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

Wound Heal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06253975
• Other study ID #: Drkailiu-RCT
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: Kai Liu, M.D., Ph.D.
• Phone: +86 13501909852
• Email: drkailiu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

By randomly assigning study subjects into groups, interventions with adipose tissue-derived extracellular vesicles (AT-EVs) and placebos are conducted to evaluate whether AT-EVs can promote effective healing of recalcitrant wounds.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Wound Heal
• Wounds and Injuries

Intervention

Biological:
• adipose tissue derived extracellular vesicles (AT-EVs)
Extracellular vesicles from patient's adipose tissue together with HA

Drug:
• Hyaluronic acid
Use HA only as a placebo

Locations

Country	Name	City	State
China	Shanghai 9th People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of wound healing in each group at 10 weeks	The percentage of wound healing in each group at 10 weeks was calculated as: (initial wound area - wound area at 10 weeks of treatment)/initial wound area ×100%.	10 weeks