Using fat-derived vesicles to improve wound healing

A Randomized, Controlled, Multicenter Study of Human Adipose Tissue Derived Extracellular Vesicles Promoting Wound Healing

This study is testing whether tiny particles from fat can help people with stubborn skin ulcers heal faster than a placebo.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 69 Years
• Sex: All
• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University (other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06253975 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of extracellular vesicles derived from human adipose tissue in promoting the healing of chronic wounds. Participants are randomly assigned to receive either the adipose tissue-derived extracellular vesicles (AT-EVs) or a placebo, allowing for a controlled comparison of outcomes. The study focuses on patients with full-layer skin ulcers that have persisted for at least four weeks, assessing the impact of AT-EVs on wound healing rates. The trial aims to provide insights into a novel therapeutic approach for difficult-to-heal wounds.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 69 with chronic full-layer skin ulcers lasting from four weeks to one year.

Not a fit: Patients with wounds that are not classified as chronic or those who have scheduled vascular surgeries within the study timeframe may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly enhance healing rates for patients with chronic wounds.

How similar studies have performed: While the use of adipose-derived products in wound healing is an emerging field, this specific approach using AT-EVs is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* 1. Age 18 to 69 years old, regardless of gender 2. Full-layer skin ulcers on various parts of the body, lasting from 4 weeks to 1 year

  1. If the wound is post-amputation, the time from surgery must be \>30 days;
  2. If there is \>1 wound surface, the maximum wound surface is selected as the research target; 3. At the beginning of the induction period, the wound size after debridement was ≥1 and ≤20 cm2; 4.Texas classification 1A, 1B, 1C, 1D, 2A, 2B, 2C or 2D; 5. Ankle-brachial index ≥0.7, including percutaneous oxygen pressure (TcPO2) ≥30 mm Hg and cutaneous perfusion pressure ≥30 mm Hg; 6. Revascularization procedures or vascular surgery that are not scheduled in the past or the next 30 days; 7. The subject and family members are willing and able to comply with all prescribed care and medical requirements; 8. The subject has a reasonable expectation of completing the study; 9. The subject completed the 2-week induction period and the wound was reduced by 30%

Exclusion Criteria:

* 1. The subject has signs of gangrene in any part of the trunk and limbs; 2. A written diagnosis of osteomyelitis in any part of the affected limb; 3. Bone tissue at the wound site of the subject is exposed; 4. Poor blood glucose control in subjects: HbA1c\>12% (108 mmol/mol); 5. Subjects are receiving renal dialysis treatment or creatinine \>2.5mg/dl (221mmol/L); 6. The subject has obvious immune deficiency; 7. The subject has suspected tumor or is receiving tumor treatment; 8. Subject has used steroids or immunosuppressants in the past 3 months or is expected to use them during the study; 9. Subjects received growth factor therapy, autologous platelet-rich plasma gel, double-layer cell therapy, dermal substitute, extracellular matrix, etc., during the screening period; 10. The subject has participated in another research device, drug, or biological trial within the past 30 days; 11. The wound shows serious clinical symptoms of infection, requiring hospitalization or immediate surgical treatment; 12. The subject has developed deep vein thrombosis within the past 30 days; 13. The subject is pregnant or breastfeeding; 14. The subject has serious mental illness and psychological disorder; 15. The subject was judged unfit for the test by the attending physician.

Where this trial is running

Shanghai, Shanghai

• Shanghai 9th People's Hospital — Shanghai, Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Kai Liu, M.D., Ph.D.

Conditions: Wound Heal