Autologous Adipose Stem Cell Assisted Skin Graft

Not Applicable

Not yet recruiting

• Conditions: Skin Graft
• Interventions: Procedure: autologous adipose stem cell injection; Procedure: saline injection

• Registration Number: NCT04532593
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-21
• Study First Submitted QC: 2020-08-25
• Last Update Submitted: 2020-08-25
• Study First Posted: 2020-08-31
• Last Update Posted: 2020-08-31
• Study Start: 2020-10-01
• Primary Completion: 2022-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stem cell group	autologous adipose stem cell injection	-
Control	saline injection	-

Primary Outcome Measures

Name	Time	Method
Skin elasticity	6 months	Skin elasticity analyzed by Cutometer. The R2 value is used to evaluated the skin elasticity.

Secondary Outcome Measures

Name	Time	Method
Skin elasticity	12 months	Skin elasticity analyzed by Cutometer. The R2 value is used to evaluated the skin elasticity.
POSAS questionnaire of investigator	12 months	POSAS questionnaire of investigator. Six questions of vascularity, pigmentation, texture, thickness, pliability, surface area. Each question ranks 0, 1, 2. Total score is 0 to 12.
POSAS questionnaire of patient	12 months	POSAS questionnaire of patient. Five questions of pain, itch, thickness, color, stiffness, irregularity. Each question ranks 0, 1, 2. Total score is 0 to 10.
Skin color	12 months	Skin color analyzed by CK Colorimeter CL400. The iTA value is used to evaluate the color of skin graft.