Cytori Therapeutics

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Cytori Therapeutics, Inc., of the United States, is a San Diego-based regenerative-medicine company. The company develops and manufactures medical devices that enable the therapeutic use of the adult stem and regenerative cells naturally found within adipose (fat) tissue.

Commercial activities are focused on cosmetic & reconstructive surgery, cell banking, and supplying research tools.

Company history[edit]

Cytori began operations under the name MacroPore in 1996, following the invention of a line of bioresorbable plates and screws for craniofacial surgery based on a polylactic acid polymer technology. By 2000, a commercialization partnership had been formed with Medtronic and two more product lines based on the same technology were developed, one for spinal implants and another adhesion barriers.

Between 2000 and 2002, MacroPore began looking at alternative opportunities in regenerative medicine, including a start-up stem cell company, StemSource, Inc., which commercialized the processing and banking of adult stem cells originating from adipose tissue.

In 2002, MacroPore sold commercialization rights to the craniofacial product line to Medtronic. Later in 2002 MacroPore acquired StemSource and began the development of the Celution System, along with research of clinical applications for the device’s stem and regenerative cell output.

In 2005, MacroPore changed its name to Cytori and entered into a joint venture with Olympus Corporation. The Olympus-Cytori Joint Venture is a collaboration to develop and manufacture the future generations of the Celution System.

Core technology: the Celution System[edit]

The Celution System is a medical device that enables bedside access to adult adipose-derived stem and regenerative cells (ADRCs) by automating and standardizing the extraction, washing, and concentration of a patient’s own ADRCs for present and future clinical use.

The Celution System is being used in cosmetic and reconstructive surgery in Europe and Japan and is being investigated for additional potential applications including cardiovascular disease, stress urinary incontinence, kidney disease and liver disease. In 2013, Lorem Vascular exclusively licensed this technology for a period of 30 years for commercialization in China, Hong Kong, Malaysia, Singapore and Australia.[1]

Celution was CE Marked in January 2006 for extraction and concentration of stem and regenerative cells from adipose tissue for autologous re-implantation or reinfusion. The Celution System is not available in the United States. Cytori is working with the U.S. Food & Drug Administration to bring the Celution technology to the United States.

Cell source[edit]

Adipose tissue, most commonly obtained through a standard liposuction procedure, is the richest known source of adult stem and regenerative cells in the body.[2] The Celution System processes autologous adipose tissue, extracting a mixed cell population without cell culture. The stem and regenerative cells that are found naturally within adipose tissue include stem cells, endothelial progenitor cells, tissue resident macrophages, microvascular cells and smooth muscle cells.

The stem and regenerative cells that are extracted using the Celution System are not derived from embryos.

Cosmetic and reconstructive surgery[edit]

The Celution System was introduced into the European and Asia-Pacific cosmetic and reconstructive surgery market in 2008. Since that time, physicians in Europe and Japan have been using ADRCs to enrich fat grafts for a number of cosmetic applications including breast reconstruction, breast augmentation, facial rejuvenation and buttock augmentation, among others.

RESTORE I[edit]

RESTORE I was an independent Japanese study that examined reconstruction of partial mastectomy breast defects using ADRCs isolated using the Celution System. The 21 patient study was found to be safe and well tolerated in all patients. The study showed a high (79%) level of patient satisfaction with the final outcome.[3]

RESTORE 2[edit]

Following the promising results of RESTORE I, Cytori launched its own European breast reconstruction post-marketing study, named RESTORE 2, in June 2008. The 70 patient study was designed to assess patient and physician satisfaction, improvement in overall breast deformity, imaging, quality of life, and safety among other measures. The study completed enrollment in November 2009, with all patients to be followed up at both six and 12 months.

Six month interim results on 32 patients were presented at the 32nd Annual San Antonio Breast Cancer Symposium on December 12, 2009. In addition to reinforcing the safety of the procedure, the RESTORE 2 study showed that 73% of patients and 82% of physicias were satisfied with the outcome of the procedure.[4]

Fat grafting[edit]

In addition to Celution, Cytori has developed the PureGraft System which allows the physician to wash and purify the fat tissue before reinjection into the same patient, standardizing the fat graft preparation process.

Cytori received a 510(k) for market clearance of the PureGraft System in January 2010 for use in aesthetic body contouring using autologous fat grafts.[5] In addition to the PureGraft System, Cytori has developed the Celbrush, a precision fat graft delivery tool.

Cardiovascular disease[edit]

Cytori is sponsoring two European safety and feasibility studies for the treatment of cardiovascular disease using ADRCs extracted using the Celution System.

APOLLO[edit]

Cytori’s APOLLO study was designed to evaluate the use of ADRCs in the treatment of patients who have undergone myocardial infarctions. In March 2009, the study’s Steering Committee and the data safety and monitoring board (DSMB) deemed that the safety and feasibility goals of the study had been after the enrollment of 12 patients. Primary outcomes for the study will be assessed at the six month follow up.

PRECISE[edit]

Cytori’s PRECISE study evaluates the use of ADRCs to treat patients suffering from chronic myocardial ischemia. Enrollment in the trial was completed in May 2009 with the enrollment of 27 patients. Primary outcomes of the study will be assessed at six months.

StemSource and stem cell banking[edit]

Cytori has also developed StemSource, automated laboratory equipment for tissue processing and cell extraction system for research use. The StemSource equipment is available worldwide.

Stem cell banking[edit]

In addition to use in laboratory research, StemSource is the centerpiece of Cytori’s StemSource Cell Bank platform for cryopreservation and storage of a patients’ adult stem and regenerative cells (ADRC’s). The StemSource Cell Bank allows hospitals and companies to offer their patients the option of harvesting, preparation and storage of their adipose tissue or their processed ADRC’s.

Once the adipose tissue is extracted and prepared using the StemSource equipment, the storage technology freezes the tissue/cells at -196 degrees Celsius, which drastically slows the metabolism of the cells, preventing future aging or deterioration and preserving them for potential future use, should clinical applications be approved by governmental authorities.


Other research and applications[edit]

The Celution System is being used in Japan and Europe as tool for independent investigation and development of additional therapeutic uses of ADRCs.

Some of these investigations include stress urinary incontinence, wound healing, liver insufficiency, renal failure and peripheral artery disease.

References[edit]

  1. ^ "Lorem Vascular Licenses Cytori Cell Therapy". Gen. Eng. Biotechnol. News (paper) 33 (21). December 2013. p. 10. 
  2. ^ Fraser,J.K., Wulur,I., Alfonso,Z. & Hedrick,M.H. Fat tissue: an underappreciated source of stem cells for biotechnology. TrendsBiotechnoly. 24, 150-154 (2006).
  3. ^ Kitamura, Kaoru, et al. “Stem Cell Augmented Reconstruction: A New Hope for Reconstruction After Breast Conserving Therapy.” 30th Annual San Antonio Breast Cancer Symposium. Poster #4071.
  4. ^ Weiler-Mithoff, Eva, et al. “Cell-Enhanced Reconstruction after Breast Conservation Therapy: A Proven Technique.” 32nd Annual San Antonio Breast Cancer Symposium. Poster #4123.
  5. ^ Seaman, Marley. “Cytori Gets FDA Approval for PureGraft System.” Associated Press. 8 January 2010.

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