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.
NCT ID: NCT05827757
Last Updated: 2023-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
72 participants
INTERVENTIONAL
2020-04-28
2025-04-13
Brief Summary
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Detailed Description
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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)
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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MSC transplantation
Transplant 100 million MSCs
autologous adipose-derived mesenchymal stem cell transplantation
Transplant 100 million autologous adipose-derived mesenchymal stem cells at Day 0 and Day 90
Interventions
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autologous adipose-derived mesenchymal stem cell transplantation
Transplant 100 million autologous adipose-derived mesenchymal stem cells at Day 0 and Day 90
Eligibility Criteria
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Inclusion Criteria
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
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.
40 Years
64 Years
ALL
No
Sponsors
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University of Science Ho Chi Minh City
OTHER
DNA International Hospital
OTHER
Responsible Party
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Locations
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DNA International Hospital
Ho Chi Minh City, District 05, Vietnam
Countries
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Central Contacts
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Facility Contacts
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H
Role: backup
References
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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.
Other Identifiers
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1690/QĐ-BYT
Identifier Type: -
Identifier Source: org_study_id
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