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J Clin Med Res. 2017 Nov;9(11):935-942. doi: 10.14740/jocmr3187w. Epub 2017 Oct 2.

Safety Analysis of Autologous Stem Cell Therapy in a Variety of Degenerative Diseases and Injuries Using the Stromal Vascular Fraction.

Author information

1
US Stem Cell, Inc., 13794 NW 4th Street, Suite 212, Sunrise, FL 33325, USA.
2
Panama College of Cell Science, 3rd Floor, C&H Towers Corner of Great Marlboro and Great George Streets Roseau, 00152, Commonwealth of Dominica.
3
US Stem Cell Clinic, 12651 Sunrise Blvd, Suite 104, Sunrise, FL 33323, USA.
4
NSI Stem Cell, 3118 Gulf to Bay Blvd, Suite 310, Clearwater, FL 33759, USA.
5
Mallory Family Wellness, 1548 North Boise Ave., Loveland, CO 80538, USA.
6
New Life Medical Group, 15 Stonebridge, Jackson, TN 38305, USA.

Abstract

BACKGROUND:

Stem cells from adipose tissue offer a novel therapy for patients with damaged tissue. Stromal vascular fraction (SVF) injected into patients may reduce inflammation, promote healing, and repair damaged/scarred tissue. SVF can be isolated from fat (adipose) tissue in an outpatient procedure. The SVF population includes mesenchymal stem cells (MSCs), pericytes, endothelial/progenitor cells, fibroblasts and growth factors where the adipocyte (fat cell) population has been removed. Here we describe the use of SVF in the clinic for degenerative diseases in orthopedics, neurological conditions and systemic conditions in 676 patients.

METHODS:

This study demonstrated the strong safety profile from a multi-center analysis of SVF injection in treating various diseases. Approximately 60 mL of fat tissue was removed from the abdomen or flanks using a local tumescent liposuction 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. All subjects were monitored for adverse events.

RESULTS:

The procedure demonstrates exceptional patient safety, and the study underscores the safety of autologous stem cell therapy in general. Few adverse events were reported and were overwhelmingly of mild and transient nature, such as the expected soreness at the site of liposuction and occasional headache.

CONCLUSION:

The three deaths reported were most likely not related to the treatment but instead to the underlying disease. Our study demonstrates a strong safety profile with low complication rates.

KEYWORDS:

Adipose tissue; Adipose-derived stromal/stem cells; Cell therapy; Mesenchymal stem cells; Platelet rich plasma; Regenerative medicine; Stem cells; Stromal vascular fraction

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