SAN DIEGO, Nov. 20, 2017 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (CYTX) announced today the publication of preclinical data from a study using Cytori Cell Therapy™ in a model of fibrotic scar formation. This study was performed with support from the Biomedical Advanced Research and Development Authority (BARDA) as a component of the preclinical proof of concept data package incorporated into the FDA approved United States RELIEF Trial.
The publication describes a study in which Adipose Derived Regenerative Cells (ADRCs), the active component of Cytori Cell Therapy™, were injected into deep partial thickness wounds in a porcine model, considered the gold standard preclinical model of hypertrophic scarring. Six months after treatment, wounds that were treated with ADRCs showed reduction in parameters associated with hypertrophic scarring compared to control wounds. Parameters that were improved by treatment included skin hardness, organization, vascularity, and discoloration. Molecular analysis implicated the temporal modulation of Interleukin-6 expression, a key regulator of the inflammatory response, as a potential mediator of the effect.
The paper entitled “Autologous adipose-derived regenerative cell therapy modulates development of hypertrophic scarring in a red Duroc porcine model ” just published in the journal Stem Cell Research and Therapy and is now available online.
The findings from this preclinical study were incorporated into the design of the RELIEF clinical trial of Cytori Cell Therapy™ which is also funded by BARDA. The RELIEF trial will assess Cytori Cell Therapy in human patients with substantial thermal burn injury. In addition to assessment of early healing, the RELIEF trial will evaluate several scar-related parameters using approaches similar to those applied in this study.
“Fibrosis is a common factor in both burns and scleroderma.” said Dr. John Fraser, Chief Scientist at Cytori. “This preclinical study is consistent with a number of emerging studies indicating a beneficial effect of Cytori’s ADRC technology in fibrotic disease.”
The treatment of thermal burns remains a critical unmet medical need. Despite standard of care primarily consisting of dressings, skin grafts and skin substitutes, patients frequently suffer from pain, scarring, skin contracture and reduced range of motion. Hypertrophic scarring is characterized by raised, discolored, itchy and painful scars that are a common fibrotic consequence of deep-partial thickness burn injury.
Autologous cell therapies such as those offered by Cytori have the potential to improve the quality and rate of wound healing and reduce scarring. In a mass casualty event, the Government Accountability Office estimates that as many as 10,000 patients could require thermal burn care. The limited number of specialist surgeons and burn centers in the U.S. creates a public health need for a burn wound therapy that can be quickly and broadly applied by non-specialist medical personnel following such an event. Therefore, autologous Cytori’s Cell Therapy represents a novel medical countermeasure not only to address these challenges but also to promote wound healing and tissue repair and improve casualty care.
The RELIEF trial will assess safety and feasibility of intravenous delivery of Cytori Cell Therapy™ as an adjunct to usual care in patients with thermal burn injuries covering between 20% and 50% of their body surface area. Subjects will have at least one deep partial or full thickness burn wound that is to be treated with a meshed autologous split thickness skin graft (STSG). Subjects will be randomized (1:2) to receive either usual care alone or usual care supplemented with Cytori Cell Therapy. While primarily focusing on safety and feasibility, the RELIEF trial will also assess a series of parameters related to skin graft healing. The trial is approved to enroll up to 30 patients in up to 10 U.S. sites with study initiation expected to occur soon.
Cytori is a therapeutics company developing regenerative and oncologic therapies from its proprietary cell therapy and nanoparticle platforms for a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy™ acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori’s proprietary technologies and products. Cytori Nanomedicine™ is developing encapsulated therapies for regenerative medicine and oncologic indications using technology that allows Cytori to use the benefits of its encapsulation platform to develop novel therapeutic strategies and reformulate other drugs to optimize their clinical properties. For more information, visit www.cytori.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, without limitation, statements regarding the potential for autologous cell therapies such as those offered by Cytori to improve the quality and rate of wound healing and reduce scarring and Cytori Cell Therapy’s potential to provide benefits across multiple disease states, are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. These risks and uncertainties, which include inherent uncertainties in conduct of clinical studies and trials and the results of such trials (including risks that further studies may not support efficacy or safety of Cytori Cell Therapy), risks associated with clinical use of Cytori Cell Therapy in studies and trials not controlled by Cytori and risks to Cytori’s intellectual property portfolio are described under the heading "Risk Factors" in Cytori's Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. Cytori assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.