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

Chronic Wounds Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03882983
• Other study ID #: CW0001
• Status: Recruiting
• Phase: Phase 1
• Start date: September 1, 2017
• Est. completion date: December 2022

Study information

• Verified date: March 2019
• Source: Antria
• Contact: Leonard E Maliver, MD
• Phone: 7243490520
• Email: lmaliver[@]antria.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Wounds
• Wounds and Injuries

Intervention

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:

Locations

Country	Name	City	State
United States	Indiana Regional Medical Center	Indiana	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Antria

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Digital Picture of wound	Digital pictures of subject's wounds pre-treatment and post-treatment will be performed to show changed from baseline assessments.	1 year