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

June 6, 2024 updated by: Nguyen Ton Ngoc Huynh

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
    • District 05
      • Ho Chi Minh City, District 05, Vietnam, 70000
        • DNA International Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UC-MSC transplantation
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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the patients enrolled in the study until 30 days after the study ended.
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.
From the patients enrolled in the study until 30 days after the study ended.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before (day 0), after 90 days, and after 180 days of cell transplantation
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.
Before (day 0), after 90 days, and after 180 days of cell transplantation
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
Before (day 0), after 90 days, and after 180 days of cell transplantation
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.
Before (day 0), after 90 days, and after 180 days of cell transplantation
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.
Before (day 0), after 90 days, and after 180 days of cell transplantation
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.
Before (day 0), after 90 days, and after 180 days of cell transplantation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nguyen Ton Ngoc Huynh

Investigators

  • Principal Investigator: Nguyen TN Huynh, MD, DNA International General Hospital, Ho Chi Minh City 700000, Vietnam

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

June 1, 2024

First Submitted That Met QC Criteria

June 6, 2024

First Posted (Actual)

June 7, 2024

Study Record Updates

Last Update Posted (Actual)

June 7, 2024

Last Update Submitted That Met QC Criteria

June 6, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 133/QĐ-BYT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

At the end of the study

IPD Sharing Time Frame

Anticipate date at the end of 2026

IPD Sharing Access Criteria

For research only

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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