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

Primary Purpose

Chronic Wounds

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Antria Cell Preparation Process

About this trial

This is an interventional treatment trial for Chronic Wounds focused on measuring Autologous Adult Stem Cell, Lipoaspirate, Non-healing Wounds, Stomal Vasular Fraction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Female or Male, Age 18 years or older
Subjects that are diagnosed with one or more chronic wounds.
Able to understand and provide written and verbal informed consent

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:
- 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)
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

Sites / Locations

Indiana Regional Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Antria Cell Preparation Process

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Digital Picture of wound

Digital pictures of subject's wounds pre-treatment and post-treatment will be performed to show changed from baseline assessments.

Full Information

NCT ID

NCT03882983

First Posted

May 24, 2017

Last Updated

March 18, 2019

Sponsor

Antria

1. Study Identification

Unique Protocol Identification Number

NCT03882983

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2017 (Actual)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Antria

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Wounds

Keywords

Autologous Adult Stem Cell, Lipoaspirate, Non-healing Wounds, Stomal Vasular Fraction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Antria Cell Preparation Process

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Antria Cell Preparation Process

Other Intervention Name(s)

SVF

Intervention Description

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:

Primary Outcome Measure Information:

Title

Bates-Jensen Wound Assessment

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Digital Picture of wound

Description

Digital pictures of subject's wounds pre-treatment and post-treatment will be performed to show changed from baseline assessments.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Female or Male, Age 18 years or older Subjects that are diagnosed with one or more chronic wounds. Able to understand and provide written and verbal informed consent 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: 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) 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Leonard E Maliver, MD

Phone

7243490520

Ext

7243490520

lmaliver@antria.org

First Name & Middle Initial & Last Name or Official Title & Degree

Sarah C Boyer, MS, MA

Phone

7243490520

Ext

7243490520

sboyer@antria.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leonard E Maliver, MD

Organizational Affiliation

Antria Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Indiana Regional Medical Center

City

Indiana

State/Province

Pennsylvania

ZIP/Postal Code

15701

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Leonard E Maliver, MD

Phone

724-349-0520

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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