Safety Analysis of Implantation of Stromal Vascular Fraction

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03226093

Enrollment

676

Registered

2017-07-21

Start date

2015-01-01

Completion date

2017-06-01

Last updated

2017-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety Issues

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.

Interventions

PROCEDUREStromal 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 97 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	12 months	Collection of adverse events

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026