Safety Analysis of Implantation of Stromal Vascular Fraction

Not Applicable

Completed

• Conditions: Safety Issues
• Interventions: Procedure: Stromal Vascular Fraction

• Registration Number: NCT03226093
• Lead Sponsor: Bioheart, Inc.

Brief Summary

Stromal vascular fraction (SVF) can be isolated from fat (adipose) tissue in an outpatient in-clinic procedure. Platelet rich plasma (PRP) can be isolated from peripheral blood. The SVF includes a variety of different cells and growth factors where the adipocyte (fat cell) population has been removed. The use of SVF in the clinic for a variety of indications is analyzed for incidences of safety and tolerability.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2017-01-01
• Study Completion: 2017-06-01
• Status Verified: 2017-07
• Study First Submitted: 2017-07-20
• Study First Submitted QC: 2017-07-20
• Last Update Submitted: 2017-07-20
• Study First Posted: 2017-07-21
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 676

Inclusion Criteria

• Age between 15 and 97
• Able and willing to give written informed consent
• Up to date on all age and gender appropriate cancer screening

Exclusion Criteria

• Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
• Life expectancy < 6 months due to concomitant illnesses.
• Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
• Active infectious disease patients known to have tested positive for HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis. Will have an expert consulted as to patient eligibility based on the patient's infectious status
• Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stromal Vascular Fraction	Stromal Vascular Fraction	Isolation of SVF from fat tissue for re-administration into the same patient

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	12 months	Collection of adverse events