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.

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Aging; Chronic Inflammation; Aging Problems
• Intervention / Treatment: Biological: autologous adipose-derived mesenchymal stem cell transplantation

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)

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Huynh Nguyen, MD; Phone Number: +84 982902928; Email: bshuynhnguyen@benhvienquoctedna.vn
• Study Contact Backup: Name: Nhung H Truong, Ph.D; Phone Number: +84 907974904; Email: thnhung@hcmus.edu.vn

Study Locations

• Vietnam
  • District 05
    • Ho Chi Minh City, District 05, Vietnam, 70000
      • Recruiting
      • DNA International Hospital
      • Contact: H
      • Contact: Hao T Phan, MD; Phone Number: +84 917446633; Email: drhao@benhvienquoctedna.vn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female patient, age 40 to 64 years.
2. 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.

3. 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].
4. Patients are using stable drugs for co-infection (diabetes mellitus, dyslipidemia, obesity) stably in the past 3 months.
5. Agree to participate in research and agree to comply with the research examination and evaluation process.

Exclusion Criteria:

1. Patients with a blood-clotting disorder or hemophilia
2. Patients with severe heart failure
3. Acute respiratory pathology at the time of screening
4. Patients with cancer or other acute illness need treatment.
5. Patients with a history of allergy to anesthetics, anesthesia, and antibiotics
6. Patients are planning to participate in another clinical trial while participating in the study
7. There are other conditions or circumstances in which it is difficult for researchers to ensure adherence to treatment in the judgment of researchers.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MSC transplantation; Transplant 100 million MSCs	Biological: autologous adipose-derived mesenchymal stem cell transplantation; Transplant 100 million autologous adipose-derived mesenchymal stem cells at Day 0 and Day 90

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Study recruirement day 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.	Day 90
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.	Study endpoint at day 180

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0, Day 90 and Day 180
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.	Day 0, Day 90 and Day 180
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.	Day 0, Day 90 and Day 180

Collaborators and Investigators

• Sponsor: DNA International Hospital
• Collaborators: University of Science Ho Chi Minh City

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2020
• Primary Completion (Estimated): April 13, 2025
• Study Completion (Estimated): April 13, 2025

Study Registration Dates

• First Submitted: October 13, 2020
• First Submitted That Met QC Criteria: April 23, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: aging; Ageing-related low-grade inflammation;; inflammaging
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 1690/QĐ-BYT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No