Clinical trial NCT04532593: Autologous Adipose Stem Cell Assisted Skin Graft
Official title: A Randomized, Placebo Controlled, Single-blinded Clinical Trial to Evaluate the Efficiency of Autologous Adipose Stem Cell in Promoting Skin Graft
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Skin Graft
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Huaxi Hospital
name: Ruijin Hospital
name: Shanghai Zhongshan Hospital
name: The First Affiliated Hospital of Zhengzhou University
First posted: 2020-08-31
Enrollment: 75
Sex: ALL
Minimum age (years): 6
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Skin graft is a commonly used method in wound repair. The long-term outcome of skin graft is unsatisfied because of the complications of contraction, pigmentation and stiffness. In our preclinical researches, we found that adipose stem cell can improve the texture of grafted skin and reduce contraction. In this trial, we will evaluate the efficiency and safety of autologous adipose stem cells in improving skin graft outcomes.


Eligibility criteria: Inclusion Criteria:

1. Age: 6-70 years old;
2. Gender: male and female;
3. Scar, surface tumor or soft tissue defect evaluated to be suitable for skin grafting;
4. With two skin grafting areas and the edges more than 4cm apart;
5. Sign informed consent, participate in the study and be able to cooperate with the follow-up.

Exclusion Criteria:

1. Those who are not suitable for skin grafting;
2. There who are with local lesions in the operation area, such as infection, blood supply disturbance, delayed healing history, decreased soft tissue vitality, history of radiotherapy or going to receive radiotherapy, active ulcer, etc;
3. With severe medical diseases (such as diabetes, hepatitis, coronary heart disease, arteriosclerosis, glomerulonephritis, autoimmune diseases, etc.) were complicated;
4. Those who are receiving anticoagulant therapy and cannot suspend treatment;
5. Those who are with abnormal blood routine test, abnormal coagulation function, abnormal cardiac function, abnormal liver function or renal function evaluated by researchers according to the laboratory examination and other clinical signs and symptoms,
6. Those who can't tolerate the operation risk according to the surgeon's evaluation;
7. Pregnant and lactating women;
8. Those who have mental illness, have no insight, can not express and cooperate with each other;
9. Participant in other clinical trials within 30 days before the screen visit of this trial;
10. Those who have not signed the informed consent.

Primary outcomes:
measure: Skin elasticity
timeFrame: 6 months
Secondary outcomes:
measure: Skin elasticity
timeFrame: 3 months
measure: Skin elasticity
timeFrame: 12 months
measure: Skin color
timeFrame: 3 months
measure: Skin color
timeFrame: 6 months
measure: Skin color
timeFrame: 12 months
measure: POSAS questionnaire of patient
timeFrame: 3 months
measure: POSAS questionnaire of patient
timeFrame: 6 months
measure: POSAS questionnaire of patient
timeFrame: 12 months
measure: POSAS questionnaire of investigator
timeFrame: 3 months
measure: POSAS questionnaire of investigator
timeFrame: 6 months
measure: POSAS questionnaire of investigator
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References: