Safety and Exploratory Efficacy Study of Collagen Membrane With Mesenchymal Stem Cells in the Treatment of Skin Defects

Study Overview
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Brief Summary
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The purpose of the present study is to evaluate the safety and exploratory efficacy of the medical collagen membrane with umbilical cord derived mesenchymal stem cells in the treatment of patients with skin defects.

Conditions
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Wounds, Diabetic Foot Ulcers, Burns

Intervention / Treatment
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* Device: Medical Collagen Membrane with MSC
* Device: Medical Collagen Membrane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 70, borh gender. Patient able and willing to sign informed consent and comply with study procedures. Women of childbearing potential must use birth control pills, barriers or abstinence and have a negative pregnancy test. Deep partial or full thickness skin defect of at least 9 cm2 requiring surgical wound coverage due to: burn injury, diabetic foot ulcer or wounds caused by mechanical damage or iatrogenic injury. Exclusion Criteria: Patient refusal. Patient has a documented history of allergy or sensitivity to any of the animal products used in preparation of skin substitute. These products include bovine blood, bovine collagen, and bovine collagenase. Patient has a documented history of allergy or sensitivity to any of the antimicrobials or reagents used in preparation and application of skin substitute including the irrigation solution used before and after grafting. Patient has a current diagnosis of an invasive burn wound infection in unexcised burn wound. Patient has tunnels or sinus tracts that cannot be completely debrided. Serious primary diseases of the liver, kidney and hematopoietic system, Abnormal liver function(glutamic-pyruvic transaminase(ALT), glutamicoxalacetic transaminase (AST) is 2 times higher than the normal value), creatinine(Cr) is higher than the upper limit of the normal value. Other clinical trial participants within 3 months. A random blood sugar reading >/=450 mg/dL. Investigators judge other conditions not suitable for inclusion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medical Collagen Membrane with MSC<br>Applications of medical collagen membrane with umbilical cord derived mesenchymal stem cells (MSC). | Device: Medical Collagen Membrane with MSC<br> <br> |
| Active Comparator: Medical Collagen Membrane<br>Application of medical collagen membrane only. | Device: Medical Collagen Membrane<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events that are related to study treatment and associated with the grafting site |  | Up to Month 36 after the last grafting day | 
| Percentage of wound closure as determined |  | Up to Month 3 after the last grafting day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar outcome assessment |  | Up to Month 36 after the last grafting day | 
| Incidence of contracture release or revision surgeries |  | Up to Month 36 after the last grafting day | 
| Incidence of increased temperature sensitivity |  | Up to Month 36 after the last grafting day | 
| Incidence of paresthesias, pain, dulling of sensation assessed |  | Up to Month 36 after the last grafting day | 
| Incidence and severity of infections at grafting sites |  | Up to Month 6 after the last grafting day | 
| Incidence of all adverse events |  | Up to Month 36 after the last grafting day | 
| Percentage area of re-grafting as determined |  | Up to Month 6 after the last grafting day |