Pilot Study of Human Adipose Tissue Derived Exosomes Promoting Wound Healing

NCT05475418 | Completed

• 1 other identifier: Drkailiu
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Wounds and Injuries

Outcome Measures

Primary Outcomes (1)

• Percentage of wound healing in each group at 4 weeks

  Percentage of wound healing

  4 weeks

Interventions

Adipose tissue derived exosomes PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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%

You may not qualify if:

• \. 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.
• \. 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.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, China

Location

Related Publications (1)

• 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.

  PMID: 38169960 DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Kai Liu, MD,PhD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2022
• First Posted: July 26, 2022
• Study Start: August 5, 2022
• Primary Completion: December 30, 2022
• Study Completion: October 15, 2023
• Last Updated: October 19, 2023

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)