Infuse Bone Graft
Bone Grafting (Spine and Orthopaedic)
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Medtronic, Inc. (“Medtronic”) offers RemoteView, which permits a user (“Programmer User”) of the Medtronic CareLink® 2090 Programmer (“Programmer”) to allow the viewing of information presently displayed on the Programmer screen with one or more individuals in remote locations anywhere in the world (“Remote Viewer”), including remote health care professionals or Medtronic representatives.
Limited License Grant. You are hereby granted a nonexclusive, nontransferable, terminable, nonassignable, nonsublicensable, limited license to install and use a copy of the Licensed Software solely for authorized and legitimate purposes. You may not otherwise copy, use, modify, reverse engineer, decompile, disassemble, create derivative works based on, or integrate with other systems or programs the Licensed Software without the prior written consent of Medtronic. You shall have sole responsibility for any fees or charges, including service or data charges, incurred by you in connection with your use of the Licensed Software. You shall not remove any proprietary or other legend or restrictive notice contained or included in the Licensed Software or other documentation associated with such Licensed Software. You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation.
Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer.
“Active Remote Viewer” as referred to herein shall mean a Remote Viewer that has installed the Licensed Software and has at the relevant point in time an active network connection to a Medtronic server via the Licensed Software.
By installing or using the Licensed Software or clicking any acceptance button in connection with this Agreement, you acknowledge, understand, agree to, and consent to all of the following, including when you are an Active Remoter User:
) Registration. To obtain access to the Licensed Software, you must register at the Medtronic RemoteView website and establish a user name and password. All information that you provide in connection with such registration must be complete, accurate, and truthful. The user name and password are personal to you and must not be shared with anyone else. You will also not attempt, directly or indirectly, to disable, bypass, or defeat any password protection associated with the Licensed Software. Medtronic reserves the right to deny or disable any user name or password or request for any user name or password.
) Your Personal Information. Medtronic will collect information in connection with your registration and installation and use of the Licensed Software, including your first and last name, your email address, a selected security question(s) and your corresponding answer(s), your address, and your telephone number. You agree that Medtronic may store this personal information about you on a Medtronic server, including a server located in the United States of America.
) Session Key. To view the information on the Programmer, the Remote Viewer must generate a Session Key that must be shared with and entered by the Programmer User. “Session Key” as used herein means a unique token active for a limited period of time generated by the Remote Viewer. You agree not to share this Session Key with anyone other than the Programmer User who has initiated the specific session.
) Logging of Session Activity. Each time you log in to the Licensed Software, Medtronic will collect information about your activity, including in an aggregated log or database, regarding you and your session, including your name, username, computer name, IP address, operating system details, and session details (including transferring and sharing activity, start and end times, view only or control activity, and any chat messages between or among any Active Remote Viewers. You agree that Medtronic may store any personal information about you on a Medtronic server, including a server located in the United States of America.
) Active Remote Users. When you are an Active Remote Viewer: (1) you will be able to view the name and/or user name of any other Active Remote Viewer who is logged into the same Medtronic server; and (2) any other Active Remote Viewer who is actively logged into the same Medtronic server will be able to view your name and/or user name. The Licensed Software also permits one Active Remote Viewer to share the information being viewed to any other Active Remote Viewer. You must not share any information from the Medtronic programmer, including with any other Active Remote Viewer, absent the express permission from the Programmer User that is allowing you to view the information.
) Availability. Medtronic has limitations on the number of users that can concurrently log in to the Licensed Software at any given time. Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time.
Permissions. By installing and using the Licensed Software, you represent that you have permission to do so from any associated clinic, hospital, or medical practice and that your use of the Licensed Software complies with any policies or requirements of such associated clinic, hospital, or medical practice. You are also responsible for confirming that the Programmer User has obtained any necessary patient consent before allowing you to view any patient information via the Licensed Software.
Your Acknowledgements. You acknowledge that the Licensed Software is not the exclusive method of viewing information from the Programmer and that the Licensed Software is not the exclusive method by which to obtain a patient’s implanted cardiac device data, including any data on the Programmer. You also acknowledge that the Licensed Software is not intended to be used as a life-sustaining or interventional tool during medical emergencies. You further acknowledge that Medtronic is not, and shall not be deemed to be, a provider of patient health care services by virtue of its provision of access to the Programmer screen information via the Licensed Software. You also acknowledge that information from the Licensed Software is not an electronic medical record and use of the Licensed Software does not in any way relieve you from using your best medical judgment to determine a proper course of treatment for patients.
