Stromal Vascular Fraction From Lipoaspirate to Treatment of Chronic Non-healing Wound
NCT03882983 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2019-03-20
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
Conditions
- Chronic Wounds
Interventions
- 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:
Sponsors & Collaborators
-
Antria
lead INDUSTRY
Principal Investigators
-
Leonard E Maliver, MD · Antria Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-09-01
- Primary Completion
- 2022-12-31
- Completion
- 2022-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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