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.

DNA International Hospital

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Aging; Chronic Inflammation; Aging Problems

Treatments: Biological: autologous adipose-derived mesenchymal stem cell transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT05827757

1690/QĐ-BYT

Details and patient eligibility

About

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.

Full 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)

Enrollment: 72 estimated patients

Sex: All

Ages: 40 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

72 participants in 1 patient group

MSC transplantation

Experimental group

Description:

Transplant 100 million MSCs

Treatment:

Biological: autologous adipose-derived mesenchymal stem cell transplantation