Treatment of Alveolar Bone Defects Using Aastrom Biosciences Autologous Tissue Repair Cell Therapy

Summary

The purpose of this research is to determine if a subject's own bone marrow tissue can help regenerate bone in the area of his/her jaw where a tooth has been removed using Tissue Repair Cell (TRC) Therapy.

Timeline

Start

2008-06

Primary completion

2011-12

Completion

2012-05

Publications

• Background Albrektsson T, Branemark PI, Hansson HA, Lindstrom J. Osseointegrated titanium implants. Requirements for ensuring a long-lasting, direct bone-to-implant anchorage in man. Acta Orthop Scand. 1981;52(2):155-70. doi: 10.3109/17453678108991776.
• Background Albrektsson T, Lekholm U. Osseointegration: current state of the art. Dent Clin North Am. 1989 Oct;33(4):537-54.
• Background Amler MH. The time sequence of tissue regeneration in human extraction wounds. Oral Surg Oral Med Oral Pathol. 1969 Mar;27(3):309-18. doi: 10.1016/0030-4220(69)90357-0. No abstract available.
• Background Atwood DA. Reduction of residual ridges: a major oral disease entity. J Prosthet Dent. 1971 Sep;26(3):266-79. doi: 10.1016/0022-3913(71)90069-2. No abstract available.
• Background Atwood DA, Coy WA. Clinical, cephalometric, and densitometric study of reduction of residual ridges. J Prosthet Dent. 1971 Sep;26(3):280-95. doi: 10.1016/0022-3913(71)90070-9. No abstract available.
• Background Caldwell J, Palsson BO, Locey B, Emerson SG. Culture perfusion schedules influence the metabolic activity and granulocyte-macrophage colony-stimulating factor production rates of human bone marrow stromal cells. J Cell Physiol. 1991 May;147(2):344-53. doi: 10.1002/jcp.1041470221.
• Background Cardaropoli G, Araujo M, Hayacibara R, Sukekava F, Lindhe J. Healing of extraction sockets and surgically produced - augmented and non-augmented - defects in the alveolar ridge. An experimental study in the dog. J Clin Periodontol. 2005 May;32(5):435-40. doi: 10.1111/j.1600-051X.2005.00692.x.
• Background Cardaropoli G, Araujo M, Lindhe J. Dynamics of bone tissue formation in tooth extraction sites. An experimental study in dogs. J Clin Periodontol. 2003 Sep;30(9):809-18. doi: 10.1034/j.1600-051x.2003.00366.x.
• Background Carlsson L, Rostlund T, Albrektsson B, Albrektsson T, Branemark PI. Osseointegration of titanium implants. Acta Orthop Scand. 1986 Aug;57(4):285-9. doi: 10.3109/17453678608994393.
• Background Cochran D. Implant therapy I. Ann Periodontol. 1996 Nov;1(1):707-91. doi: 10.1902/annals.1996.1.1.707. No abstract available.
• Background Colter DC, Class R, DiGirolamo CM, Prockop DJ. Rapid expansion of recycling stem cells in cultures of plastic-adherent cells from human bone marrow. Proc Natl Acad Sci U S A. 2000 Mar 28;97(7):3213-8. doi: 10.1073/pnas.97.7.3213.
• Background De Kok IJ, Drapeau SJ, Young R, Cooper LF. Evaluation of mesenchymal stem cells following implantation in alveolar sockets: a canine safety study. Int J Oral Maxillofac Implants. 2005 Jul-Aug;20(4):511-8.
• Background Evian CI, Rosenberg ES, Coslet JG, Corn H. The osteogenic activity of bone removed from healing extraction sockets in humans. J Periodontol. 1982 Feb;53(2):81-5. doi: 10.1902/jop.1982.53.2.81.
• Background Fiorellini JP, Howell TH, Cochran D, Malmquist J, Lilly LC, Spagnoli D, Toljanic J, Jones A, Nevins M. Randomized study evaluating recombinant human bone morphogenetic protein-2 for extraction socket augmentation. J Periodontol. 2005 Apr;76(4):605-13. doi: 10.1902/jop.2005.76.4.605.
