search
Back to results

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

Primary Purpose

Wounds, Diabetic Foot Ulcers, Burns

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Medical Collagen Membrane with MSC
Medical Collagen Membrane
Sponsored by
South China Research Center for Stem Cell and Regenerative Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wounds

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Medical Collagen Membrane with MSC

    Medical Collagen Membrane

    Arm Description

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

    Application of medical collagen membrane only.

    Outcomes

    Primary Outcome Measures

    Incidence of adverse events that are related to study treatment and associated with the grafting site
    Percentage of wound closure as determined

    Secondary Outcome Measures

    Scar outcome assessment
    Incidence of contracture release or revision surgeries
    Incidence of increased temperature sensitivity
    Incidence of paresthesias, pain, dulling of sensation assessed
    Incidence and severity of infections at grafting sites
    Incidence of all adverse events
    Percentage area of re-grafting as determined

    Full Information

    First Posted
    January 31, 2016
    Last Updated
    January 31, 2016
    Sponsor
    South China Research Center for Stem Cell and Regenerative Medicine
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02672280
    Brief Title
    Safety and Exploratory Efficacy Study of Collagen Membrane With Mesenchymal Stem Cells in the Treatment of Skin Defects
    Acronym
    SEESCMMSCTSD
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2016 (undefined)
    Primary Completion Date
    December 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    South China Research Center for Stem Cell and Regenerative Medicine

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Wounds, Diabetic Foot Ulcers, Burns

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Medical Collagen Membrane with MSC
    Arm Type
    Experimental
    Arm Description
    Applications of medical collagen membrane with umbilical cord derived mesenchymal stem cells (MSC).
    Arm Title
    Medical Collagen Membrane
    Arm Type
    Active Comparator
    Arm Description
    Application of medical collagen membrane only.
    Intervention Type
    Device
    Intervention Name(s)
    Medical Collagen Membrane with MSC
    Intervention Type
    Device
    Intervention Name(s)
    Medical Collagen Membrane
    Primary Outcome Measure Information:
    Title
    Incidence of adverse events that are related to study treatment and associated with the grafting site
    Time Frame
    Up to Month 36 after the last grafting day
    Title
    Percentage of wound closure as determined
    Time Frame
    Up to Month 3 after the last grafting day
    Secondary Outcome Measure Information:
    Title
    Scar outcome assessment
    Time Frame
    Up to Month 36 after the last grafting day
    Title
    Incidence of contracture release or revision surgeries
    Time Frame
    Up to Month 36 after the last grafting day
    Title
    Incidence of increased temperature sensitivity
    Time Frame
    Up to Month 36 after the last grafting day
    Title
    Incidence of paresthesias, pain, dulling of sensation assessed
    Time Frame
    Up to Month 36 after the last grafting day
    Title
    Incidence and severity of infections at grafting sites
    Time Frame
    Up to Month 6 after the last grafting day
    Title
    Incidence of all adverse events
    Time Frame
    Up to Month 36 after the last grafting day
    Title
    Percentage area of re-grafting as determined
    Time Frame
    Up to Month 6 after the last grafting day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xuetao Pei, M.D., Ph.D
    Phone
    0086-10-68164807
    Email
    peixuetao@scrm.org.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bowen Zhang, Ph.D
    Phone
    0086-10-66931947
    Email
    zhangbowen@scrm.org.cn

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    17653662
    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.
    Results Reference
    background
    Links:
    URL
    http://link.springer.com/article/10.1007%2Fs11427-007-0069-2
    Description
    Related Info

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs