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

Phase 1

• Conditions: Burns; Wounds; Diabetic Foot Ulcers
• Interventions: Device: Medical Collagen Membrane with MSC; Device: Medical Collagen Membrane

• Registration Number: NCT02672280
• Lead Sponsor: South China Research Center for Stem Cell and Regenerative Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-01
• Study First Submitted: 2016-01-31
• Study First Submitted QC: 2016-01-31
• Last Update Submitted: 2016-01-31
• Study First Posted: 2016-02-03
• Last Update Posted: 2016-02-03
• Study Start: 2016-05
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medical Collagen Membrane with MSC	Medical Collagen Membrane with MSC	Applications of medical collagen membrane with umbilical cord derived mesenchymal stem cells (MSC).
Medical Collagen Membrane	Medical Collagen Membrane	Application of medical collagen membrane only.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Incidence of all adverse events	Up to Month 36 after the last grafting day
Scar outcome assessment	Up to Month 36 after the last grafting day
Incidence of increased temperature sensitivity	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 contracture release or revision surgeries	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
Percentage area of re-grafting as determined	Up to Month 6 after the last grafting day