Chronic Wounds
Conditions
Keywords
Autologous Adult Stem Cell, Lipoaspirate, Non-healing Wounds, Stomal Vasular Fraction
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.
Interventions
DRUGAntria 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:
Sponsors
Antria
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Female or Male, Age 18 years or older 2. Subjects that are diagnosed with one or more chronic wounds. 3. Able to understand and provide written and verbal informed consent
Exclusion criteria
1. Currently taking or have taken NSAIDs within last two weeks or corticosteroids within the last six weeks prior to screening. 2. 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) 3. 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) 4. Subjects with a known drug or alcohol dependence within the past 12 months as judged by the Investigator 5. 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. 6. Subjects with life-expectancies less than 12 months 7. Subjects with known collagenase allergies 8. Pregnant females On radiotherapy or chemotherapy agents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bates-Jensen Wound Assessment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Digital Picture of wound | 1 year | Digital pictures of subject's wounds pre-treatment and post-treatment will be performed to show changed from baseline assessments. |
Countries
United States
Contacts
Primary ContactLeonard E Maliver, MD
Backup ContactSarah C Boyer, MS, MA
Outcome results
None listed