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



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:3/22/2019
Start Date:September 1, 2017
End Date:December 2022
Contact:Leonard E Maliver, MD
Email:lmaliver@antria.org
Phone:7243490520

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

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

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.

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
We found this trial at
1
site
Indiana, Pennsylvania 15701
Phone: 724-349-0520
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Indiana, PA
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