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
Sponsored by
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
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
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
No
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
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.
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
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.
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
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
Email
lmaliver@antria.org
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah C Boyer, MS, MA
Phone
7243490520
Ext
7243490520
Email
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
No
Learn more about this trial
Stromal Vascular Fraction From Lipoaspirate to Treatment of Chronic Non-healing Wound
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