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

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.

Study Overview

• Status: Unknown
• Conditions: Burns; Diabetic Foot Ulcers; Wounds
• Intervention / Treatment: Device: Medical Collagen Membrane with MSC; Device: Medical Collagen Membrane

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Xuetao Pei, M.D., Ph.D; Phone Number: 0086-10-68164807; Email: peixuetao@scrm.org.cn
• Study Contact Backup: Name: Bowen Zhang, Ph.D; Phone Number: 0086-10-66931947; Email: zhangbowen@scrm.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: South China Research Center for Stem Cell and Regenerative Medicine

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: January 31, 2016
• First Submitted That Met QC Criteria: January 31, 2016
• First Posted (Estimate): February 3, 2016

Study Record Updates

• Last Update Posted (Estimate): February 3, 2016
• Last Update Submitted That Met QC Criteria: January 31, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: UCMSC-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED