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Review

Investigational regenerative medicine for non-traumatic osteonecrosis of the femoral head: a survey of registered clinical trials

ORCID Icon, , , &
Pages 405-414 | Received 30 Nov 2023, Accepted 28 Feb 2024, Published online: 05 Mar 2024

References

  • Tang C, Wang Y, Lv H, et al. Caution against corticosteroid-based COVID-19 treatment. The Lancet. 2020;395(10239):1759–1760. doi: 10.1016/S0140-6736(20)30749-2
  • Guan WJ, Ni ZY, Hu Y, et al. Clinical characteristics of coronavirus disease 2019 in China. N Engl J Med. 2020;382(18):1708–1720. doi: 10.1056/NEJMoa2002032
  • Sodhi N, Acuna A, Etcheson J, et al. Management of osteonecrosis of the femoral head. Bone Joint J. 2020;102-B(7_Supple_B):122–128. doi: 10.1302/0301-620X.102B7.BJJ-2019-1611.R1
  • Mont MA, Salem HS, Piuzzi NS, et al. Nontraumatic osteonecrosis of the femoral head: where do we stand today?: a 5-year update. Bone Joint J Surg. 2020;102(12):1084–1099. doi: 10.2106/JBJS.19.01271
  • Ando W, Sakai T, Fukushima W, et al. Japanese orthopaedic association 2019 guidelines for osteonecrosis of the femoral head. J Orthopaedic Sci. 2021;26(1):46–68. doi: 10.1016/j.jos.2020.06.013
  • Moya-Angeler J, Gianakos AL, Villa JC, et al. Current concepts on osteonecrosis of the femoral head. World J Orthop. 2015;6(8):590. doi: 10.5312/wjo.v6.i8.590
  • Petek D, Hannouche D, Suva D. Osteonecrosis of the femoral head: pathophysiology and current concepts of treatment. EFORT Open Rev. 2019;4(3):85–97. doi: 10.1302/2058-5241.4.180036
  • Yang S, Halim AY, Werner BC, et al. Does osteonecrosis of the femoral head increase surgical and medical complication rates after total hip arthroplasty? A comprehensive analysis in the United States. Hip Int. 2015;25(3):237–244. doi: 10.5301/hipint.5000224
  • Hart A, Janz V, Trousdale RT, et al. Long-term survivorship of total hip arthroplasty with highly cross-linked polyethylene for osteonecrosis. J Bone Joint Surg. 2019;101(17):1563–1568. doi: 10.2106/JBJS.18.01218
  • Johnson AJ, Mont MA, Tsao AK, et al. Treatment of femoral head osteonecrosis in the United States: 16-year analysis of the nationwide inpatient sample. Clin Orthop Relat Res. 2014 Feb;472(2):617–623.
  • Kuroda Y, Okuzu Y, Kawai T, et al. Difference in therapeutic strategies for joint-preserving surgery for non-traumatic osteonecrosis of the femoral head between the United States and Japan: a review of the literature. Orthop Surg. 2021;13(3):742–748. doi: 10.1111/os.12979
  • Zhao D, Zhang F, Wang B, et al. Guidelines for clinical diagnosis and treatment of osteonecrosis of the femoral head in adults (2019 version). J Ortho Translat. 2020;21:100–110. doi: 10.1016/j.jot.2019.12.004
  • Iwamoto Y. A national interdisciplinary study to develop methods for the diagnosis, treatment and prevention of idiopathic femoral head osteonecrosis. The Ministry of Health. Labour and Welfare’s Intractable Disease Project; 2013. p. 1–250. (in Japanese).
  • De Angelis C, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the international committee of medical journal editors. N Engl J Med. 2004;351(12):1250–1251. doi: 10.1056/NEJMe048225
  • ClinicalTrials.gov. [cited 2023 Oct 15]. Available from: https://www.clinicaltrials.gov/ct2/home
  • ClinicalTrials.gov. FDAAA 801 requirements. [cited 2023 Oct 15]. Available from: https://clinicaltrials.gov/ct2/manage-recs/fdaaa#WhichTrialsMustBeRegistered
  • UMIN CTR. [cited 2023 Oct 15]. Available from: https://www.umin.ac.jp/ctr/index-j.htm
  • Chi CTR [cited 2023 Oct 15]. Available from: http://www.chictr.org.cn
  • ANZCTR. [cited 2023 Oct 15]. Available from: https://www.anzctr.org.au
  • EU. CTR. [cited 2023 Oct 15]. Available from: https://www.clinicaltrialsregister.eu/ctr-search/search
  • Hauzeur JP, De Maertelaer V, Baudoux E, et al. Inefficacy of autologous bone marrow concentrate in stage three osteonecrosis: a randomized controlled double-blind trial. International Orthopaedics (Sicot). 2018;42(7):1429–1435. doi: 10.1007/s00264-017-3650-8
  • Martinot P, Dartus J, Leclerc JT, et al. Hip survival after plain core decompression alone versus bone morphogenetic protein and/or bone marrow reinjection with core decompression for avascular osteonecrosis of the femoral head: a retrospective case control study in ninety two patients. Int Orthop (Sicot). 2020;44(11):2275–2282. doi: 10.1007/s00264-020-04692-w
  • Daltro GC, Fortuna V, de Souza ES, et al. Efficacy of autologous stem cell-based therapy for osteonecrosis of the femoral head in sickle cell disease: a five-year follow-up study. Stem Cell Res Ther. 2015;6(1). doi: 10.1186/s13287-015-0105-2
  • Ma Y, Wang T, Liao J, et al. Efficacy of autologous bone marrow buffy coat grafting combined with core decompression in patients with avascular necrosis of femoral head: a prospective, double-blinded, randomized, controlled study. Stem Cell Res Ther. 2014;5(5). doi: 10.1186/scrt505
