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

NCT06448052 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: 133/QĐ-BYT
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

mesenchymal stem cell; low-grade inflammation; Inflammaging; Obese; dislipidemia; diabetes

Outcome Measures

Primary Outcomes (2)

• Adverse effect

  Adverse effect will be monitored according to Common Terminology Criteria for Adverse Events (CTCAE) V5, NIH.

  From the patients enrolled in the study until 30 days after the study ended.

• Serve adverse effect

  Serve adverse effect will be monitored according to Common Terminology Criteria for Adverse Events (CTCAE) V5, NIH.

  From the patients enrolled in the study until 30 days after the study ended.

Secondary Outcomes (6)

• the expression levels of pro-inflammatory cytokines

  Before (day 0), after 90 days, and after 180 days of cell transplantation

• the expression levels of anti-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 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

Study Arms (1)

UC-MSC transplantation

EXPERIMENTAL

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

Biological: umbilical cord mesenchymal stem cell

Interventions

umbilical cord mesenchymal stem cell 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).

UC-MSC transplantation

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nguyen Ton Ngoc Huynh: lead

Study Sites (1)

DNA International Hospital

Ho Chi Minh City, District 05, 70000, Vietnam

Location

MeSH Terms

Conditions

Obesity; Lipid Metabolism Disorders; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases

Study Officials

• Nguyen TN Huynh, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical doctor

Model Details: a single-group, open-label, phase I/II clinical trial

Study Record Dates

• First Submitted: June 1, 2024
• First Posted: June 7, 2024
• Study Start: November 1, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Anticipate date at the end of 2026
• Access Criteria: For research only

Locations

VN (1)