Using stem cells from fat to treat inflammation in older adults

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.

This study is testing if using stem cells taken from fat can help older adults with inflammation feel better and improve their health.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 40 Years to 64 Years
• Sex: All
• Sponsor: DNA International Hospital (other)
• Locations: 1 site (Ho Chi Minh City, District 05)
• Trial ID: NCT05827757 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of autologous adipose tissue-derived mesenchymal stem cell transplantation in patients experiencing age-related low-grade inflammation. Participants will receive two doses of stem cells derived from their own fat tissue, aiming to reduce pro-inflammatory cytokines like IL6 and TNF alpha. The study is designed as a single-group, open-label trial, focusing on patients aged 40 to 64 who have elevated inflammatory markers and related health conditions. The goal is to assess both the safety of the treatment and its potential to improve inflammatory responses in this population.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 40 to 64 with age-related low-grade inflammation and at least two of the following conditions: type II diabetes, dyslipidemia, or obesity.

Not a fit: Patients with severe heart failure, blood-clotting disorders, acute respiratory issues, or cancer are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce inflammation and improve health outcomes for older adults suffering from chronic inflammatory conditions.

How similar studies have performed: While the approach of using autologous stem cells is gaining interest, this specific application in treating inflammaging is relatively novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Ho Chi Minh City, District 05

• DNA International Hospital — Ho Chi Minh City, District 05, Vietnam (RECRUITING)

Study contacts

• Study coordinator: Huynh Nguyen, MD

Conditions: Aging Problems, Aging, Chronic Inflammation, Ageing-related low-grade inflammation, inflammaging, aging