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Stem Cells In Wound Healing With Collagen Matrix as a Carrier

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ClinicalTrials.gov Identifier: NCT02314416
Recruitment Status : Withdrawn
First Posted : December 11, 2014
Last Update Posted : May 27, 2015
Sponsor:
Collaborator:
NuTech Medical, Inc
Information provided by (Responsible Party):
Edmond Ritter, Augusta University

Brief Summary:
The purpose of the study is to use a collagen matrix embedded with amniotic stem cells to speed up the maturation and integration of the collagen matrix in the wound bed and shorten total time needed for wound healing.

Condition or disease Intervention/treatment Phase
Wounds Biological: Amniotic Stem Cells and Collagen Matrix Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stem Cells In Wound Healing With Collagen Matrix as a Carrier
Study Start Date : May 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arm Intervention/treatment
Active Comparator: Standard Treatment
Patients in the Control Arm will receive collagen matrix for wound coverage and standard wound care that will include chemical/surgical debridement (using a topical paste to clean the wound or removing bad tissue using a scalpel or scissors) and dressing care. In addition, they may also have imaging studies (such as x-ray, CAT scan, ultrasound) performed if determined to be necessary by the physician.
Biological: Amniotic Stem Cells and Collagen Matrix
Nucel will be applied in between two pieces of collagen matrix`. The NuCel-impregnated collagen matrix will be placed over a clean, debrided wound.
Other Name: NuCel

Experimental: Amniotic Stem Cells and Collagen Matrix
Patients will receive amniotic stem cells(NuCel) embedded in collagen matrix for wound coverage, and standard wound care that will include chemical/surgical debridement (using a topical paste to clean the wound or removing bad tissue using a scalpel or scissors) and dressing care. In addition, they may also have imaging studies (such as x-ray, CAT scan, ultrasound) performed if determined to be necessary by the physician.
Biological: Amniotic Stem Cells and Collagen Matrix
Nucel will be applied in between two pieces of collagen matrix`. The NuCel-impregnated collagen matrix will be placed over a clean, debrided wound.
Other Name: NuCel




Primary Outcome Measures :
  1. Maturation of Collagen Matrix (Changes in color of collagen matrix from tan to white to vanilla, which signifies vascularity) [ Time Frame: Days 3, 5, 7, 14, 21 and 28 after treatment ]
    Changes in color of Collagen Matrix from tan to white to vanilla, which signifies vascularity


Secondary Outcome Measures :
  1. Complete Wound Healing (Change is size of wound in millimeters) [ Time Frame: Days 3, 4, 7, 14, 21 and 28 after treatment ]
    Change is size of wound in millimeters



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with an acute or chronic would that present for a plastic surgery consultation for wound care.

Exclusion Criteria:

  • Active Smokers,
  • Immunosuppressed patients,
  • nutritionally depleted patients,
  • terminally ill cancer patients,
  • transplant patients,
  • ASA class IV and higher will be excluded

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): NCT02314416


Sponsors and Collaborators
Augusta University
NuTech Medical, Inc
Investigators
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Principal Investigator: Edmond Ritter, MD Professor of Plastic Surgery and Reconstructive Surgery

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Responsible Party: Edmond Ritter, Professor of Plastic and Reconstructive Surgery, Augusta University
ClinicalTrials.gov Identifier: NCT02314416     History of Changes
Other Study ID Numbers: 611757
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015

Keywords provided by Edmond Ritter, Augusta University:
wounds, stem cells, collagen matrix, maturation

Additional relevant MeSH terms:
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Wounds and Injuries