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

Antria1 site in 1 country40 target enrollmentSeptember 1, 2017

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 1, 2017

End Date

December 2022

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Antria

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Female or Male, Age 18 years or older
•Subjects that are diagnosed with one or more chronic wounds.
•Able to understand and provide written and verbal informed consent

Exclusion Criteria

•Currently taking or have taken NSAIDs within last two weeks or corticosteroids within the last six weeks prior to screening.
•Diagnosis of any of the following medical conditions:
•Active malignancy (diagnosed within 5 years), except for treated non-melanoma skin cancer or other non-invasive or in-situ neoplasm (e.g. cervical cancer)
•Active infection (other than their wound)
•Subjects who are unlikely to comply with the protocol (e.g., uncooperative attitude, inability to return for subsequent visits, dementia, and/or otherwise considered by the Investigator to be unlikely to complete the study)
•Subjects with a known drug or alcohol dependence within the past 12 months as judged by the Investigator
•Any other disease condition or laboratory results that in the opinion of the investigator may be clinically significant and render the subject inappropriate for the study procedure(s), may alter the accuracy of study results, or increase the risk for subjects.
•Subjects with life-expectancies less than 12 months
•Subjects with known collagenase allergies
•Pregnant females On radiotherapy or chemotherapy agents

Arms & Interventions

Antria Cell Preparation Process

Safety will be evaluated by collection of vital signs, EKG, patient surveys, and assessments

Intervention: Antria Cell Preparation Process

Outcomes

Primary Outcomes

Bates-Jensen Wound Assessment

Time Frame: 1 year

This assessment focuses on analysis wounds with regards to the following information: size, depth, edges, undermining, necrotic tissue type, necrotic tissue amount, exudate type, exudate amount, skin color surrounding the wound, peripheral tissue edema and induration, granulation tissue, and epithelialization. Each item will be measured on a scale 1-5. A score of 1 will indicate least severe and a score of 5 will indicate the most severe.