Security/Privacy of Patient Data. Your use of the Licensed Software and any Session Keys shall be solely for legitimate and lawful purposes and not for any malicious purpose. You are solely responsible for and will use your best efforts in maintaining the confidentiality and security of any copies of the Licensed Software as well as any user name, password credentials, and any Session Keys that can be used in accessing the Licensed Software, a Medtronic server, or any information from a Programmer. You are solely responsible for and will use your best efforts in keeping any patient information you may receive or view in connection with the Licensed Software confidential and secure, and you will not attempt to capture or copy any patient information you view in any electronic or hard copy format without the express permission of the Programmer User. You will be responsible for any obligations or liabilities associated with any lost, stolen, or otherwise compromised patient information.
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Limitations of Liability.
THE LICENSED SOFTWARE IS PROVIDED TO YOU “AS IS,” AND MEDTRONIC EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES WITH RESPECT TO THE LICENSED SOFTWARE AND YOUR USE THEREOF, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND NONINFRINGEMENT. MEDTRONIC DOES NOT WARRANT THAT THE USE OF THE LICENSED SOFTWARE WILL BE UNINTERRUPTED OR ERROR-FREE.
Legal Compliance. You shall at all times use the Licensed Software in compliance with all applicable laws. You shall ensure that your installation and use of the Licensed Software complies with all applicable export and import laws, regulations, orders, and policies of the United States of America and any other applicable jurisdiction. You represent and warrant that (i) you are not located in a country that is subject to a U.S. Government embargo, or that has been designated by the U.S. Government as a “terrorist supporting” country, and (ii) you are not listed on any U.S. Government list of prohibited or restricted parties.
Term, Termination, Modifications, and Support. This Agreement shall be in effect from the date when you first install or use the Licensed Software. Medtronic may modify, amend, or terminate this Agreement at any time, including by providing notices or an updated version of this Agreement on a Medtronic website. Medtronic may modify, disable, or terminate your use or Medtronic’s support of the Licensed Software at any time, including by providing notices on a Medtronic website. All obligations which are ongoing in nature shall survive termination or expiration of this Agreement. At any time upon Medtronic’s request (including via a notice on a Medtronic website), you agree to promptly delete and terminate use of any and all copies of the Licensed Software. In addition, upon Medtronic’s request, you agree to provide written verification that you have destroyed all copies of the Licensed Software together with the manner, date, and time of such destruction.
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Bone Grafting (Spine and Orthopaedic)
Infuse™ Bone Graft is the premium product for autograft replacement* due to its high osteoinductivity. Infuse bone graft is recombinant human bone morphogenetic protein-2 (rhBMP-2) applied to an absorbable collagen sponge carrier (ACS). One of the functions of the protein is to stimulate natural bone formation. Overall, bone morphogenetic protein technology has a lengthy history of extensive research and study dating back more than 50 years.
Bone morphogenetic proteins (BMPs) play a role in the formation of bone and cartilage, the healing of fractures, and the repair of other musculoskeletal tissues.2
The preferred method for obtaining BMP is to manufacture a recombinant version of a naturally occurring BMP using well-established molecular biology techniques. Recombinant human insulin (rhInsulin) is formulated using recombinant techniques as well. This production method results in a pure, single BMP. Recombinant production offers the advantage of tightly controlled manufacturing processes to ensure purity, consistency, and sterility.