• Background Friedenstein AJ, Ivanov-Smolenski AA, Chajlakjan RK, Gorskaya UF, Kuralesova AI, Latzinik NW, Gerasimow UW. Origin of bone marrow stromal mechanocytes in radiochimeras and heterotopic transplants. Exp Hematol. 1978 May;6(5):440-4.
• Background Fugazzotto PA. Success and failure rates of osseointegrated implants in function in regenerated bone for 72 to 133 months. Int J Oral Maxillofac Implants. 2005 Jan-Feb;20(1):77-83.
• Background Gao J, Dennis JE, Solchaga LA, Awadallah AS, Goldberg VM, Caplan AI. Tissue-engineered fabrication of an osteochondral composite graft using rat bone marrow-derived mesenchymal stem cells. Tissue Eng. 2001 Aug;7(4):363-71. doi: 10.1089/10763270152436427.
• Background Iasella JM, Greenwell H, Miller RL, Hill M, Drisko C, Bohra AA, Scheetz JP. Ridge preservation with freeze-dried bone allograft and a collagen membrane compared to extraction alone for implant site development: a clinical and histologic study in humans. J Periodontol. 2003 Jul;74(7):990-9. doi: 10.1902/jop.2003.74.7.990.
• Background Ishaug-Riley SL, Crane GM, Gurlek A, Miller MJ, Yasko AW, Yaszemski MJ, Mikos AG; New Collective Author. Ectopic bone formation by marrow stromal osteoblast transplantation using poly(DL-lactic-co-glycolic acid) foams implanted into the rat mesentery. J Biomed Mater Res. 1997 Jul;36(1):1-8. doi: 10.1002/(sici)1097-4636(199707)36:13.0.co;2-p.
• Background Jeffcoat MK, Reddy MS. Advances in measurements of periodontal bone and attachment loss. Monogr Oral Sci. 2000;17:56-72. doi: 10.1159/000061636.
• Background Kaigler D, Krebsbach PH, Wang Z, West ER, Horger K, Mooney DJ. Transplanted endothelial cells enhance orthotopic bone regeneration. J Dent Res. 2006 Jul;85(7):633-7. doi: 10.1177/154405910608500710.
• Background Kaigler D, Mooney D. Tissue engineering's impact on dentistry. J Dent Educ. 2001 May;65(5):456-62.
• Background Krebsbach PH, Kuznetsov SA, Bianco P, Robey PG. Bone marrow stromal cells: characterization and clinical application. Crit Rev Oral Biol Med. 1999;10(2):165-81. doi: 10.1177/10454411990100020401.
• Background Krebsbach PH, Kuznetsov SA, Satomura K, Emmons RV, Rowe DW, Robey PG. Bone formation in vivo: comparison of osteogenesis by transplanted mouse and human marrow stromal fibroblasts. Transplantation. 1997 Apr 27;63(8):1059-69. doi: 10.1097/00007890-199704270-00003.
• Background Langer R, Vacanti JP. Tissue engineering. Science. 1993 May 14;260(5110):920-6. doi: 10.1126/science.8493529.
• Background Lekovic V, Camargo PM, Klokkevold PR, Weinlaender M, Kenney EB, Dimitrijevic B, Nedic M. Preservation of alveolar bone in extraction sockets using bioabsorbable membranes. J Periodontol. 1998 Sep;69(9):1044-9. doi: 10.1902/jop.1998.69.9.1044.
• Background Mankani MH, Kuznetsov SA, Wolfe RM, Marshall GW, Robey PG. In vivo bone formation by human bone marrow stromal cells: reconstruction of the mouse calvarium and mandible. Stem Cells. 2006 Sep;24(9):2140-9. doi: 10.1634/stemcells.2005-0567. Epub 2006 Jun 8.
• Background Marei MK, Nouh SR, Saad MM, Ismail NS. Preservation and regeneration of alveolar bone by tissue-engineered implants. Tissue Eng. 2005 May-Jun;11(5-6):751-67. doi: 10.1089/ten.2005.11.751.
• Background Misch CE. Bone classification, training keys to implant success. Dent Today. 1989 May;8(4):39-44. No abstract available.
• Background Nevins M, Giannobile WV, McGuire MK, Kao RT, Mellonig JT, Hinrichs JE, McAllister BS, Murphy KS, McClain PK, Nevins ML, Paquette DW, Han TJ, Reddy MS, Lavin PT, Genco RJ, Lynch SE. Platelet-derived growth factor stimulates bone fill and rate of attachment level gain: results of a large multicenter randomized controlled trial. J Periodontol. 2005 Dec;76(12):2205-15. doi: 10.1902/jop.2005.76.12.2205.
