Stromal Vascular Fraction From Lipoaspirate to Treatment of Chronic Non-healing Wound
Status unconfirmed · Phase 1
Conditions studied: Chronic Wounds
In brief
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
Key facts
- Study ID
- NCT03882983
- Run by
- Antria
- People needed
- 40
- Starts
- 2017-09-01
- Expected to finish
- 2022-12-01
- Last updated by the study team
- 2019-03-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Indiana Regional Medical Center — Indiana, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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