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

NCT ID: NCT02672280

Last Updated: 2016-02-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-12-31

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.

Conditions

Wounds; Diabetic Foot Ulcers; Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Medical Collagen Membrane with MSC

Applications of medical collagen membrane with umbilical cord derived mesenchymal stem cells (MSC).

Group Type: EXPERIMENTAL

Medical Collagen Membrane with MSC

Intervention Type: DEVICE

Medical Collagen Membrane

Application of medical collagen membrane only.

Group Type: ACTIVE_COMPARATOR

Medical Collagen Membrane

Intervention Type: DEVICE

Interventions

Medical Collagen Membrane with MSC

Intervention Type: DEVICE

Medical Collagen Membrane

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South China Research Center for Stem Cell and Regenerative Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Xuetao Pei, M.D., Ph.D

Role: CONTACT

peixuetao@scrm.org.cn

0086-10-68164807

Bowen Zhang, Ph.D

Role: CONTACT

zhangbowen@scrm.org.cn

0086-10-66931947

References

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.

Reference Type: BACKGROUND

PMID: 17653662 (View on PubMed)

Related Links

http://link.springer.com/article/10.1007%2Fs11427-007-0069-2

Related Info

Other Identifiers

UCMSC-3

Identifier Type: -

Identifier Source: org_study_id