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

Burns Clinical Trial

— SEESCMMSCTSD  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02672280
• Other study ID #: UCMSC-3
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: January 31, 2016
• Last updated: January 31, 2016
• Start date: May 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2016
• Source: South China Research Center for Stem Cell and Regenerative Medicine
• Contact: Xuetao Pei, M.D., Ph.D
• Phone: 0086-10-68164807
• Email: peixuetao[@]scrm.org.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns
• Diabetic Foot
• Diabetic Foot Ulcers
• Wounds

Intervention

Device:
• Medical Collagen Membrane with MSC

• Medical Collagen Membrane

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
South China Research Center for Stem Cell and Regenerative Medicine

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Percentage of wound closure as determined		Up to Month 3 after the last grafting day	No
Secondary	Scar outcome assessment		Up to Month 36 after the last grafting day	No
Secondary	Incidence of contracture release or revision surgeries		Up to Month 36 after the last grafting day	No
Secondary	Incidence of increased temperature sensitivity		Up to Month 36 after the last grafting day	No
Secondary	Incidence of paresthesias, pain, dulling of sensation assessed		Up to Month 36 after the last grafting day	No
Secondary	Incidence and severity of infections at grafting sites		Up to Month 6 after the last grafting day	Yes
Secondary	Incidence of all adverse events		Up to Month 36 after the last grafting day	Yes
Secondary	Percentage area of re-grafting as determined		Up to Month 6 after the last grafting day	No

External Links

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