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

NCT ID: NCT03882983

Last Updated: 2019-03-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2022-12-31

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.

Conditions

Chronic Wounds

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Antria Cell Preparation Process

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

Group Type: EXPERIMENTAL

Antria Cell Preparation Process

Intervention Type: DRUG

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:

Interventions

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:

Intervention Type: DRUG

Other Intervention Names

SVF

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Antria

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leonard E Maliver, MD

Role: PRINCIPAL_INVESTIGATOR

Antria Inc.

Locations

Indiana Regional Medical Center

Indiana, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Leonard E Maliver, MD

Role: CONTACT

lmaliver@antria.org

7243490520 ext. 7243490520

Sarah C Boyer, MS, MA

Role: CONTACT

sboyer@antria.org

7243490520 ext. 7243490520

Facility Contacts

Leonard E Maliver, MD

Role: primary

724-349-0520

Other Identifiers

CW0001

Identifier Type: -

Identifier Source: org_study_id