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New findings on PUR Biologic's human extracellular matrix material in cartilage formation published in the journal Stem Cell Reviews and Reports.
PUR Biologics, LLC, a biotech company focused on biologics and devices for musculoskeletal conditions, today announced the publication of new findings on its human extracellular matrix material for stem cell proliferation and cartilage formation in the peer-reviewed journal Stem Cell Reviews and Reports.
Work led by Dr. Wan-Ju Li in the Department of Orthopedics and Rehabilitation and the University of Wisconsin-Madison for the first time demonstrated the ability of a naturally-secreted human extracellular matrix (hECM) to not only support the proliferation of mesenchymal stem cells (MSCs), but to also upregulate the genes associated with hyaline cartilage formation. Further, this work showed that MSCs treated with hECM had increased chondrogenic potential, or increased potential to form cartilage, than untreated MSCs.
MSC subpopulations composed of cells with specific cell surface markers, CD73+,CD90+,CD105+, and CD45−, are known to have a greater therapeutic capacity than the MSC population as a whole. Importantly, this latest research has shown that by culturing MSCs with hECM the number of cells with these markers increases exponentially.
“The main limitation of MSC therapies is the inability to grow a sufficient number of cells without changing their characteristics,” said Dr. Li. “We have found that hECM both increases the proliferate of these cells and primes them to become chondrocytes, which has the potential to be hugely impactful in the treatment of various cartilage disorders.”
In addition, MSCs treated with hECM were shown to produce more collagen type 2, the primary collagen in articular cartilage, and collagen type 10, the primary collagen in the calcified cartilage layer. At the same time, treatment with hECM reduced the production of collagen type 1 which is distributed in fibrocartilage. This suggests that hECM may be well suited in the induction of hyaline cartilage formation.
The results of this research support previous studies in full thickness osteochondral defects in rat, rabbit and goat models, where mature hyaline cartilage was formed after implantation of hECM.
Manufactured by PUR’s joint venture partner Histogen, Inc., the extracellular matrix utilized in this research is produced through a proprietary novel technology process which triggers the de-differentiation of fibroblast cells into multipotent stem cells through low oxygen and special culture conditions. This results in a hECM that is embryonic-like without utilizing embryonic stem cells, and that has potential benefit in a number of orthopedic applications.
"PUR is closer than ever to putting together the pieces of quality cartilage repair in the human body,” said Ryan Fernan, CEO at PUR Biologics. "Dr. Li's work demonstrates how PUR's materials maintain the perfect environment for your body's own cells to naturally and effectively heal itself, potentially providing a vitally needed solution to the millions suffering from cartilage complications."
The paper entitled “Effects of Human Fibroblast-Derived Extracellular Matrix on Mesenchymal Stem Cells” is currently published in the online edition of Stem Cell Reviews and Reports, available HERE.
About PUR Biologics
PUR Biologics is dedicated to providing regenerative biologic and device solutions to address musculoskeletal surgical needs, including orthopedic, spine, dental, and medical device coating applications. In addition to distribution of approved allograft and biologic products, PUR is focused on development of next-generation orthopedic products based upon human protein and growth factor materials for bone and tissue regeneration. For more information visit http://www.purbiologics.com.
To view the article on PRWEB.com go HERE.
PUR Biologics, LLC, a joint venture focused on the emerging field of biologics for musculoskeletal conditions, including spine, dental and medical device applications, announced initial data today on its human extracellular matrix for cartilage repair. Dr. Daniel Grande, Director of the Orthopaedic Research Laboratory at The Feinstein Institute for Medical Research will present his findings at the 2014 Orthopaedic Research Society Annual Meeting in New Orleans, LA.
PUR’s material is derived through a proprietary technology process that simulates the conditions of the embryonic environment, including very low oxygen. The human extracellular matrix (hECM) produced through this process has a distinctive composition of proteins including decorin, SPARC, collagens, fibronectin, fibrillin, and laminins, which are known to stimulate stem cells in the body, regenerate tissues, and promote scarless healing.
