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Cytori Reports Publication of Interim Pilot Data for Cell Therapy in Vocal Fold Scarring
SAN DIEGO, Aug. 09, 2018 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (NASDAQ:CYTX) announced publication in the peer-reviewed journal, Stem Cell Research and Therapy, of “Autologous adipose-derived stromal vascular fraction and scarred vocal folds: first clinical case report.” This report describes preliminary data from the CELLCORDES trial of Cytori Cell Therapy™ (ADRCs) in patients with severe voice dysfunction due to scarring of the vocal fold (vocal cords).
The CELLCORDES trial is a fully-enrolled investigator-initiated pilot trial conducted using Cytori Cell Therapy. The trial is being performed by Investigators at the Department of Oto-Rhino-Laryngology and Head and Neck Surgery of Aix-Marseille University and the Cell Therapy Laboratory of La Conception University Hospital, both of Marseille, France. Additional details on the trial may be found at clinicaltrials.gov.
The reported index patient had severe vocal dysfunction persisting for four years following traditional surgery to treat chronic vocal fold lesions. Twelve months after single direct administration with 12 million ADRCs, the patient exhibited improvements in Vocal Handicap Index and other qualitative and quantitative measures of voice quality including: Hirano’s GRB scale (measuring vocal hoarseness, roughness, and breathiness), Jitter (a measure of uncontrolled variation in frequency of the voice), and vocal range. The authors noted that while the remaining seven patients treated in the CELLCORDES study have yet to complete 12-months of follow-up, no serious adverse events have been reported in any subject and no subject has reported worsening of vocal function. Furthermore, three are exhibiting “very good results (especially on the VHI)”.
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 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, 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.