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

Phase 1

• Conditions: Chronic Wounds
• Interventions: Drug: Antria Cell Preparation Process

• Registration Number: NCT03882983
• Lead Sponsor: Antria

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.

Study Timeline

• Study First Submitted: 2017-05-24
• Study Start: 2017-09-01
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-18
• Last Update Submitted: 2019-03-18
• Study First Posted: 2019-03-20
• Last Update Posted: 2019-03-20
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Antria Cell Preparation Process	Antria Cell Preparation Process	Safety will be evaluated by collection of vital signs, EKG, patient surveys, and assessments

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Indiana Regional Medical Center; 🇺🇸 Indiana, Pennsylvania, United States