Clinical trial NCT02672280: Safety and Exploratory Efficacy Study of Collagen Membrane With Mesenchymal Stem Cells in the Treatment of Skin Defects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Wounds
Diabetic Foot Ulcers
Burns
Lead sponsor: South China Research Center for Stem Cell and Regenerative Medicine
Sponsor class: OTHER
First posted: 2016-02-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of adverse events that are related to study treatment and associated with the grafting site
timeFrame: Up to Month 36 after the last grafting day
measure: Percentage of wound closure as determined
timeFrame: Up to Month 3 after the last grafting day
Secondary outcomes:
measure: Scar outcome assessment
timeFrame: Up to Month 36 after the last grafting day
measure: Incidence of contracture release or revision surgeries
timeFrame: Up to Month 36 after the last grafting day
measure: Incidence of increased temperature sensitivity
timeFrame: Up to Month 36 after the last grafting day
measure: Incidence of paresthesias, pain, dulling of sensation assessed
timeFrame: Up to Month 36 after the last grafting day
measure: Incidence and severity of infections at grafting sites
timeFrame: Up to Month 6 after the last grafting day
measure: Incidence of all adverse events
timeFrame: Up to Month 36 after the last grafting day
measure: Percentage area of re-grafting as determined
timeFrame: Up to Month 6 after the last grafting day
Other outcomes:
Locations:
Study officials:
References:
citation: He L, Nan X, Wang Y, Guan L, Bai C, Shi S, Yuan H, Chen L, Liu D, Pei X. Full-thickness tissue engineered skin constructed with autogenic bone marrow mesenchymal stem cells. Sci China C Life Sci. 2007 Aug;50(4):429-37. doi: 10.1007/s11427-007-0069-2.