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(12) United States Patent (10) Patent No.: US 9,034,315 B2 Geistlich (45) Date of Patent: May 19, 2015

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(12) United States Patent (10) Patent No.: US 9,034,315 B2 Geistlich (45) Date of Patent: May 19, 2015 USOO9034315B2 (12) United States Patent (10) Patent No.: US 9,034,315 B2 Geistlich (45) Date of Patent: May 19, 2015 (54) CELL-CHARGED MULTI-LAYER (2013.01); A61L 15/40 (2013.01); A61L 27/24 COLLAGEN MEMBRANE (2013.01); A61L 27/3804 (2013.01); A61L 27/3847 (2013.01); A61L 31/005 (2013.01); (75) Inventor: Peter Geistlich, Stansstad (CH) A61L 31/044 (2013.01); C12N 2533/54 (2013.01) (73) Assignee: ED. GEISTLICH SOEHNE AG FUER (58) Field of Classification Search CHEMISCHE INDUSTRIE, Wolhusen None (CH) See application file for complete search history. (*) Notice: Subject to any disclaimer, the term of this (56) References Cited patent is extended or adjusted under 35 U.S.C. 154(b) by 1099 days. U.S. PATENT DOCUMENTS 4,394,370 A 7/1983 Jefferies (21) Appl. No.: 11/509,826 4,516,276 A 5, 1985 Mittelmeier et al. (22) Filed: Aug. 25, 2006 (Continued) (65) Prior Publication Data FOREIGN PATENT DOCUMENTS US 2007/OO31388A1 Feb. 8, 2007 AU 660045 6, 1995 AU 663150 9, 1995 Related U.S. Application Data (Continued) (63) Continuation-in-part of application No. 1 1/317.247, OTHER PUBLICATIONS filed on Dec. 27, 2005, which is a continuation-in-part of application No. 10/367,979, filed on Feb. 19, 2003, Mason, J.M. et al., Viral vector laboratory, NSUH. Manhasset, NY. now abandoned, which is a continuation-in-part of (CORR, Nov. 2000), 7 pages. (Continued) (Continued) (30) Foreign Application Priority Data Primary Examiner — Allison Fox (74) Attorney, Agent, or Firm — Rothwell, Figg, Ernst & Oct. 10, 1997 (GB) ................................... 972 1585.9 Manbeck, P.C. (51) Int. Cl. (57) ABSTRACT A6IL 27/24 (2006.01) A multi-layer sheet of collagen membrane material includes CI2N 5/077 (2010.01) a barrier layer including an outer Smooth barrier face and A6L27/38 (2006.01) further including a fibrous face opposite the smooth barrier A6IL 5/32 (2006.01) face, and a matrix layer of collagen material adhered to the A6IL 15/40 (2006.01) fibrous face, the matrix layer including collagen I, collagen A6IL 3L/00 (2006.01) III, or a combination thereof, the matrix layer carrying culti (Continued) vated bone-forming cells including osteocytes, osteoblasts, stromal cells and/or stem cells committed to differentiation (52) U.S. Cl. into bone-forming osteoblasts. CPC ........... CI2N5/0654 (2013.01); A61L 27/3821 (2013.01); A61 K35/12 (2013.01); A61 L 15/325 6 Claims, 1 Drawing Sheet O l US 9,034,315 B2 Page 2 Related U.S. Application Data WO WO90, 13302 A1 11, 1990 WO WO92, 13565 A1 8, 1992 application No. 11/046,897, filed on Feb. 1, 2005, now WO WO93/10722 A2 6, 1993 abandoned, which is a continuation-in-part of applica- W W 2. f A. g 2. tion No. 10/213,437, filed on Aug. 7, 2002, OW aban- WO 94.21556 A1 9, 1994 doned, said application No. 11/046,897 is a continu- WO WO95/18638 A1 7, 1995 ation-in-part of application No. 09/925,728, filed on WO WO 96,24310 A1 8/1996 Aug. 10, 2001, now Pat. No. 7,141,072, and a continu- W. W. 93.3 k A. 88: ation-in-part of application No. 09/545,465, filed on WO WO98,02976 A1 1, 1998 Apr. 7, 2000, now Pat. No. 6,752,834, said application WO WO 98.08469 A2 3, 1998 No. 11/046,897 is a continuation-in-part of application W. W. 2. g A. 3. 