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

Antria

Status and phase: Unknown; Phase 1

Conditions: Chronic Wounds

Treatments: Drug: Antria Cell Preparation Process

Study type: Interventional

Funder types: Industry

Identifiers

NCT03882983

CW0001

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Antria Cell Preparation Process

Experimental group

Description:

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

Treatment:

Drug: Antria Cell Preparation Process