The Mechanism of Action (MOA) includes six steps. Table 1 includes an overview of the steps, and each step is described in detail below.
|Table 1: Mechanism of Action for rhBMP-2/ACS*|
|1||Implantation||rhBMP-2/ACS is implanted.|
|2||Chemotaxis||Migration of mesenchymal stem cells and other bone-forming cells to the site of implantation.|
|3||Proliferation||rhBMP-2/ACS provides an environment where stem cells multiply prior to differentiation.|
|4||Differentiation||rhBMP-2 binds to specific receptors on the stem cell surface signaling them to differentiate into osteoblasts.|
|5||Bone formation and angiogenesis||Osteoblasts respond to local mechanical forces to produce new mineralized tissue replacing the ACS. New blood vessel formation is observed at the same time.|
|6||Remodeling||The body continues to remodel bone in response to the local environmental and mechanical forces, resulting in normal trabecular bone.|
When rhBMP-2 is placed on an ACS and implanted in the body, it produces new bone tissue at the site of implantation. Neither the rhBMP-2 nor the ACS can produce new bone tissue independently. Only when they're used together do they initiate the bone induction process.
Bone-forming cells migrate to the area of the rhBMP-2/ACS implant. This cell migration stimulated by a chemical response is called chemotaxis. Mesenchymal stem cells (MSC) move from bleeding bone, muscle, and the periosteum to infiltrate the implant.
The mesenchymal stem cells around the rhBMP-2/ACS implant increase in number. In-vitro studies have shown that rhBMP-2 can increase the proliferation of several multipotent cell lines, which can differentiate into osteoblasts, or bone-forming cells.3-7
Binding to specific receptors on the surface of the MSC, rhBMP-2 causes them to differentiate into bone-forming cells.2, 7 In-vitro studies of rhBMP-2 support the fact that differentiation of mesenchymal stem cells into bone-forming osteoblasts plays an essential role in the induction of new bone.1 Pre-clinical studies have shown that rhBMP-2 can cause the differentiation of precursor cells into osteoblasts.3-19
A 2003 in-vitro study compared the bone-forming activity of 14 recombinant human bone morphogenetic proteins.20 Three cell lines, representing the different stages of osteoblast differentiation, were each tested. Alkaline phosphatase activity — a measure of the amount of new bone formation — was significantly increased in all three cell lines by BMP-2, BMP-6, and BMP-9. The researchers concluded that BMP-2, BMP-6, and BMP-9 may be the most potent agents to induce osteoblast lineage-specific differentiation of mesenchymal stem cells.
As the sponge degrades or dissolves, these stem cells differentiate into osteoblast and begin to form trabecular bone and/or cartilage. Blood vessel formation (angiogenesis) is observed at the same time. The bone formation process develops from the outside of the rhBMP-2/ACS implant towards the center until the entire implant is replaced by trabecular bone.
Pre-clinical studies support that the bone formation started by rhBMP-2/ACS is self-limiting, forming a predictable amount of bone at the site of implantation. The ability of rhBMP-2 to induce new bone formation depends on its concentration. The rate of bone formation, the amount of bone formed, and the density of the resulting bone are positively correlated with both the concentration of rhBMP-2 and the length of time that rhBMP-2 is present at the implant site.1
Remodeling of the trabecular bone induced by rhBMP-2 is consistent with the biomechanical forces placed on it. Radiographic, biomechanical, and histologic evaluation of the induced bone indicates that it functions biologically and biomechanically as native bone. Preclinical studies also indicate that the induced bone can repair itself, if fractured, in a manner indistinguishable from native bone healing.1
The key element to Infuse bone graft is rhBMP-2 which is manufactured using well-established molecular biology techniques. This protein is a replication of bone morphogenetic protein-2 (BMP-2), which occurs naturally in humans and is important in healing and regenerating bone. This tightly controlled process of manufacturing rhBMP-2 ensures consistency and sterility of pure solutions of BMP. The process includes two phases.
PHASE 1: IDENTIFYING, REPLICATING, AND STORING THE HUMAN GENE FOR BMP-2
The process began by first identifying and isolating the specific gene that carries the code for making bone morphogenetic protein-2. Once it was isolated, it was spliced and then recombined into the DNA of a commonly used mammalian cell, called a production cell. Recombinant refers to the insertion, or recombination, of the gene into the production cell.
As these recombined cells grow and multiply, they include the new gene in their DNA. This replication process results in a homogeneous population of cells that can produce rhBMP-2.
A single batch of rhBMP-2 production cells is grown and distributed into several hundred small vials, called a cell bank. This bank is the source for all future production of rhBMP-2. To safely maintain the cells, the small vials are frozen at -135°C and stored in secure, monitored, temperature-controlled freezers. Because only a few recombined cells are needed to make many millions of rhBMP-2 units and future cell banks, the isolation and cloning process doesn't need to be repeated.