“We are honored to be working with Dr. Grande, a renowned cartilage researcher,” said Ryan Fernan, CEO of PUR Biologics. “Dr. Grande’s work with our hECM to date is very encouraging, and we are plotting the path into the clinic for chondral defect repair, for which over 200,000 surgeries take place each year in the United States alone.”
In vitro and in vivo studies performed by Dr. Grande’s group examined whether the augmentation of osteochondral (full thickness cartilage/bone) defects with hECM can improve the quality of the resulting tissue repair. In this study, chondrocytes and mesenchymal stem cells grown in hECM-supplemented media showed increases in aggregan gene expression and inhibition of type I collagen gene expression, suggesting that this biomaterial would stimulate normal hyaline cartilage restoration in vivo.
Further evaluation of the hECM as a filler in trochlear groove defects in male Sprague-Dawley rats showed a significant macroscopic healing improvement when compared to empty defect controls. These results support the use of the unique, growth factor-rich, hECM material as an improved environment for MSC’s and chondrocytes to initiate cartilage repair.
“Inducing normal hyaline cartilage regeneration has been difficult to date,” said Dr. Grande. “The hECM utilized in our osteochondral defect studies resulted in rapid remodeling of bone and hyaline cartilage with a statistically significant difference (p<0.001) in the O’Driscoll score seen as early as six weeks.”
Dr. Grande will present “Testing of a Novel Biomaterial for Regenerative Orthopaedic Applications” at the Orthopaedic Research Society Annual Meeting, taking place March 15-18, 2014 in New Orleans.
PUR Biologics, LLC, a joint venture focused on the emerging field of biologics for musculoskeletal conditions, including spine, dental and medical device applications, today announced that the United States Patent & Trademark Office has issued two patents covering the multipotent stem cell-derived material utilized by PUR, and its applications in the repair and regeneration of tissue.
The US Patent & Trademark Office issued patent 8,524,494, entitled “Low Oxygen Tension and bFGF Generates a Multipotent Stem Cell from a Fibroblast In Vitro”, and patent 8,530,415, entitled “Repair and/or Regeneration of Cells with a Composition Produced by Culturing Fibroblast Cells under Hypoxic Conditions”, to PUR’s joint venture partner Histogen, Inc. on September 3 and September 9, 2013, respectively.
The issued patents cover Histogen’s novel technology which triggers the de-differentiation of fibroblast cells into multipotent stem cells through low oxygen and special culture conditions, as well as methods of inducing tissue repair and regeneration by contacting cells with the naturally-secreted multipotent cell conditioned media (CCM) and extracellular matrix (ECM) materials.
“These novel multipotent cell-derived materials hold tremendous potential in orthopedic applications, where we seek to regenerate musculoskeletal tissues and support stem cell growth,” said Ryan Fernan, CEO of PUR Biologics. “Particularly exciting to us is the ability of the material to induce angiogenesis, which is not addressed with currently available orthopedic products.”
Unlike other stem cell-derived therapies, Histogen’s process uniquely begins with newborn fibroblasts cells, a safe, well-established and non-controversial cell source, and converts the cells into multipotent stem cells without genetic manipulation. PUR Biologics is currently researching and developing products based upon the CCM and ECM materials produced by these multipotent cells, which have potential benefit in a number of orthopedic applications such as bone and cartilage regeneration.
“While there is a lot of excitement and promise around stem cell-derived treatments in orthopedics, therapies utilizing embryonic stem cells or genetically-manipulated induced pluripotent stem cells carry inherent ethical and potential safety concerns for patients,” said Dr. Burak Ozgur, Chief of Neurosurgery Spine Service at Hoag Hospital. “Products that could capture the benefits of stem cell treatments without these concerns, such as the multipotent cell materials being developed by PUR, hold tremendous potential as the future of orthopedics.”
