL

umbilical cord mesenchymal stem cell

Intervention Type: BIOLOGICAL

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).

Interventions

umbilical 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).

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nguyen Ton Ngoc Huynh

OTHER

Sponsor Role: lead

Responsible Party

Nguyen Ton Ngoc Huynh

Medical doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nguyen TN Huynh, MD

Role: PRINCIPAL_INVESTIGATOR

DNA International General Hospital, Ho Chi Minh City 700000, Vietnam

Locations

DNA International Hospital

Ho Chi Minh City, District 05, Vietnam

Countries

Vietnam

Other Identifiers

133/QĐ-BYT

Identifier Type: -

Identifier Source: org_study_id