PHASE 2: PRODUCING, PURIFYING, AND STERILIZING rhBMP-2
To produce rhBMP-2, a vial of the production cells is placed into a glass spinner flask. This flask contains nutrients the cells need to grow and produce rhBMP-2. These nutrients, or 'medium,' contain a combination of vitamins, amino acids, minerals, and sugar, but they do not contain any human or animal components.
Next, the cells are transferred to a bioreactor, which is a computer-controlled, closed-system environment where large-scale production begins. After a growth period of about three days, the recombined cells are filtered away from the rhBMP-2 containing medium and discarded. The rhBMP-2 moves on to the purification process, which involves a series of four chromatography columns. Then it's sterilized with nano filtration as an added viral safety assurance, even though no human or animal components are added during the recombinant production process.
QUALITY VALIDATION OF rhBMP-2
Throughout the production process, quality control testing is done to assess the safety, consistency, and purity of all materials. This includes a large number of tests that are completed during the manufacture of rhBMP-2. Quality-checked liquid rhBMP-2 is filtered and freeze-dried in vials and then further tested for purity and consistency.
The Smartstorage™ System is an RFID-based, near real-time tissue tracking system that streamlines inventory management. No more worrying about manual recordkeeping — the Smartstorage System keeps accurate usage history and temperature logs. The system also notifies you when conditions need to be checked and assures precise accountability.
Find these technical manuals in the Medtronic Manual Library, in the product labeling supplied with each product, or by calling Medtronic at 800-961-9055.
BRIEF SUMMARY OF INDICATIONS, CONTRAINDICATIONS, AND WARNINGS FOR:
Infuse™ Bone Graft/LT-Cage™ Lumbar Tapered Fusion Device
Infuse™ Bone Graft/Inter Fix™ Threaded Fusion Device
Infuse™ Bone Graft/Inter Fix™ RP Threaded Fusion Device
Infuse™ Bone Graft/Perimeter™ Interbody Fusion Device
Infuse™ Bone Graft/Clydesdale™ Spinal System
Infuse™ Bone Graft/Divergence-L™ Anterior/Oblique Lumbar Fusion System
Infuse™ Bone Graft/Pivox™ Oblique Lateral Spinal System
The Infuse™ Bone Graft/Medtronic Interbody Fusion Device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1, who may also have up to Grade I spondylolisthesis or Grade 1 retrolisthesis at the involved level.
The following interbody devices and surgical approaches may be used with Infuse™ Bone Graft:
The Infuse™ Bone Graft/Medtronic Interbody Fusion Device consists of two components containing three parts – a spinal fusion cage, a recombinant human bone morphogenetic protein, and a carrier/scaffold for the bone morphogenetic protein and resulting bone. These components must be used as a system for the prescribed indication described above. The bone morphogenetic protein solution component must not be used without the carrier/scaffold component or with a carrier/scaffold component different from the one described in this document. The Infuse™ Bone Graft component must not be used without the Medtronic Interbody Fusion Device component.
NOTE: The Inter Fix™ Threaded Fusion Device and the Inter Fix™ RP Threaded Fusion Device may be used together to treat a spinal level. The LT-Cage™ Lumbar Tapered Fusion Device, the Perimeter™ Interbody Fusion Device, the Clydesdale™ Spinal System, the Divergence-L™ Anterior/Oblique Lumbar Fusion System, and the Pivox™ Oblique Lateral Spinal System implants are not to be used in conjunction with either the Inter Fix™ OR Inter Fix™ RP implants to treat a spinal level.
The Infuse™ Bone Graft/Medtronic Interbody Fusion Device is contraindicated for patients with a known hypersensitivity to recombinant human Bone Morphogenetic Protein-2, bovine Type I collagen, or to other components of the formulation and should not be used in the vicinity of a resected or extant tumor, in patients with any active malignancy, or patients undergoing treatment for a malignancy; in patients who are skeletally immature; in pregnant women; or in patients with an active infection at the operative site or with an allergy to titanium, titanium alloy, or polyetheretherketone (PEEK).
