NCT05475418

Pilot Study of Human Adipose Tissue Derived Exosomes Promoting Wound Healing

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study is a one-arm pilot study. All patients were recruited on an outpatient basis. After screening visits and informed consent was obtained, debridement and photography were performed on the patient's wound surface, and the wound area was measured. Patients in the intervention group were then provided with adipose tissue exosome dressings.200-300ml of the subject adipose tissue before centrifugation was collected, and the extracellular vesicles were retained after tissue homogenate and filter screening. The extracellular vesicles were mixed with sterile hydrogel and applied directly to the wound surface, and the wound was covered with an inert protective dressing.

Detailed description

After giving written informed consent, participants will be followed up once a week during the 2-week lead-in period to confirm that they meet the inclusion criteria.Patients who meet inclusion and exclusion criteria at the end of the induction period will receive treatment twice a week for 4 weeks or until recovery, whichever occurs first.When the observer confirmed that the wound had healed, the patient was followed up for two healing visits within the next 2 weeks.If the evaluator confirms target wound healing at the 4-week confirmatory follow-up, subjects will enter the study follow-up phase, which will be completed at 4 and 6 weeks after the end of the initiation phase.If the target wound did not heal after 6 weeks of treatment, participants completed follow-up at 4 and 6 weeks after the initiation period.

Conditions

• Wounds and Injuries

Interventions

Type	Name	Description
PROCEDURE	Adipose tissue derived exosomes	200-300ml of the subject adipose tissue before centrifugation was collected, and the extracellular vesicles were retained after tissue homogenate and filter screening. The extracellular vesicles were mixed with sterile hydrogel and applied directly to the wound surface, and the wound was covered with an inert protective dressing.

Timeline

• Start date: 2022-08-05
• Primary completion: 2022-12-30
• Completion: 2023-10-15
• First posted: 2022-07-26
• Last updated: 2023-10-19

Locations

1 site across 1 country: China