Back to resultsPilot Study of Human Adipose Tissue Derived Exosomes Promoting Wound Healing
Primary Purpose
Wounds and Injuries
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Adipose tissue derived exosomes
Sponsored by
About this trial
This is an interventional treatment trial for Wounds and Injuries
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.
Sites / Locations
- Shanghai Ninth People's Hospital
Outcomes
Primary Outcome Measures
Percentage of wound healing in each group at 4 weeks
Percentage of wound healing
Secondary Outcome Measures
Full Information
NCT ID
NCT05475418
First Posted
July 24, 2022
Last Updated
October 17, 2023
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1. Study Identification
Unique Protocol Identification Number
NCT05475418
Brief Title
Pilot Study of Human Adipose Tissue Derived Exosomes Promoting Wound Healing
Official Title
Pilot Study of Human Adipose Tissue Derived Exosomes Promoting Wound Healing
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 5, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
October 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds and Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Adipose tissue derived exosomes
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of wound healing in each group at 4 weeks
Description
Percentage of wound healing
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai Liu, MD,PhD
Organizational Affiliation
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai Ninth People's Hospital
City
Shanghai
State/Province
Shanghai
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pilot Study of Human Adipose Tissue Derived Exosomes Promoting Wound Healing
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