NCT03882983

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2017

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

March 20, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 20, 2019

Status Verified

March 1, 2019

Enrollment Period

5.3 years

First QC Date

May 24, 2017

Last Update Submit

March 18, 2019

Conditions

Chronic Wounds

Keywords

Autologous Adult Stem CellLipoaspirateNon-healing WoundsStomal Vasular Fraction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Digital Picture of wound

    1 year

Study Arms (1)

Antria Cell Preparation Process

EXPERIMENTAL

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

Drug: Antria Cell Preparation Process

Interventions

Antria Cell Preparation ProcessDRUG

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:

Also known as: SVF
Antria Cell Preparation Process

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana Regional Medical Center

Indiana, Pennsylvania, 15701, United States

RECRUITING

Study Officials

  • Leonard E Maliver, MD

    Antria Inc.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonard E Maliver, MD

CONTACT

7243490520lmaliver@antria.org

Sarah C Boyer, MS, MA

CONTACT

7243490520sboyer@antria.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2017

First Posted

March 20, 2019

Study Start

September 1, 2017

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

March 20, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)