There are no adequate and well-controlled studies in human pregnant women. In an experimental rabbit study, rhBMP-2 has been shown to elicit antibodies that are capable of crossing the placenta. Women of child bearing potential should be warned by their surgeon of potential risk to a fetus and informed of other possible orthopedic treatments. The safety and effectiveness of this device has not been established in nursing mothers. Women of child- bearing potential should be advised to not become pregnant for one year following treatment with this device.
Please see the Infuse™ Bone Graft package insert for the complete list of indications, warnings, precautions, adverse events, clinical results, definition of DDD, and other important medical information. The package insert also matches the sizes of those sized devices that are indicated for use with the appropriate Infuse™ Bone Graft kit. An electronic version of the package insert may be found at www.medtronic.com/manuals.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician with appropriate training or experience.
BRIEF SUMMARY OF INDICATIONS, CONTRAINDICATIONS, AND WARNINGS FOR:
INFUSE™ BONE GRAFT
Infuse Bone Graft is indicated for treating acute, open tibial shaft fractures that have been stabilized with IM nail fixation after appropriate wound management. Infuse Bone Graft must be applied within 14 days after the initial fracture. Prospective patients should be skeletally mature.
Infuse Bone Graft consists of two components – recombinant human Bone Morphogenetic Protein-2 solution and a carrier/scaffold for the bone morphogenetic protein solution and resulting bone. These components must be used as a system. The bone morphogenetic protein solution component must not be used without the carrier/scaffold component or with a carrier/scaffold component different from the one described in this document.
Infuse Bone Graft is contraindicated for patients with a known hypersensitivity to recombinant human Bone Morphogenetic Protein-2, bovine Type I collagen or to other components of the formulation and should not be used in the vicinity of a resected or extant tumor, in patients with an active malignancy or patients undergoing treatment for a malignancy. Infuse Bone Graft should also not be used in patients who are skeletally immature, in patients with an inadequate neurovascular status, in patients with compartment syndrome of the affected limb, in pregnant women, or in patients with an active infection at the operative site.
There are no adequate and well controlled studies in human pregnant women. In an experimental rabbit study, rhBMP-2 has been shown to elicit antibodies that are capable of crossing the placenta. Women of child bearing potential should be warned by their surgeon of potential risk to a fetus and informed of other possible orthopedic treatments. The safety and effectiveness of this device has not been established in nursing mothers. Women of child-bearing potential should be advised to not become pregnant for one year following treatment with this device.
Please see the package insert for the complete list of indications, warnings, precautions, adverse events, clinical results, and other important medical information.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician with appropriate training or experience.
Approved for use in certain spinal, dental, and trauma indications.
The commonly accepted mechanism of action as determined by in-vitro and in-vivo studies.
U.S. Food and Drug Administration. Summary of Safety and Effectiveness Data for Infuse Bone Graft/LT-Cage™ Lumbar Tapered Fusion Device (PMA Number P000058). Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/p000058b.pdf. Accessed March 10, 2006.
Schmitt JM, Hwang K, Winn SR, Hollinger JO. Bone morphogenetic proteins: an update on basic biology and clinical relevance. J Orthop Res. 1999 Mar;17(2):269-278. Review.
Yamaguchi A, Katagiri T, Ikeda T, Wozney JM, Rosen V, Wang EA, Kahn AJ, Suda T, Yoshiki S. Recombinant human bone morphogenetic protein-2 stimulates osteoblastic maturation and inhibits myogenic differentiation in vitro. J Cell Biol. 1991 May;113(3):681-687.
Puleo DA. Dependence of mesenchymal cell responses on duration of exposure to bone morphogenetic protein-2 in vitro. J Cell Physiol. 1997 Oct;173(1):93-101.
Wilke A, Traub F, Kienapfel H, Griss P. Cell differentiation under the influence of rh-BMP-2. Biochem Biophys Res Commun. 2001 Jun 29;284(5):1093-1097.
Katagiri T, Yamaguchi A, Ikeda T, Yoshiki S, Wozney JM, Rosen V, Wang EA, Tanaka H, Omura S, Suda T. The non-osteogenic mouse pluripotent cell line, C3H10T1/2, is induced to differentiate into osteoblastic cells by recombinant human bone morphogenetic protein-2. Biochem Biophys Res Commun. 1990 Oct 15;172(1):295-299.
