Safety Analysis of Implantation of Stromal Vascular Fraction

NCT ID: NCT03226093

Last Updated: 2017-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

676 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2017-06-01

Brief Summary

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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

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Conditions

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Safety Issues

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stromal Vascular Fraction

Isolation of SVF from fat tissue for re-administration into the same patient

Group Type EXPERIMENTAL

Stromal Vascular Fraction

Intervention Type PROCEDURE

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

Interventions

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Stromal Vascular Fraction

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

97 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bioheart, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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ADI-SS-001

Identifier Type: -

Identifier Source: org_study_id

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