United States v. US Stem Cell Clinic, LLC

United States v. US Stem Cell Clinic, LLC

Opinion

 [*1282]  ORDER ON MOTIONS FOR SUMMARY JUDGMENT

THIS CAUSE is before the Court upon Plaintiff's Motion Summary Judgment ("Plaintiff's Motion"), D.E. 42, and Defendants' Motion for Summary Judgment ("Defendants' Motion" and together with Plaintiff's Motion, the "Motions"). D.E. 41. The Court has reviewed the Motions, the pertinent portions of the record and is otherwise fully advised in the premises. For the reasons discussed infra, Plaintiff's Motion is GRANTED and Defendants' Motion is DENIED.

I. Factual Background

Unless otherwise indicated, the following facts are undisputed.

A. Defendants and their Operations

Defendants¹ US Stem Cell Clinic, LLC (the "Clinic") and US Stem Cell, Inc. are Florida corporations. D.E. 42-1 ¶¶ 1-2; D.E. 50-1 ¶¶ 1-2. The Defendants are engaged in the business of providing a therapeutic treatment in which a patient's adipose tissue (fat) is extracted, processed to isolate certain stem cells, and injected back into the same patient to treat a range of neurological, autoimmune, and orthopedic illnesses. D.E. 42-1 ¶¶ 5-8; [**4]  D.E. 50-1 ¶¶ 5-8. Defendant Kristin Comella ("Comella") is the Chief Scientific Officer of both the Clinic and US Stem Cell, Inc. D.E. 26 ¶ 22.

B. Stromal Vascular Fraction & Defendants' Procedure

Adipose tissue is a connective tissue composed of clusters of adipocyte cells (fat cells), surrounded by a reticular fiber network, interspersed with blood vessels and  [*1283]  white blood cells. D.E. 42-1 ¶¶ 11-12; D.E. 50 ¶¶ 11-12; D.E. 42-4 ¶ 23; D.E. 45-5 at 6. Adipose tissue also contains stem cells including stromal and vascular stem cells known as the "stromal vascular fraction." ("SVF"). Id.

At the Clinic, Defendants utilize a multi-step procedure to separate the SVF from the other component cells of the adipose tissue. First, healthcare professionals working for Defendants extract a patient's adipose tissue via a "tumescent liposuction" procedure. D.E. 42 ¶ 9; D.E. 50-1 ¶ 9. Then, a "cell wash solution" is added to the extracted adipose tissue to remove blood cells. D.E. 45-2 at 8. This cell wash solution is purchased from manufacturers outside of Florida and is labelled "not for human therapeutic use." D.E. 50-1 ¶ 16; D.E. 53-1 at 10. Next, a solution containing a collagenase enzyme is added [**5]  to the adipose tissue; this digests the collagen and fiber network connecting the cells in the adipose tissue. D.E. 1 ¶ 10; D.E. 26 ¶ 10; D.E. 42-4 ¶ 19. The enzyme solution is purchased from a manufacturer located outside of Florida. Id.; D.E. 53-1 at 18-19. Next, the tissue and enzyme mixture is centrifuged for five minutes, which separates the adipocytes and other components from the SVF. D.E. 42-4 ¶ 19; D.E. 45-2 at 8, 23-24. Then, to further isolate the SVF from the enzymatically-digested components of the adipose tissue, the mixture is filtered via a strainer, which allows only the SVF to pass through. D.E. 42-4 ¶ 19; D.E. 45-2 at 8, 25-26. The mixture is then centrifuged again to concentrate it and is combined with a platelet-rich plasma solution or saline. D.E. 42-4 at 8; D.E. 45-2 at 31. This solution, now composed almost exclusively of SVF, is transferred to a syringe to be injected into the patient on the same day it is extracted. Id.

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