  • Li M, Ma Y, Fu G, et al. 10-year follow-up results of the prospective, double-blinded, randomized, controlled study on autologous bone marrow buffy coat grafting combined with core decompression in patients with avascular necrosis of the femoral head. Stem Cell Res Ther. 2020. doi: 10.1186/s13287-020-01810-8
  • Yoon PW, Kang JY, Kim CH, et al. Culture-expanded autologous adipose-derived mesenchymal stem cell treatment for osteonecrosis of the femoral head. Clin Orthop Surg. 2021;13(1):37. doi: 10.4055/cios20128
  • Rocchi M, Del Piccolo N, Mazzotta A, et al. Core decompression with bone chips allograft in combination with fibrin platelet-rich plasma and concentrated autologous mesenchymal stromal cells, isolated from bone marrow: results for the treatment of avascular necrosis of the femoral head after 2 years minimum follow-up. Hip Int. 2020;30(2_suppl):3–12. doi: 10.1177/1120700020964996
  • Gómez-Barrena E, Padilla-Eguiluz NG, Rosset P, et al. Osteonecrosis of the femoral head safely healed with autologous, expanded, bone marrow-derived mesenchymal stromal cells in a multicentric trial with minimum 5 years follow-up. J Clin Med. 2021;10(3):508. doi: 10.3390/jcm10030508
  • Gómez-Barrena E, Padilla-Eguiluz NG, Consortium R. Implantation of autologous expanded mesenchymal stromal cells in hip osteonecrosis through percutaneous forage: evaluation of the operative technique. J Clin Med. 2021;10(4):743. doi: 10.3390/jcm10040743
  • Theruvath AJ, Nejadnik H, Muehe AM, et al. Tracking cell transplants in femoral osteonecrosis with magnetic resonance imaging: a proof-of-concept study in patients. Clin Cancer Res. 2018;24(24):6223–6229. doi: 10.1158/1078-0432.CCR-18-1687
  • Kuroda Y, Asada R, So K, et al. A pilot study of regenerative therapy using controlled release of rhFGF-2 for patients with pre-collapse osteonecrosis of the femoral head. Int Orthop. 2016;40(8):1747–1754. doi: 10.1007/s00264-015-3083-1
  • Kuroda Y, Ito-Ihara T, Abe H, et al. Recombinant human FGF-2 therapy for osteonecrosis of the femoral head: 5-year follow-up. Regenerat Med. 2020;15(11):2261–2271. doi: 10.2217/rme-2020-0148
  • Kuroda Y, Tanaka T, Miyagawa T, et al. Recombinant human FGF-2 for the treatment of early-stage osteonecrosis of the femoral head: TRION, a single-arm, multicenter, phase II trial. Regen Med. 2021;16(6):535–548. doi: 10.2217/rme-2021-0049
  • Bone therapeutics clinical study report. [cited 2021 Sep 10]. Available from: https://www.clinicaltrialsregister.eu/ctr-search/rest/download/result/zip/pdf/2009-012929-11/1
  • Hernigou P, Poignard A, Zilber S, et al. Cell therapy of hip osteonecrosis with autologous bone marrow grafting. Indian J Orthop. 2009;43(1):40. doi: 10.4103/0019-5413.45322
  • Gangji V, De Maertelaer V, Hauzeur JP. Autologous bone marrow cell implantation in the treatment of non-traumatic osteonecrosis of the femoral head: five year follow-up of a prospective controlled study. Bone. 2011;49(5):1005–1009. doi: 10.1016/j.bone.2011.07.032
  • Papakostidis C, Tosounidis TH, Jones E, et al. The role of “cell therapy” in osteonecrosis of the femoral head. Acta Orthop. 2016;87(1):72–78. doi: 10.3109/17453674.2015.1077418
  • Li J, Su P, Li J, et al. Efficacy and safety of stem cell combination therapy for osteonecrosis of the femoral head: a systematic review and meta-analysis. J Healthc Eng. 2021;2021:1–8. doi: 10.1155/2021/9313201
  • Yu PA, Peng KT, Huang TW, et al. Injectable synthetic bone graft substitute combined with core decompression in the treatment of advanced osteonecrosis of the femoral head: a 5-year follow-up. Biomed J. 2015;38(3):257–261. doi: 10.4103/2319-4170.138307
  • Tsao AK, Roberson JR, Christie MJ, et al. Biomechanical and clinical evaluations of a porous tantalum implant for the treatment of early-stage osteonecrosis. J Bone Joint Surg Am. 2005;87:22–27. doi: 10.2106/00004623-200511002-00003
  • Veillette CJ, Mehdian H, Schemitsch EH, et al. Survivorship analysis and radiographic outcome following tantalum rod insertion for osteonecrosis of the femoral head. J Bone Joint Surg Am. 2006;88:48–55. doi: 10.2106/00004623-200611001-00008
  • Floerkemeier T, Thorey F, Daentzer D, et al. Clinical and radiological outcome of the treatment of osteonecrosis of the femoral head using the osteonecrosis intervention implant. Int Ortho (Sicot). 2011;35(4):489–495. doi: 10.1007/s00264-009-0940-9
  • Kuroda Y, Kawai T, Goto K, et al. Clinical application of injectable growth factor for bone regeneration: a systematic review. Inflam Regen. 2019;39(1). doi: 10.1186/s41232-019-0109-x
  • DeVito NJ, Bacon S, Goldacre B. Compliance with legal requirement to report clinical trial results on clinical Trials.Gov: a cohort study. Lancet. 2020;395(10221):361–369. doi: 10.1016/S0140-6736(19)33220-9

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