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

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

Study Overview

• Status: Unknown
• Conditions: Chronic Wounds
• Intervention / Treatment: Drug: Antria Cell Preparation Process

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Leonard E Maliver, MD; Phone Number: 7243490520 7243490520; Email: lmaliver@antria.org
• Study Contact Backup: Name: Sarah C Boyer, MS, MA; Phone Number: 7243490520 7243490520; Email: sboyer@antria.org

Study Locations

• United States
  • Pennsylvania
    • Indiana, Pennsylvania, United States, 15701
      • Recruiting
      • Indiana Regional Medical Center
      • Contact: Leonard E Maliver, MD; Phone Number: 724-349-0520

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Antria Cell Preparation Process; Safety will be evaluated by collection of vital signs, EKG, patient surveys, and assessments	Drug: Antria 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: Other Names: SVF

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Antria
• Investigators: Principal Investigator: Leonard E Maliver, MD, Antria Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2017
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: May 24, 2017
• First Submitted That Met QC Criteria: March 18, 2019
• First Posted (ACTUAL): March 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 20, 2019
• Last Update Submitted That Met QC Criteria: March 18, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Lipoaspirate; Autologous Adult Stem Cell; Non-healing Wounds; Stomal Vasular Fraction
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: CW0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No