Skin GraftNCT04532593
Autologous Adipose Stem Cell Assisted Skin Graft
A study testing autologous adipose stem cell injection and saline injection in people with Skin Graft, run by Shanghai Jiao Tong University School of Medicine.
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. Read more about this study
- Who is it for?
- Ages 6 to 70 years
- Conditions the study is for
- Skin Graft
- What is being tested?
- autologous adipose stem cell injection and saline injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: 6-70 years old;
- Gender: male and female;
- Scar, surface tumor or soft tissue defect evaluated to be suitable for skin grafting;
- With two skin grafting areas and the edges more than 4cm apart;
- Sign informed consent, participate in the study and be able to cooperate with the follow-up.
Who cannot join
- Those who are not suitable for skin grafting;
- 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;
- With severe medical diseases (such as diabetes, hepatitis, coronary heart disease, arteriosclerosis, glomerulonephritis, autoimmune diseases, etc.) were complicated;
- Those who are receiving anticoagulant therapy and cannot suspend treatment;
- 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,
- Those who can't tolerate the operation risk according to the surgeon's evaluation;
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- Pregnant and lactating women;
- Those who have mental illness, have no insight, can not express and cooperate with each other;
- Participant in other clinical trials within 30 days before the screen visit of this trial;
- Those who have not signed the informed consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Placebo Controlled, Single-blinded Clinical Trial to Evaluate the Efficiency of Autologous Adipose Stem Cell in Promoting Skin Graft
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.
- Conditions
- Skin Graft
- Being tested
- autologous adipose stem cell injection, saline injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous adipose stem cell injectionProcedure or surgery
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 injectionProcedure or surgery
saline will be injected underneath skin graft (0.05 ml/cm2).
| Study group | Role | What they receive |
|---|---|---|
| Stem cell group | Experimental | Not described Receives: Procedure: autologous adipose stem cell injection |
| Control | Placebo comparator | Not described Receives: Procedure: saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin elasticity
Skin elasticity analyzed by Cutometer. The R2 value is used to evaluated the skin elasticity.
Measured: 6 months
Secondary outcomes (11)
Skin elasticity
Skin elasticity analyzed by Cutometer. The R2 value is used to evaluated the skin elasticity.
Measured: 3 months
Skin elasticity
Skin elasticity analyzed by Cutometer. The R2 value is used to evaluated the skin elasticity.
Measured: 12 months
Skin color
Skin color analyzed by CK Colorimeter CL400. The iTA value is used to evaluate the color of skin graft.
Measured: 3 months
Skin color
Skin color analyzed by CK Colorimeter CL400. The iTA value is used to evaluate the color of skin graft.
Measured: 6 months
Skin color
Skin color analyzed by CK Colorimeter CL400. The iTA value is used to evaluate the color of skin graft.
Measured: 12 months
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.
Measured: 3 months
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.
Measured: 6 months
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.
Measured: 12 months
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.
Measured: 3 months
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.
Measured: 6 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start1 Oct 2020 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin GraftStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Huaxi Hospital, Ruijin Hospital, Shanghai Zhongshan Hospital, The First Affiliated Hospital of Zhengzhou University
- Responsible party
- Principal investigator, Qing-FengLi Li,MD, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532593
- Sponsor's protocol ID
- SH9H-2020-T185-1
- Status last verified
- Aug 2020
- First submitted
- 21 Aug 2020
- Last updated
- 31 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled, Single-blinded Clinical Trial to Evaluate the Efficiency of Autologous Adipose Stem Cell in Promoting Skin Graft
- ClinicalTrials.gov ID
- NCT04532593
- Acronym / sponsor ID
- SH9H-2020-T185-1
- Conditions
- Skin Graft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Huaxi Hospital, Ruijin Hospital, Shanghai Zhongshan Hospital, The First Affiliated Hospital of Zhengzhou University
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 31 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stem cell group | Experimental | Procedure: autologous adipose stem cell injection |
| Control | Placebo comparator | Procedure: saline injection |
Who may qualify
- Ages
- 6 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 6-70 years old;
- Gender: male and female;
- Scar, surface tumor or soft tissue defect evaluated to be suitable for skin grafting;
- With two skin grafting areas and the edges more than 4cm apart;
- Sign informed consent, participate in the study and be able to cooperate with the follow-up.
Key exclusion criteria (10 listed)
- Those who are not suitable for skin grafting;
- 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;
- With severe medical diseases (such as diabetes, hepatitis, coronary heart disease, arteriosclerosis, glomerulonephritis, autoimmune diseases, etc.) were complicated;
- Those who are receiving anticoagulant therapy and cannot suspend treatment;
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous adipose stem cell injectionAbdominal 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). | Procedure or surgery | Stem cell group |
| saline injectionsaline will be injected underneath skin graft (0.05 ml/cm2). | Procedure or surgery | Control |
Primary outcome
Skin elasticity
Time frame: 6 months
Skin elasticity analyzed by Cutometer. The R2 value is used to evaluated the skin elasticity.
11 secondary outcomes
Skin elasticity
Time frame: 3 months
Skin elasticity
Time frame: 12 months
Skin color
Time frame: 3 months
Skin color
Time frame: 6 months
Skin color
Time frame: 12 months
POSAS questionnaire of patient
Time frame: 3 months
POSAS questionnaire of patient
Time frame: 6 months
POSAS questionnaire of patient
Time frame: 12 months
POSAS questionnaire of investigator
Time frame: 3 months
POSAS questionnaire of investigator
Time frame: 6 months
POSAS questionnaire of investigator
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing autologous adipose stem cell injection and saline injection in people with Skin Graft, run by Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qing-Feng Li (+862123271699, shuangbaizhou@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin elasticity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2020.