Cytori Therapeutics
Cytori Therapeutics, Inc., of the United States, is a regenerative-medicine company, based in San Diego. 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
Cytori Therapeutics, Inc. is a late stage cell therapy company developing autologous cell therapies from adipose tissue to treat a variety of medical conditions. The company was created as the result of a 2002 merger between Macropore Biosurgery Inc. (founded in 1996) and StemSource Inc. (founded in 2000). The joint company operated under the Macropore name until 2005 when it changed its name to Cytori Therapeutics. Cytori is headquartered in San Diego, CA, and also has operations in Japan and the United Kingdom.
Core technology: the Celution System
Cytori develops cellular therapeutics formulated for specific diseases and medical conditions. Clinical development programs are currently targeting impaired hand function in scleroderma (Phase III clinical), osteoarthritis of the knee (Phase II clinical), and thermal burn injury (preclinical phase).
Cytori’s cellular therapeutics are collectively known as Cytori Cell TherapyTM, and consist of different formulations of a heterogeneous population of cells (including stem cells) that are involved in response to injury, repair and healing. This cell therapy product is prepared from a patient’s own adipose (fat) tissue using the company’s fully automated Celution® System that disaggregates adipose tissue and liberates the entrapped stem and regenerative cells that naturally reside in native adipose. The system formulates a cell therapy product that is available for delivery to the patient within 1-2 hours of tissue collection.
Cytori’s lead indication is currently in a US phase III, FDA approved , pivotal study, the STAR TRIAL (ClinicalTrials.gov Identifier: NCT02396238), designed to evaluate Cytori’s ECCS-50 in treating impaired hand function from scleroderma. The company has also enrolled a US, FDA approved, Phase II study, ACT-OA TRIAL (ClinicalTrials.gov Identifier: NCT02326961), to examine ECCO-50 as an effective treatment for osteoarthritis of the knee, with data expected to be released in Q1 2016.
Cosmetic and reconstructive surgery
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
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.[1]
RESTORE 2
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 physicians were satisfied with the outcome of the procedure.[2]
Fat grafting
In addition to Celution, Cytori 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.[3] In addition to the Puregraft System, Cytori has developed the Celbrush, a precision fat graft delivery tool.
Cardiovascular disease
Cytori is sponsoring two European safety and feasibility studies for the treatment of cardiovascular disease using ADRCs extracted using the Celution System.
APOLLO
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 met after the enrollment of 14 patients. Primary outcomes for the study will be assessed at the six month follow up. The ADRC therapy resulted in a reduction in infarct size by 60%, and significant improvement of LV perfusion (MIBI SPECT) and an improvement of left ventricular function by 6% at 6 month followup. At 36 months FU, the improvement on infarct size persisted, as well as the effect LV function. An progressive improvement of cardiac remodelling was noted.
PRECISE
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
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
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
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
- ↑ 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.
- ↑ Weiler-Mithoff, Eva, et al., “Cell-Enhanced Reconstruction after Breast Conservation Therapy: A Proven Technique”. 32nd Annual San Antonio Breast Cancer Symposium. Poster #4123.
- ↑ Seaman, Marley (8 January 2010) “Cytori Gets FDA Approval for Puregraft System”, Associated Press.