Pilot Study of Human Adipose Tissue Derived Exosomes Promoting Wound Healing

NCT ID: NCT05475418

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-05
• Study Completion Date: 2023-10-15

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 1. Age from 18 to 60, regardless of gender; 2. Full-layer skin wounds on various parts of the body, lasting 4-8 weeks A. For post-amputation wounds, the time between operation and amputation must be more than 30 days; B. If there are wounds >1, select the largest wound as the research target; 3. At the beginning of the induction period, the wound size after debridement was ≥1 and ≤20 cm2; 4. Texas grade 1A, 1B, 1C, 1D, 2A, 2B, 2C or 2D; 5. Ankle-brachial index ≥0.7, including percutaneous oxygen pressure (TcPO2) ≥30 mm hg and skin perfusion pressure ≥30 mm hg; 6. No revascularization procedure or vascular surgery planned within the past or next 30 days; 7. The subject and their family members are willing and able to comply with all prescribed requirements for care and consultation; 8. Subjects have reasonable expectations of completing the study; 9. Subjects completed 2 weeks of initiation and wound reduction was 30%

Exclusion Criteria

• 1. Signs of gangrene in any part of the torso and limbs of the subject; 2. Written diagnosis of osteomyelitis in any part of the affected limb; 3. Bone tissue at the wound site was exposed; 4. Poor blood glucose control: HbA1c>12% (108 mmol/mol); 5. Subject is receiving kidney dialysis 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. Long-term use of steroids or immunosuppressants within the past 3 months or expected use during the study period; 9. During the screening period, subjects have received growth factor therapy, autologous platelet-rich plasma gel, bilayer cell therapy, dermal substitutes, extracellular matrix, etc.

10. Subject participated in another research device, drug or biological trial within the past 30 days; 11. The wound showed severe symptoms of clinical 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 abnormality; 15. The subject was determined by the attending physician to be unfit for this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kai Liu, MD,PhD

Role: STUDY_CHAIR

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Locations

Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, China

Countries

China

References

Liu W, Liu T, Zhao Q, Ma J, Jiang J, Shi H. Adipose Tissue-Derived Extracellular Vesicles: A Promising Biomarker and Therapeutic Strategy for Metabolic Disorders. Stem Cells Int. 2023 Dec 26;2023:9517826. doi: 10.1155/2023/9517826. eCollection 2023.

Reference Type: DERIVED

PMID: 38169960 (View on PubMed)

Other Identifiers

Drkailiu

Identifier Type: -

Identifier Source: org_study_id