Stem Cells In Wound Healing With Collagen Matrix as a Carrier

NCT02314416 | Withdrawn Phase 4 DMC

• 1 other identifier: 611757
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Wounds

Keywords

wounds, stem cells, collagen matrix, maturation

Outcome Measures

Primary Outcomes (1)

• Maturation of Collagen Matrix (Changes in color of collagen matrix from tan to white to vanilla, which signifies vascularity)

  Changes in color of Collagen Matrix from tan to white to vanilla, which signifies vascularity

  Days 3, 5, 7, 14, 21 and 28 after treatment

Secondary Outcomes (1)

• Complete Wound Healing (Change is size of wound in millimeters)

  Days 3, 4, 7, 14, 21 and 28 after treatment

Study Arms (2)

Standard Treatment

ACTIVE COMPARATOR

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

Amniotic Stem Cells and Collagen Matrix

EXPERIMENTAL

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

Interventions

Amniotic Stem Cells and Collagen Matrix BIOLOGICAL

Nucel will be applied in between two pieces of collagen matrix'. The NuCel-impregnated collagen matrix will be placed over a clean, debrided wound.

Also known as: NuCel

Amniotic Stem Cells and Collagen Matrix; Standard Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Augusta University: lead
• NuTech Medical, Inc: collaborator

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Edmond Ritter, MD

  Professor of Plastic Surgery and Reconstructive Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Plastic and Reconstructive Surgery

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 11, 2014
• Study Start: May 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 27, 2015

Record last verified: 2015-05