Clinical trial NCT05827757: 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
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Aging Problems
Aging
Chronic Inflammation
Keywords: Ageing-related low-grade inflammation;
inflammaging;
aging
Lead sponsor: DNA International Hospital
Sponsor class: OTHER
Collaborators: name: University of Science Ho Chi Minh City
First posted: 2023-04-25
Enrollment: 72
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

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)

Eligibility criteria: 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.

Primary outcomes:
measure: The safety and toleration of stem cell infusion
timeFrame: Study recruirement day 0
measure: The safety and toleration of stem cell infusion
timeFrame: Day 90
measure: The safety and toleration of stem cell infusion
timeFrame: Study endpoint at day 180
Secondary outcomes:
measure: The change of proinflammatory cytokines after stem cell transplantation in patients
timeFrame: Day 0, Day 90 and Day 180
measure: The change of anti-inflammatory cytokines after stem cell transplantation in patients
timeFrame: Day 0, Day 90 and Day 180
measure: The influence of stem cell transplantation on thechange of the ratio of pro-inflammatory to anti-inflammatory cytokines
timeFrame: Day 0, Day 90 and Day 180
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: DNA International Hospital
state: District 05
Study officials:
References: