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NCT Number: NCT06448052

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Inflammatory Disease Aging Problems Body Weight Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obese Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

DNA International Hospital

Ho Chi Minh City, District 05, 70000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. the expression levels of pro-inflammatory cytokines

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

    Patients peripheral blood withdraws to measure the levels of IL-1α/β (pg/mL), TNF-α/β (pg/mL), IL-6 (pg/mL), IL-11 (pg/mL), IL-18 (pg/mL), IFN-γ (pg/mL) by a suitable kit test.

  2. the expression levels of anti-inflammatory cytokines

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

    Patients peripheral blood withdraws to measure the levels of IL-10 (pg/mL), TGFβ (pg/mL), IL-1 (pg/mL) by a suitable kit test.

  3. the inflammation balance

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

    Calculation of the ratios of pro-inflammatory cytokines to anti-inflammatory cytokines in patients

  4. Effect in diabetes patient

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

    Diabetes patients peripheral blood withdraws to measure the levels of HbA1C (%) by a suitable kit test.

  5. Effect in dislipidemia patient

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

    Dislipidemia patients peripheral blood withdraws to measure the levels of of Cholesterol (mg/dL), Triglyceride (mg/dL), LDLc (mg/dL), HDLc (mg/dL) by a suitable kit test.

  6. Effect in obese patient

    Time frame: Before (day 0), after 90 days, and after 180 days of cell transplantation.

    Obese patients will monitor their weight and calculate their BMI.

Sponsors and collaborators

Lead sponsor

Nguyen Ton Ngoc Huynh

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 7, 2024
Registry last updated
Jun 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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