2. No. 10869,909, filed on Jun. 18, 2004, now aban- WO WOO1,087.14 A1 2, 2001 doned, which is a continuation of application No. WO WOO1/15711 A1 3f2001 09/545.465, filed on Apr. 7, 2000, now Pat. No. 6,752, WO WOO1 (24842 A2 4, 2001 834, which is a continuation-in-part of application No. WO WOO1,91816 A1 12/2001 PCT/GB98/02976, filed on Oct. 5, 1998. OTHER PUBLICATIONS (60) Provisional application No. 60/357,839, filed on Feb. 21, 2002, provisional application No. 60/311,078, H.A. Breinan et al., “Reparative Tissues in Articular Cartilage filed on Aug. 10, 2001, provisional application No. Defects in a Canne Model Treated by Microfracture', 45th Annual 60/224,010, filed on Aug. 10, 2000. Meeting, Orthopaedic Research Society, Feb. 1-4, 1999, Anaheim, CA. (one page). (51) Int. Cl. C.R. Lee et al., “Harvest and Selected Cartilage Repair Procedures A6IL 3L/04 (2006.01) Affect Mechanical and Biochemical Properties of Uninvolved A61 K35/12 (2006.01) Articular Cartilage in the Canine Knee”, 45th Annual Meeting, Orthopaedic Research Society, Feb. 1-4, 1999, Anaheim, CA. (one (56) References Cited page). C.R. Lee et al., “The Contractile Behavior of Articular Chondrocytes U.S. PATENT DOCUMENTS in Collagen Matrices. In Vitro'. Tissue Engineering Soc., Dec. 4-6, 1998, Orlando, Fla. (one page). 4,880,429 A 11, 1989 Stone S.M. Mueller et al., “Alpha-Smooth Muscle Actin in Bovine Menis 4,975,527 A 12, 1990 Koezuka et al. cus Cells Seeded in Type I and Type II Collagen-GAG Matrices'. 5,162,430 A 11/1992 Rhee et al. 44th Annual Meeting, Orthopaedic Research Society, Mar. 16-19. 5,167,961 A 12/1992 Lussi et al. 5,197,985 A 3/1993 Caplanet al. 1998, New Orleans, Louisiana. (one page). 5,206,023 A 4, 1993 Hunziker S. Nehrer et al., “Chondrocyte-Seeded Type I and Type II Collagen 5,254,133 A 10, 1993 Seid Implants Investigated InVitro”, Fifth World Biomaterials Congress, 5,413,597 A 5/1995 Krajicek May 29-Jun. 2, 1996, Toronto, CA. (one page). 5,417,975 A 5, 1995 Lussi et al. S. Nehrer et al., “Autologous Chondrocyte-Seeded Type I and II 5,523,348 A 6, 1996 Rhee et al. Collagen Matrices Implanted in a Chondral Defect in a Canine 5,541,295 A 7, 1996 Barrach et al. Model”, 44th Annual Meeting, Orthopaedic Research Society, Mar. 5,567,806 A 10, 1996 Abdul-Malak et al. 5,573,771 A 11/1996 Geistlich et al. 16-19, 1998, New Orleans, Louisiana. (one page). 5,624,463 A 4/1997 Stone et al. S. Nehrer et al., “Chondrocyte-Seeded Type I and Type II Collagen 5,759,190 A 6, 1998 Vibe-Hansen et al. Matrices Implanted in a Chondral Defect in a Canine Model”, 7th 5,763,416 A 6, 1998 Bonadio et al. Conference European Orthopaedic Research Society, Barcelona, 5,837.278 A * 1 1/1998 Geistlich et al. .............. 