NCT03882983

Stromal Vascular Fraction From Lipoaspirate to Treatment of Chronic Non-healing Wound

A Phase I Safety Study Using Stromal Vascular Fraction From Lipoaspirate in the Treatment of Chronic Non-healing Wounds

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Antria · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a Phase I, open-label, single arm study to demonstrate the safety of Antria Cell Preparation Process during fat grafting augmented with autologous adipose derived stromal vascular fraction to demonstrate the safety and efficacy of administration of SVF enriched fat grafting in chronic wounds

Detailed description

This is a Phase I, open-label, single arm study to demonstrate the safety of Antria Cell Preparation Process during fat grafting augmented with autologous adipose derived stromal vascular fraction to demonstrate the safety and efficacy of administration of SVF enriched fat grafting in chronic wounds.

Conditions

• Chronic Wounds

Interventions

Type	Name	Description
DRUG	Antria Cell Preparation Process	Biological/Vaccine: Stromal Vascular Fraction The SVF obtained from adipose tissue will be added to the graft Other Names: * Stromal Vascular Fraction * Adiployx Biological/Vaccine:

Timeline

• Start date: 2017-09-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2019-03-20
• Last updated: 2019-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study