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Evaluating the Safety and Efficacy of Autologous Adipose Tissue-derived Mesenchymal Stem Cell Transplantation on Proinflammatory Cytokines and Anti-inflammatory Cytokines on Ageing-related Low-grade Inflammation Patients.

Primary Purpose

Aging Problems, Aging, Chronic Inflammation

Status
Recruiting
Phase
Phase 1
Locations
Vietnam
Study Type
Interventional
Intervention
autologous adipose-derived mesenchymal stem cell transplantation
Sponsored by
DNA International Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aging Problems focused on measuring Ageing-related low-grade inflammation;, inflammaging;, aging

Eligibility Criteria

40 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female patient, age 40 to 64 years. The inflammatory aging patient as defined in the protocol as TNF alpha or IL6 at the time of screening was higher than the 95% healthy percentile value declared by the test system manufacturer. Have at least 2 of the 3 following diseases: Diabetes type II Dyslipidemia Obesity [The diagnosis and determination of accompanying diseases (Diabetes, Dyslipidemia, Obesity) will be carried out according to the general guidance of the MOH Vietnam]. Patients are using stable drugs for co-infection (diabetes mellitus, dyslipidemia, obesity) stably in the past 3 months. Agree to participate in research and agree to comply with the research examination and evaluation process. Exclusion Criteria: Patients with a blood-clotting disorder or hemophilia Patients with severe heart failure Acute respiratory pathology at the time of screening Patients with cancer or other acute illness need treatment. Patients with a history of allergy to anesthetics, anesthesia, and antibiotics Patients are planning to participate in another clinical trial while participating in the study There are other conditions or circumstances in which it is difficult for researchers to ensure adherence to treatment in the judgment of researchers.

Sites / Locations

  • DNA International HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MSC transplantation

Arm Description

Transplant 100 million MSCs

Outcomes

Primary Outcome Measures

The safety and toleration of stem cell infusion
Assess the safety and tolerance of autologous adipose-derived mesenchymal stem cell transplantation in patients with inflammatory aging. During the entire duration of the study, the likelihood of adverse event occurrence and adverse event effects related or unrelated to stem cell infusion will be reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
The safety and toleration of stem cell infusion
Assess the safety and tolerance of autologous adipose-derived mesenchymal stem cell transplantation in patients with inflammatory aging. During the entire duration of the study, the likelihood of adverse event occurrence and adverse event effects related or unrelated to stem cell infusion will be reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
The safety and toleration of stem cell infusion
Assess the safety and tolerance of autologous adipose-derived mesenchymal stem cell transplantation in patients with inflammatory aging. During the entire duration of the study, the likelihood of adverse event occurrence and adverse event effects related or unrelated to stem cell infusion will be reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Secondary Outcome Measures

The change of proinflammatory cytokines after stem cell transplantation in patients
The measurement of proinflammatory cytokines concentration in patients peripheral blood such as IL-1α (pg/ml), IL-1β (pg/ml), TNF-α (pg/ml), TNF-β (pg/ml), IL-6 (pg/ml), IL-11 (pg/ml), IL-18 (pg/ml), IFN-γ (pg/ml) at day 0, 90, and 180 after stem cell infusion. During the study period, the variation of cytokine levels in individual patients revealed the results.
The change of anti-inflammatory cytokines after stem cell transplantation in patients
At day 0, 90, and 180 after stem cell infusion, the concentration of anti-inflammatory cytokines such as IL - 4 (pg/ml), IL-10 (pg/ml), EGF (pg/ml), and MCP-1 (pg/ml) in the peripheral blood of patients is measured. During the study period, the variation of cytokine levels in individual patients revealed the results.
The influence of stem cell transplantation on thechange of the ratio of pro-inflammatory to anti-inflammatory cytokines
The ratio of pro-inflammatory cytokines to anti-inflammatory cytokines will be used to assess the inflammation balance. The ratios from baseline were compared to three and six months after stem cell infusion such as IL-4/IL-10, IL-1/IL-10, IL-6/IL-10, and IL-1/EGF will be reported.

Full Information

First Posted
October 13, 2020
Last Updated
October 2, 2023
Sponsor
DNA International Hospital
Collaborators
University of Science Ho Chi Minh City
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1. Study Identification

Unique Protocol Identification Number
NCT05827757
Brief Title
Evaluating the Safety and Efficacy of Autologous Adipose Tissue-derived Mesenchymal Stem Cell Transplantation on Proinflammatory Cytokines and Anti-inflammatory Cytokines on Ageing-related Low-grade Inflammation Patients.
Official Title
Single-group, Open-label, Phase I / II Clinical Trial: Evaluating the Safety and Efficacy of Autologous Adipose Tissue-derived Mesenchymal Stem Cell Transplantation on Proinflammatory Cytokines and Cytokines Balance in Inflammaging (Ageing-related Low-grade Inflammation) Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2020 (Actual)
Primary Completion Date
April 13, 2025 (Anticipated)
Study Completion Date
April 13, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DNA International Hospital
Collaborators
University of Science Ho Chi Minh City

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Single-group, open-label, phase I / II clinical trial: Evaluation of the safety of autologous adipose tissue-derived mesenchymal stem cell transplantation in inflammaging (Ageing-related low-grade inflammation) patients.
Detailed Description
The proposed study is a single-group, open-label, phase I / II clinical trial in which the patients will be treated with two doses (100 million i.v) of autologous adipose tissue-derived mesenchymal stem cell transplantation. This study aims to evaluate the safety and efficiency of autologous adipose tissue-derived mesenchymal stem cell transplantation in inflammaging (Ageing-related low-grade inflammation) patients. The inflammaging-patients are who have cytokine increasing (IL6 and TNF alfa)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging Problems, Aging, Chronic Inflammation
Keywords
Ageing-related low-grade inflammation;, inflammaging;, aging

