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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antria Cell Preparation Process | Experimental | Safety will be evaluated by collection of vital signs, EKG, patient surveys, and assessments |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antria Cell Preparation Process | Drug | Biological/Vaccine: Stromal Vascular Fraction The SVF obtained from adipose tissue will be added to the graft Other Names:
|
| 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 |
| 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 |
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Inclusion Criteria:
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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leonard E Maliver, MD | Contact | 7243490520 | 7243490520 | lmaliver@antria.org |
| Sarah C Boyer, MS, MA | Contact | 7243490520 | 7243490520 | sboyer@antria.org |
| Name | Affiliation | Role |
|---|---|---|
| Leonard E Maliver, MD | Antria Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana Regional Medical Center | Recruiting | Indiana | Pennsylvania | 15701 | United States |
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