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

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ClinicalTrials.gov Identifier: NCT03882983
Recruitment Status : Recruiting
First Posted : March 20, 2019
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Chronic Wounds Drug: Antria Cell Preparation Process Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Safety Study Using Stromal Vascular Fraction From Lipoaspirate in the Treatment of Chronic Non-healing Wounds
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


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 Name: SVF




Primary Outcome Measures :
  1. Bates-Jensen Wound Assessment [ Time Frame: 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 :
  1. Digital Picture of wound [ Time Frame: 1 year ]
    Digital pictures of subject's wounds pre-treatment and post-treatment will be performed to show changed from baseline assessments.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03882983


Contacts
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Contact: Leonard E Maliver, MD 7243490520 ext 7243490520 lmaliver@antria.org
Contact: Sarah C Boyer, MS, MA 7243490520 ext 7243490520 sboyer@antria.org

Locations
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United States, Pennsylvania
Indiana Regional Medical Center Recruiting
Indiana, Pennsylvania, United States, 15701
Contact: Leonard E Maliver, MD    724-349-0520      
Sponsors and Collaborators
Antria
Investigators
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Principal Investigator: Leonard E Maliver, MD Antria Inc.

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Responsible Party: Antria
ClinicalTrials.gov Identifier: NCT03882983     History of Changes
Other Study ID Numbers: CW0001
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Antria:
Autologous Adult Stem Cell
Lipoaspirate
Non-healing Wounds
Stomal Vasular Fraction
Additional relevant MeSH terms:
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Wounds and Injuries