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Evaluating the Safety and Efficacy of Autologous Adipose Tissue-derived Mesenchymal Stem Cell Transplantation on Proinflammatory Cytokines and Anti-inflammatory Cytokines on Ageing-related Low-grade Inflammation Patients.
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MSC transplantation
Arm Type
Experimental
Arm Description
Transplant 100 million MSCs
Intervention Type
Biological
Intervention Name(s)
autologous adipose-derived mesenchymal stem cell transplantation
Intervention Description
Transplant 100 million autologous adipose-derived mesenchymal stem cells at Day 0 and Day 90
Primary Outcome Measure Information:
Title
The safety and toleration of stem cell infusion
Description
Assess the safety and tolerance of autologous adipose-derived mesenchymal stem cell transplantation in patients with inflammatory aging. During the entire duration of the study, the likelihood of adverse event occurrence and adverse event effects related or unrelated to stem cell infusion will be reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time Frame
Study recruirement day 0
Title
The safety and toleration of stem cell infusion
Description
Assess the safety and tolerance of autologous adipose-derived mesenchymal stem cell transplantation in patients with inflammatory aging. During the entire duration of the study, the likelihood of adverse event occurrence and adverse event effects related or unrelated to stem cell infusion will be reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time Frame
Day 90
Title
The safety and toleration of stem cell infusion
Description
Assess the safety and tolerance of autologous adipose-derived mesenchymal stem cell transplantation in patients with inflammatory aging. During the entire duration of the study, the likelihood of adverse event occurrence and adverse event effects related or unrelated to stem cell infusion will be reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time Frame
Study endpoint at day 180
Secondary Outcome Measure Information:
Title
The change of proinflammatory cytokines after stem cell transplantation in patients
Description
The measurement of proinflammatory cytokines concentration in patients peripheral blood such as IL-1α (pg/ml), IL-1β (pg/ml), TNF-α (pg/ml), TNF-β (pg/ml), IL-6 (pg/ml), IL-11 (pg/ml), IL-18 (pg/ml), IFN-γ (pg/ml) at day 0, 90, and 180 after stem cell infusion. During the study period, the variation of cytokine levels in individual patients revealed the results.
Time Frame
Day 0, Day 90 and Day 180
Title
The change of anti-inflammatory cytokines after stem cell transplantation in patients
Description
At day 0, 90, and 180 after stem cell infusion, the concentration of anti-inflammatory cytokines such as IL - 4 (pg/ml), IL-10 (pg/ml), EGF (pg/ml), and MCP-1 (pg/ml) in the peripheral blood of patients is measured. During the study period, the variation of cytokine levels in individual patients revealed the results.
Time Frame
Day 0, Day 90 and Day 180
Title
The influence of stem cell transplantation on thechange of the ratio of pro-inflammatory to anti-inflammatory cytokines
Description
The ratio of pro-inflammatory cytokines to anti-inflammatory cytokines will be used to assess the inflammation balance. The ratios from baseline were compared to three and six months after stem cell infusion such as IL-4/IL-10, IL-1/IL-10, IL-6/IL-10, and IL-1/EGF will be reported.
Time Frame
Day 0, Day 90 and Day 180

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patient, age 40 to 64 years. The inflammatory aging patient as defined in the protocol as TNF alpha or IL6 at the time of screening was higher than the 95% healthy percentile value declared by the test system manufacturer. Have at least 2 of the 3 following diseases: Diabetes type II Dyslipidemia Obesity [The diagnosis and determination of accompanying diseases (Diabetes, Dyslipidemia, Obesity) will be carried out according to the general guidance of the MOH Vietnam]. Patients are using stable drugs for co-infection (diabetes mellitus, dyslipidemia, obesity) stably in the past 3 months. Agree to participate in research and agree to comply with the research examination and evaluation process. Exclusion Criteria: Patients with a blood-clotting disorder or hemophilia Patients with severe heart failure Acute respiratory pathology at the time of screening Patients with cancer or other acute illness need treatment. Patients with a history of allergy to anesthetics, anesthesia, and antibiotics Patients are planning to participate in another clinical trial while participating in the study There are other conditions or circumstances in which it is difficult for researchers to ensure adherence to treatment in the judgment of researchers.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huynh Nguyen, MD
Phone
+84 982902928
Email
bshuynhnguyen@benhvienquoctedna.vn
First Name & Middle Initial & Last Name or Official Title & Degree
Nhung H Truong, Ph.D
Phone
+84 907974904
Email
thnhung@hcmus.edu.vn
Facility Information:
Facility Name
DNA International Hospital
City
Ho Chi Minh City
State/Province
District 05
ZIP/Postal Code
70000
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao T Phan, MD
Phone
+84 917446633
Email
drhao@benhvienquoctedna.vn
First Name & Middle Initial & Last Name & Degree
H

12. IPD Sharing Statement

Learn more about this trial

Evaluating the Safety and Efficacy of Autologous Adipose Tissue-derived Mesenchymal Stem Cell Transplantation on Proinflammatory Cytokines and Anti-inflammatory Cytokines on Ageing-related Low-grade Inflammation Patients.

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