Bain G, Muller T, Wang X, Papkoff J. Activated beta-catenin induces osteoblast differentiation of C3H10T1/2 cells and participates in BMP2 mediated signal transduction. Biochem Biophys Res Commun. 2003 Jan 31;301(1):84-91.
Kawasaki K, Aihara M, Honmo J, Sakurai S, Fujimaki Y, Sakamoto K, Fujimaki E, Wozney JM, Yamaguchi A. Effects of recombinant human bone morphogenetic protein-2 on differentiation of cells isolated from human bone, muscle, and skin. Bone. 1998 Sep;23(3):223-231.
Gallea S, Lallemand F, Atfi A, Rawadi G, Ramez V, Spinella-Jaegle S, Kawai S, Faucheu C, Huet L, Baron R, Roman-Roman S. Activation of mitogen-activated protein kinase cascades is involved in regulation of bone morphogenetic protein-2-induced osteoblast differentiation in pluripotent C2C12 cells. Bone. 2001 May;28(5):491-498.
Hughes FJ, Collyer J, Stanfield M, Goodman SA. The effects of bone morphogenetic protein-2, -4, and -6 on differentiation of rat osteoblast cells in vitro. Endocrinology. 1995 Jun;136(6):2671-2677.
Boden SD, McCuaig K, Hair G, Racine M, Titus L, Wozney JM, Nanes MS. Differential effects and glucocorticoid potentiation of bone morphogenetic protein action during rat osteoblast differentiation in vitro. Endocrinology. 1996 Aug;137(8):3401-3407.
Thies RS, Bauduy M, Ashton BA, Kurtzberg L, Wozney JM, Rosen V. Recombinant human bone morphogenetic protein-2 induces osteoblastic differentiation in W-20-17 stromal cells. Endocrinology. 1992 Mar;130(3):1318-1324.
Yamaguchi A, Ishizuya T, Kintou N, Wada Y, Katagiri T, Wozney JM, Rosen V, Yoshiki S. Effects of BMP-2, BMP-4, and BMP-6 on osteoblastic differentiation of bone marrow-derived stromal cell lines, ST2 and MC3T3-G2/PA6. Biochem Biophys Res Commun. 1996 Mar 18;220(2):366-371.
Ikeuchi M, Dohi Y, Horiuchi K, Ohgushi H, Noshi T, Yoshikawa T, Yamamoto K, Sugimura M. Recombinant human bone morphogenetic protein-2 promotes osteogenesis within a telopeptide type I collagen solution by combination with rat cultured marrow cells. J Biomed Mater Res. 2002 Apr;60(1):61-69.
van den Dolder J, de Ruijter AJ, Spauwen PH, Jansen JA. Observations on the effect of BMP-2 on rat bone marrow cells cultured on titanium substrates of different roughness. Biomaterials. 2003 May;24(11):1853-1860.
Arpornmaeklong P, Kochel M, Depprich R, Kubler NR, Wurzler KK. Influence of platelet-rich plasma (PRP) on osteogenic differentiation of rat bone marrow stromal cells. An in vitro study. Int J Oral Maxillofac Surg. 2004 Jan;33(1):60-70.
Fromigue O, Marie PJ, Lomri A. Bone morphogenetic protein-2 and transforming growth factor-beta2 interact to modulate human bone marrow stromal cell proliferation and differentiation. J Cell Biochem. 1998 Mar 15;68(4):411-426.
Kim KJ, Itoh T, Kotake S. Effects of recombinant human bone morphogenetic protein-2 on human bone marrow cells cultured with various biomaterials. J Biomed Mater Res. 1997 Jun 5;35(3):279-285.
Lecanda F, Avioli LV, Cheng SL. Regulation of bone matrix protein expression and induction of differentiation of human osteoblasts and human bone marrow stromal cells by bone morphogenetic protein-2. J Cell Biochem. 1997 Dec 1;67(3):386-396.
Cheng H, et al, Osteogenic Activity of the Fourteen Types of Human Bone Morphogenetic Proteins (BMPs). Journal of Bone and Joint Surgery, 2003, 1544-1552.
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