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

Last updated: March 18, 2019
Sponsor: Antria
Overall Status: Active - Recruiting

Phase

1

Condition

Pressure Ulcers

Treatment

N/A

Clinical Study ID

NCT03882983
CW0001
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Currently taking or have taken NSAIDs within last two weeks or corticosteroids withinthe 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-melanomaskin cancer or other non-invasive or in-situ neoplasm (e.g. cervical cancer)

  • Active infection (other than their wound)

  1. Subjects who are unlikely to comply with the protocol (e.g., uncooperative attitude,inability to return for subsequent visits, dementia, and/or otherwise considered bythe Investigator to be unlikely to complete the study)

  2. Subjects with a known drug or alcohol dependence within the past 12 months as judgedby the Investigator

  3. Any other disease condition or laboratory results that in the opinion of theinvestigator may be clinically significant and render the subject inappropriate forthe study procedure(s), may alter the accuracy of study results, or increase the riskfor subjects.

  4. Subjects with life-expectancies less than 12 months

  5. Subjects with known collagenase allergies

  6. Pregnant females On radiotherapy or chemotherapy agents

Study Design

Total Participants: 40
Study Start date:
September 01, 2017
Estimated Completion Date:
December 31, 2022

Study 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.

Connect with a study center

  • Indiana Regional Medical Center

    Indiana, Pennsylvania 15701
    United States

    Active - Recruiting

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