Safety Analysis of Implantation of Stromal Vascular Fraction

Bioheart, Inc.676 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

676

Conditions

Safety Issues

Interventions

Stromal Vascular FractionPROCEDURE

The fat was separated via centrifuge to isolate the SVF and the cells were delivered intraarticularly, intravenously, intrathecally, or intradiscally directly into the same patient

Eligibility

Sex: ALLMin age: 15 YearsMax age: 97 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Collection of adverse events

Time frame: 12 months

Data from ClinicalTrials.gov

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