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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Wounds

Intervention / Treatment
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* Drug: Antria Cell Preparation Process


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antria Cell Preparation Process<br>Safety will be evaluated by collection of vital signs, EKG, patient surveys, and assessments | Drug: Antria Cell Preparation Process<br>* 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:<br>* Other names: SVF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bates-Jensen Wound Assessment | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Digital Picture of wound | Digital pictures of subject's wounds pre-treatment and post-treatment will be performed to show changed from baseline assessments. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autologous Adult Stem Cell, Lipoaspirate, Non-healing Wounds, Stomal Vasular Fraction