Autologous Adipose Stem Cell Assisted Skin Graft

Skin Graft Clinical Trial

Official title:

A Randomized, Placebo Controlled, Single-blinded Clinical Trial to Evaluate the Efficiency of Autologous Adipose Stem Cell in Promoting Skin Graft

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04532593
• Other study ID #: SH9H-2020-T185-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: September 30, 2024

Study information

• Verified date: August 2020
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Qing-Feng Li
• Phone: +862123271699
• Email: shuangbaizhou[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Skin Graft

Intervention

Procedure:
• autologous adipose stem cell injection
Abdominal or buttock fat will be aspirated under local anesthesia or general anesthesia by conventional methods (0.5 ml fat was aspirated per 1 cm2 of skin graft area). The matrix component rich in adipose stem cells will be obtained by chopping, washing and centrifugation. The intervention treatment will be performed after the skin graft sutured. The stem cell components will be injected underneath the skin graft (0.05 ml/cm2).
• saline injection
saline will be injected underneath skin graft (0.05 ml/cm2).

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine	Huaxi Hospital, Ruijin Hospital, Shanghai Zhongshan Hospital, The First Affiliated Hospital of Zhengzhou University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin elasticity	Skin elasticity analyzed by Cutometer. The R2 value is used to evaluated the skin elasticity.	6 months
Secondary	Skin elasticity	Skin elasticity analyzed by Cutometer. The R2 value is used to evaluated the skin elasticity.	3 months
Secondary	Skin elasticity	Skin elasticity analyzed by Cutometer. The R2 value is used to evaluated the skin elasticity.	12 months
Secondary	Skin color	Skin color analyzed by CK Colorimeter CL400. The iTA value is used to evaluate the color of skin graft.	3 months
Secondary	Skin color	Skin color analyzed by CK Colorimeter CL400. The iTA value is used to evaluate the color of skin graft.	6 months
Secondary	Skin color	Skin color analyzed by CK Colorimeter CL400. The iTA value is used to evaluate the color of skin graft.	12 months
Secondary	POSAS questionnaire of patient	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.	3 months
Secondary	POSAS questionnaire of patient	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.	6 months
Secondary	POSAS questionnaire of patient	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.	12 months
Secondary	POSAS questionnaire of investigator	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.	3 months
Secondary	POSAS questionnaire of investigator	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.	6 months
Secondary	POSAS questionnaire of investigator	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.	12 months