SAN DIEGO--(BUSINESS WIRE)--Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today the publication of the results from an investigator-initiated Phase I trial using Cytori Cell Therapy in patients with insufficient maxillary bone prior to dental implantation. The publication reported approximately 42% greater bone formation in maxillary sinus floor elevation (MSFE) procedures treated with cells in combination with scaffolds versus those that received scaffold alone.
“Bone Regeneration Using the Freshly Isolated Autologous Stromal Vascular Fraction of Adipose Tissue in Combination With Calcium Phosphate Ceramics”
The study, conducted by investigators from Departments of Orthopedic Surgery, Oral and Maxillofacial Surgery, and Oral Cell Biology of the VU University in Amsterdam, The Netherlands, enrolled 10 patients requiring dental implants but who had insufficient bone into which the implant could be inserted. The maxillary bone deficiency was treated with two different commonly-used, off-the-shelf bone calcium phosphate scaffolds that were used either alone or pre-loaded with Adipose-Derived Regenerative Cells (ADRCs) prepared using Cytori’s Celution™ System. In six patients, the patient served as their own control as one side of the mouth was treated with scaffold alone and the other side was treated with ADRC-supplemented grafts. Six months after treatment all patients underwent dental implant placement at which time a biopsy of the regenerated bone at the graft site was performed.
The trial results reported approximately 42% greater bone formation in grafts that were supplemented with ADRCs. Specifically, in patients who received both a control scaffold and a contralateral ADRC- supplemented scaffold, the ratio of bone volume to total graft volume as measured by micro computerized tomography (microCT) was 19.5% ± 3.8% in grafts supplemented with ADRCs versus 13.7% ± 4.4% for the control grafts (p = 0.03). A similar trend was seen by histologic assessment of biopsies. They also noted that all 10 patients were treated uneventfully, with no adverse effects reported or detected in a large set of safety parameters through =3 years of follow-up.
Regarding the findings, the authors stated: “A striking observation from the histomorphometric and micro-CT analyses was the active bone formation observed at the cranial side of the biopsies in 7 out of 10 of the selected bone biopsies taken from the study [ADRC-treated] side, but only in 1 case from the control side. To our knowledge, this phenomenon has never been described before and may be unique to the current set-up.”
The American Academy of Implant Dentistry reports that approximately 500,000 patients receive dental implant surgeries in the USA every year. A recent report estimated that the global market for dental implants is projected to reach $5.8 billion by 2022. Use of calcium phosphate scaffolds for bone repair and reconstruction is also common in orthopaedic surgery.
The paper is titled: “Bone Regeneration Using the Freshly Isolated Autologous Stromal Vascular Fraction of Adipose Tissue in Combination With Calcium Phosphate Ceramics” published in the journal Stem Cells Translational Medicine. A link to the abstract can be found here. A full copy can be obtained without charge by registering with the publisher.
About Cytori
Cytori Therapeutics is a late stage cell therapy company developing autologous cell therapies from adipose tissue to treat 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. 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 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 preclinical and clinical trials and the results of such trials (including risks that further studies may not support efficacy or safety of Cytori Cell Therapy) are described under the heading “Risk Factors” in Cytori’s Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.
Cytori Therapeutics, Inc.
Tiago Girao
+1.858.458.0900
ir@cytori.com
