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

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ClinicalTrials.gov Identifier: NCT02672280
Recruitment Status : Unknown
Verified January 2016 by South China Research Center for Stem Cell and Regenerative Medicine.
Recruitment status was:  Not yet recruiting
First Posted : February 3, 2016
Last Update Posted : February 3, 2016
Sponsor:
Information provided by (Responsible Party):
South China Research Center for Stem Cell and Regenerative Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Wounds Diabetic Foot Ulcers Burns Device: Medical Collagen Membrane with MSC Device: Medical Collagen Membrane Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Percentage of wound closure as determined [ Time Frame: Up to Month 3 after the last grafting day ]

Secondary Outcome Measures :
  1. Scar outcome assessment [ Time Frame: Up to Month 36 after the last grafting day ]
  2. Incidence of contracture release or revision surgeries [ Time Frame: Up to Month 36 after the last grafting day ]
  3. Incidence of increased temperature sensitivity [ Time Frame: Up to Month 36 after the last grafting day ]
  4. Incidence of paresthesias, pain, dulling of sensation assessed [ Time Frame: Up to Month 36 after the last grafting day ]
  5. Incidence and severity of infections at grafting sites [ Time Frame: Up to Month 6 after the last grafting day ]
  6. Incidence of all adverse events [ Time Frame: Up to Month 36 after the last grafting day ]
  7. Percentage area of re-grafting as determined [ Time Frame: Up to Month 6 after the last grafting day ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672280


Contacts
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Contact: Xuetao Pei, M.D., Ph.D 0086-10-68164807 peixuetao@scrm.org.cn
Contact: Bowen Zhang, Ph.D 0086-10-66931947 zhangbowen@scrm.org.cn

Sponsors and Collaborators
South China Research Center for Stem Cell and Regenerative Medicine
More Information
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Additional Information:

Publications:

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Responsible Party: South China Research Center for Stem Cell and Regenerative Medicine
ClinicalTrials.gov Identifier: NCT02672280    
Other Study ID Numbers: UCMSC-3
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
 Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases