SCIENCE & TECHNOLOGY OVERVIEW

Cells are the living, fundamental building blocks of all tissues and organs and are critical in maintaining homeostasis and restoring function in injury, disease, and aging. Despite this fundamental role and an increasing number of cell therapies in clinical development, few have been approved for clinical use in the United States.

Cytori Cell TherapyTM is being developed as a same-day therapeutic option using a clinical-grade preparation of the patient’s own readily available cells, to repair injured tissue, preserve function, improve quality of life and modify disease progression.

ADIPOSE-BASED CELL THERAPY

Human adipose tissue is an unique reservoir of multiple cell types including stem cells, mesenchymal and endothelial progenitor cells, important leukocyte subtypes, lymphatic cells, pericytes, and vascular smooth muscle cells that can contribute to the healing process. This heterogeneous cell population—also referred to as Adipose-Derived Regenerative Cells or ADRCs—can be used to formulate a number of cellular therapeutics.

Using a patient’s own adipose tissue provides an abundant source of cells that do not elicit a rejection response or require transplantation drugs. Adipose tissue is easily collected via a small liposuction procedure and eliminates the need to more invasively obtain cells from less accessible parts of the body or from other patients. This also eliminates the requirement for cells to be shipped to off-site facilities to grow an adequate dose of cells in a laboratory. Furthermore, as determined in numerous laboratory and clinical tests, therapeutics derived from ADRCs display diverse biologic activity and a favorable risk-benefit profile.

Cytori is not just a leader in the science of cell therapy, we have also spent over a decade developing innovative products and technology to produce the highest quality cell therapy products from a patient’s adipose tissue at the point-of-care in approximately an hour. Cytori continues to build on its scientific and product development strengths to bring Cytori Cell Therapy to the patients who need it.

CYTORI CELL THERAPYTM — MECHANISMS OF ACTION

Cytori Cell Therapy has been shown to exert its therapeutic impact on both acute and chronic conditions via several principal mechanisms of action. One important mechanism is the release of factors in response to stimuli generated by the underlying disease process. This ‘stimulus-response’ phenomenon is a characteristic of living systems and can only be achieved by therapeutics based on living cells. As would be expected of a living system, the precise factors released and mechanisms by which these lead to the therapeutic impact differ by condition.

By way of example, Cytori Cell Therapy responds to an ischemic condition by increasing production of pro-angiogenic factors including VEGF and PlGF.1 This expression is sustained as long as the ischemia is present. Then, as the ischemia is ameliorated the expression of these factors returns to normal while that of other factors is activated. This phasic response is complex and has been shown to occur with a number of factors over the duration of therapeutic action, which can be for days, weeks, and months. Similarly, studies have shown that Cytori Cell Therapy responds to inflammation by expressing factors that modulate the inflammatory process and decrease levels of pro-inflammatory factors at the injury site.3 This includes down-regulation of potent pro-inflammatory factors such as Interleukin 6 (IL-6) and Tumor Necrosis factor (TNF).2,3 As a result, excess inflammation is muted leading to reduced tissue damage and fibrosis.

Research has demonstrated that cells within Cytori Cell Therapy are capable of differentiating to form multiple functional cells types such as chondrocytes4 and smooth muscle cells.5 In this way, the therapy has the potential to improve outcome by replacing cells lost to injury, disease, and daily wear and tear.6

A key feature of living systems is that their response to a stimulus is almost never one-dimensional. Consequently, preclinical studies have shown that Cytori Cell Therapy acts through several mechanisms at the same time with the particular balance of mechanisms being dependent upon the stimuli provided by the disease process.2,3 In this way, Cytori Cell Therapy harnesses the unique attributes of living cells to create enormous potential for healing and repair in a broad range of medical conditions and to do so in a manner that is not achievable by conventional therapeutics.

References:

1Data from internal Cytori reports.
2Feng et al 2010; Nephrol Dial Transplant 25 (12) 3874-84..
3Premaratne et al 2011; J Cardiothoracic Surg. 6: 43
4Dragoo et al 2003; 85 (5) 740-7
5Jack et al 2005; J Urol 174 (5) 2041-5
6Ganey et al 2009; Spine 34 (21) 2297-304

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Adipose-Derived Regenerative Cells impart benefit through multiple mechanisms of action