• Background Pecora AL, Stiff P, Jennis A, Goldberg S, Rosenbluth R, Price P, Goltry KL, Douville J, Armstrong RD, Smith AK, Preti RA. Prompt and durable engraftment in two older adult patients with high risk chronic myelogenous leukemia (CML) using ex vivo expanded and unmanipulated unrelated umbilical cord blood. Bone Marrow Transplant. 2000 Apr;25(7):797-9. doi: 10.1038/sj.bmt.1702222.
• Background Pecora AL, Stiff P, LeMaistre CF, Bayer R, Bachier C, Goldberg SL, Parthasarathy M, Jennis AA, Smith AK, Douville J, Chen B, Armstrong RD, Mandalam RK, Preti R. A phase II trial evaluating the safety and effectiveness of the AastromReplicell system for augmentation of low-dose blood stem cell transplantation. Bone Marrow Transplant. 2001 Aug;28(3):295-303. doi: 10.1038/sj.bmt.1703137.
• Background Prockop DJ, Azizi SA, Colter D, Digirolamo C, Kopen G, Phinney DG. Potential use of stem cells from bone marrow to repair the extracellular matrix and the central nervous system. Biochem Soc Trans. 2000;28(4):341-5.
• Background Reynolds MA, Aichelmann-Reidy ME, Branch-Mays GL, Gunsolley JC. The efficacy of bone replacement grafts in the treatment of periodontal osseous defects. A systematic review. Ann Periodontol. 2003 Dec;8(1):227-65. doi: 10.1902/annals.2003.8.1.227.
• Background Schenk RK, Buser D, Hardwick WR, Dahlin C. Healing pattern of bone regeneration in membrane-protected defects: a histologic study in the canine mandible. Int J Oral Maxillofac Implants. 1994 Jan-Feb;9(1):13-29.
• Background Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.
• Background Schwartz RM, Palsson BO, Emerson SG. Rapid medium perfusion rate significantly increases the productivity and longevity of human bone marrow cultures. Proc Natl Acad Sci U S A. 1991 Aug 1;88(15):6760-4. doi: 10.1073/pnas.88.15.6760.
• Background Seo BM, Miura M, Gronthos S, Bartold PM, Batouli S, Brahim J, Young M, Robey PG, Wang CY, Shi S. Investigation of multipotent postnatal stem cells from human periodontal ligament. Lancet. 2004 Jul 10-16;364(9429):149-55. doi: 10.1016/S0140-6736(04)16627-0.
• Background Shang Q, Wang Z, Liu W, Shi Y, Cui L, Cao Y. Tissue-engineered bone repair of sheep cranial defects with autologous bone marrow stromal cells. J Craniofac Surg. 2001 Nov;12(6):586-93; discussion 594-5. doi: 10.1097/00001665-200111000-00017.
• Background Stanford CM. Bone quantity and quality: are they relevant predictors of implant outcomes? Int J Prosthodont. 2003;16 Suppl:43-5; discussion 47-51. No abstract available.
• Background Taba M Jr, Jin Q, Sugai JV, Giannobile WV. Current concepts in periodontal bioengineering. Orthod Craniofac Res. 2005 Nov;8(4):292-302. doi: 10.1111/j.1601-6343.2005.00352.x.
• Background Wang Z, Song J, Taichman RS, Krebsbach PH. Ablation of proliferating marrow with 5-fluorouracil allows partial purification of mesenchymal stem cells. Stem Cells. 2006 Jun;24(6):1573-82. doi: 10.1634/stemcells.2005-0399.
• Background Wenzel A. Bitewing and digital bitewing radiography for detection of caries lesions. J Dent Res. 2004;83 Spec No C:C72-5. doi: 10.1177/154405910408301s14.
• Kaigler D, Pagni G, Park CH, Braun TM, Holman LA, Yi E, Tarle SA, Bartel RL, Giannobile WV. Stem cell therapy for craniofacial bone regeneration: a randomized, controlled feasibility trial. Cell Transplant. 2013;22(5):767-77. doi: 10.3727/096368912X652968.

Drugs

Indications