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.
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2020
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 28, 2020
CompletedFirst Submitted
Initial submission to the registry
October 13, 2020
CompletedFirst Posted
Study publicly available on registry
April 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 13, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 13, 2025
CompletedOctober 4, 2023
October 1, 2023
5 years
October 13, 2020
October 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
The change of proinflammatory cytokines after stem cell transplantation in patients
Day 0, Day 90 and Day 180
The change of anti-inflammatory cytokines after stem cell transplantation in patients
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
Day 0, Day 90 and Day 180
Study Arms (1)
MSC transplantation
EXPERIMENTALTransplant 100 million MSCs
Interventions
Transplant 100 million autologous adipose-derived mesenchymal stem cells at Day 0 and Day 90
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DNA International Hospitallead
- University of Science Ho Chi Minh Citycollaborator
Study Sites (1)
DNA International Hospital
Ho Chi Minh City, District 05, 70000, Vietnam
Related Publications (1)
Nguyen NT, Phan HT, Le PM, Nguyen LT, Do TT, Phan TT, Van Le T, Dang TM, Phan CL, Dang TT, Truong NH. Safety and efficacy of autologous adipose tissue-derived stem cell transplantation in aging-related low-grade inflammation patients: a single-group, open-label, phase I clinical trial. Trials. 2024 May 8;25(1):309. doi: 10.1186/s13063-024-08128-3.
PMID: 38715140DERIVED
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2020
First Posted
April 25, 2023
Study Start
April 28, 2020
Primary Completion
April 13, 2025
Study Completion
April 13, 2025
Last Updated
October 4, 2023
Record last verified: 2023-10