UnknownPhase 1/2

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.

Vietnam72 participantsStarted 2020-04-28

Plain-language 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.

Who can participate

Age range40 Years – 64 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

The safety and toleration of stem cell infusion

Timeframe: Study recruirement day 0

The safety and toleration of stem cell infusion

Timeframe: Day 90

The safety and toleration of stem cell infusion

Timeframe: Study endpoint at day 180

Trial details

NCT IDNCT05827757

SponsorDNA International Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-13

Contact for this trial

Huynh Nguyen, MD

+84 982902928 bshuynhnguyen@benhvienquoctedna.vn

View on ClinicalTrials.gov More Aging Problems trials

Who can participate

Age range40 Years – 64 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. 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.

Exclusion criteria

✕. 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.