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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-28

Study Completion Date

2025-04-13

Brief Summary

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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

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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)

Conditions

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Aging Problems Aging Chronic Inflammation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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MSC transplantation

Transplant 100 million MSCs

Group Type EXPERIMENTAL

autologous adipose-derived mesenchymal stem cell transplantation

Intervention Type BIOLOGICAL

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Science Ho Chi Minh City

OTHER

Sponsor Role collaborator

DNA International Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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DNA International Hospital

Ho Chi Minh City, District 05, Vietnam

Site Status RECRUITING

Countries

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Vietnam

Central Contacts

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Huynh Nguyen, MD

Role: CONTACT

+84 982902928

Nhung H Truong, Ph.D

Role: CONTACT

+84 907974904

Facility Contacts

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Hao T Phan, MD

Role: primary

+84 917446633

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.

Reference Type DERIVED
PMID: 38715140 (View on PubMed)

Other Identifiers

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1690/QĐ-BYT

Identifier Type: -

Identifier Source: org_study_id

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