NCT05797688

Adipose-derived Stem Cells to Treat Chronic Wounds.

Use of Autologous Adipose-derived Stem Cell to Treat Chronic Wounds

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Winthrop University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to determine whether autologous, adipose-derived regenerative cells improve the healing of chronic wounds. Ten patients will undergo fat harvest and peri-wound injection of the isolated cells in addition to the standard of care for the treatment of their chronic wound. Wound healing will be followed over 24 weeks.

Detailed description

This study will be an open-label, preliminary, proof-of-concept trial. Ten patients will undergo debridement of their wound per the standard of care currently offered by Winthrop University Hospital along with concurrent fat harvest according to the standard protocols of the Winthrop University Hospital Plastic surgeons. The harvested fat will be immediately processed using an automated system to isolate regenerative cells, including stem cells. This will be followed by same-day subcutaneous injection of the isolated cells into the debrided wound site. The patients will then undergo weekly wound debridements according to the current standard of care treatment protocols. They will be followed weekly for 24 weeks in the outpatient wound clinic and observed for pain, erythema of the injection site, wound infection, edema, fever, bleeding and wound healing as measured by wound size and area. Fat harvest and subcutaneous injection will be repeated 3 months after the initial procedure if the wound has not decreased in size by at least 40%. Patients can undergo a maximum of 2 cycles of fat harvest and cell injection.

Conditions

• Wound of Skin

Interventions

Type	Name	Description
DEVICE	The Celution System	The Celution System will isolate regenerative cells, including stem cells, from fat harvested from the treatment patients.

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-07-01
• Completion: 2017-09-01
• First posted: 2023-04-04
• Last updated: 2023-04-04

Locations

1 site across 1 country: United States