424/444 1997. (one page). 5,989,269 A 11/1999 Vibe-Hansen et al. S. Nehreret al., “Characteristics of Articular Chondrocytes Seeded in 6,120,514 A 9, 2000 Vibe-Hansen et al. Collagen Matrices. In Vitro'. Tissue Engineering, 1998, pp. 175-183. 6,153,292 A 11/2000 Bell et al. 6,165,785 A * 12/2000 Ogle et al. .................... 435,347 vol. 4(2). 6,221, 109 B1 * 4/2001 Geistlich et al. ........... 623, 17.11 S. Nehrer et al., “Matrix Collagen Type and Pore Size Influence 6,283,980 B1 9, 2001 Vibe-Hansen et al. Behaviour of Seeded Canine Chondrocytes'. Biomaterials 18, (1997), pp. 769-776. 6,352,558 B1* 3/2002 Spector ...................... 623, 18.11 6,576,015 B2* 6/2003 Geistlich et al. 623, 16.11 Donna Schulz-Torres et al., “Tendon Cell Contraction of Collagen 6,713,085 B2 * 3/2004 Geistlich et al. ... ... 424/443 GAG Matrices. In Vitro. Effect of Cross-Linking”. Soc. for 6,752,834 B2 * 6/2004 Geistlich et al. ... 623,23.63 Biomaterials, Apr. 28-May 2, 1999, Providence, R.I. (one page). 6,863,900 B2 * 3/2005 Kadiyala et al. ... ... 424/426 S. Nehrer et al., “Canine Chondrocytes Seeded in Type I and Type II 7,141,072 B2 * 1 1/2006 Geistlich et al. ........... 623/23.74 Collagen Implants Investigated In Vitro”. J. Biomed. Mater. Res. 2001/OO16772 A1 8, 2001 Lee et al. (Appl. Biomater.), 1997, pp. 95-104, vol. 38, John Wiley & Sons, Inc. “Carticel (Autologous cultured chondrocytes): Get in the Game”, FOREIGN PATENT DOCUMENTS Genzyme Tissue Repair, 9 pp., 1998. Menard, C., et al., "Contractile behavior of Smooth muscle actin DE 38 10803 A1 10, 1989 containing osteoblasts in collagen-GAG matrices in vitro: implant DE 1965.4884A. A1 9, 1997 related cell contraction'. Biomaterials, 21 (2000) 1867-1877. EP O171176 A2 2, 1986 FR 2679778 2, 1993 Database WPI, 0.02241043, Derwent Publications Ltd., Jul 26, 1990. JP 2033388 2, 1990 Database WPI, 002241044, Derwent Publications Ltd., Dec. 4, 2001. JP 4-5O1070 A 2, 1992 Database Biosis, 0.02242287. “Lapine and canine bone marrow JP 8-510984 A 11, 1996 Stromal cells contain Smooth muscle actin and contract a collagen JP 2001-333974 4/2001 Slycoasminoglycan matrix'. Dec. 2001. WO WO 83/04177 A1 12/1983 Pieper, J.S., et al., “Development of Tailor-made Collagen WO 90/O1955 A1 3, 1990 glycosaminoglycan Matrices: EDC/NHS Crosslinking, and WO WO90,05755 A1 5, 1990 Ultrastructural Aspects'. Biomaterials, vol. 21, pp. 581-593 (2000). US 9,034,315 B2 Page 3 (56) References Cited D. Mutter et al., “Biomaterial Supports for Colonic Wall Defect Healing”. Biomaterials 17, 1996, pp. 141 1-1415. OTHER PUBLICATIONS T.O. Schneider et al.: “Expression of C-Smooth Muscle Actin in Canine Intervertebral Disc Cells In Situ and in Collagen Stone, K., et al., “Regeneration of Meniscal Cartilage with Use of a Glycosaminoglycan Matrices. In Vitro.” Journal of Orthopaedic Collagen Scaffold'. The Journal of Bone and Joint Surgery, Incor Research, vol.
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