Histogen Inc., a regenerative medicine company developing solutions based on the products of cells grown under simulated embryonic conditions, has partnered with a Southern California medical device executive management and investment group to establish PUR Biologics, LLC. PUR is a joint venture focused on the emerging field of biologics for musculoskeletal conditions, including spine, dental and medical device applications.
Under this joint venture, PUR Biologics has acquired exclusive worldwide rights to Histogen's human multipotent cell conditioned media (CCM) and extracellular matrix (ECM) materials for use in the orthopedic areas of bone, cartilage, spinal disc and ligament regeneration, as well as device coatings. A soluble composition of naturally-secreted proteins, the CCM contains growth factors such as follistatin and stem cell factor which are known to stimulate stem cell growth, differentiation, and tissue regeneration. The insoluble ECM, made up of a variety of collagens and other matrix proteins, holds promise as an excellent biologically-active filler, attracting fibroblasts and stem cells as well as supporting new tissue growth.
"Regenerative technologies are paramount in advancing the current state or orthopedics and neurosurgery," said Dr. Chad Prusmack Chief of Neurosurgery at Rocky Mountain Spine Clinic and consultant to the Denver Broncos. "The use of naturally-secreted human growth factors and matrix proteins, known to stimulate and support stem cell growth in the body, can prove to be transformational in the regeneration of multiple musculoskeletal and neuronal tissues. These unique preparations may be the universal 'transducer' needed for optimizing directed stem cell differentiation and healthy proliferation."
PUR Biologics will build upon early proof-of-concept data to bring orthopedic products based on the CCM and ECM through all stages of development and commercialization. The Company's first research and development efforts will be in the area of bone regeneration, which has potential benefit in a number of orthopedic applications.
The joint venture will be managed and funded by Histogen's partner group, made up of experts from the surgery and medical device industries. Ryan Fernan, CEO of the newly-created PUR Biologics, has spent more than a decade in medical sales and management, including bringing OC Surgical from a fledgling medical device distributorship to a multi-million dollar orthopedic business during his time as President of the Company. PUR Biologics' management and investment group has a proven track record synergistically packaging technologies and advancements in surgery to serve unmet medical needs.
"We are extremely excited to have access to Histogen's groundbreaking scientific platform," said Ryan Fernan. "Coupled with our extensive experience in product development, sales, and distribution, this will be a powerful relationship that will fuel development of much needed innovation in this space."
The creation of PUR Biologics allows Histogen to support the research required to bring its biologic products toward commercialization in the rapidly growing multi-billion dollar orthopedic market, while continuing to dedicate resources to the company's other promising aesthetic and therapeutic programs.
"Histogen's preliminary studies have shown that our human CCM and ECM materials support stem cell growth and differentiation into bone and other structural tissues, making orthopedics a promising and exciting area of research for our products," said Dr. Gail K. Naughton, Histogen CEO and Chairman of the Board. "This joint venture provides Histogen the opportunity to see its innovative cell-derived products make strides in the large and important orthopedic market, while continuing to focus on development of its hair growth, skincare and oncology applications."
About PUR Biologics
PUR Biologics is dedicated to providing regenerative biologic solutions to address musculoskeletal surgical needs, including spine, dental, ligament and medical device coating applications. In addition to distribution of approved allograft and biologic products, PUR is focused on development of next-generation orthopedic products based upon human protein and growth factor materials for bone and tissue regeneration. For more information visit www.purbiologics.com.
Histogen is a regenerative medicine company developing solutions based upon the products of cells grown under proprietary conditions that mimic the embryonic environment, including low oxygen and suspension. Through this unique technology process, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen's technology focuses on stimulating a patient's own stem cells by delivering a proprietary complex of multipotent human proteins that have been shown to support stem cell growth and differentiation. For more information, please visit http://www.histogen.com.
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