Pesquisadores ligados ao Erasme University Hospital, da Bélgica, publicaram, recentemente, no The Journal of Bone and Joint Surgery (American), um estudo em que investigaram o implante de células mononucleares autólogas de medula óssea em lesões necróticas da cabeça do fêmur, e determinaram o efeito do implante nos sintomas clínicos, bem como no estágio e volume da osteonecrose.
Foram investigados treze pacientes (dezoito quadris) portadores de osteonecrose da cabeça femoral estágios I ou II, de acordo com o sistema da Association Research Circulation Osseous. Os pacientes foram alocados para serem submetidos a descompressão da cabeça femoral (grupo controle) ou para descompressão da cabeça femoral associada ao implante de células mononucleares autólogas de medula óssea (grupo experimental). Tanto os pacientes, como os avaliadores, desconheciam a que grupo cada paciente havia sido alocado. As evoluções primárias analisadas foram segurança do procedimento, sintomas clínicos e progressão da doença.
Após 24 meses, houve redução significante da dor (p=0,021) e dos sintomas articulares medidos através do índice de Lequesne (p=0,001) e do índice WOMAC (p = 0,013) no grupo submetido ao implante de células mononucleares autólogas de medula óssea. Cinco dos oito quadris, alocados no grupo controle, apresentaram deterioração para estágio III, enquanto que, no grupo experimental, apenas um dos dez quadris apresentou esta progressão. Análise de sobrevida mostrou diferença estatisticamente significante do tempo de colapso da cabeça femoral entre os dois grupos (p = 0,016). O implante de células mononucleares autólogas de medula óssea associou-se a efeitos colaterais mínimos.
Portanto, os pesquisadores concluíram que o implante de células mononucleares autólogas de medula óssea é tratamento seguro e eficaz para estágios precoces de osteonecrose da cabeça femoral.
Treatment of Osteonecrosis of the Femoral Head with Implantation of Autologous Bone-Marrow Cells - The Journal of Bone and Joint Surgery (American) 2004; 86: 1153-1160
The Journal of Bone and Joint Surgery (American) 86:1153-1160 (2004)
© 2004 The Journal of Bone and Joint Surgery, Inc.
Treatment of Osteonecrosis of the Femoral Head with Implantation of Autologous Bone-Marrow Cells
A Pilot Study
Valérie Gangji, MD1, Jean-Philippe Hauzeur, MD, PhD1, Celso Matos, MD1, Viviane De Maertelaer, PhD2, Michel Toungouz, MD, PhD1 and Micheline Lambermont, PharmD1
1 Department of Rheumatology and Physical Medicine (V.G. and J.-P.H.), Department of Radiology (C.M.), and the Cellular and Molecular Therapy Unit (M.T. and M.L.), Erasme University Hospital, 808 Route de Lennik, 1070 Brussels, Belgium. E-mail address for V. Gangji: vgangji@ulb.ac.be
2 Department of Biostatistics, Institut de Recherche Interdisciplinaire en Biologie Humaine et Moleculaire, School of Medicine, Université Libre de Bruxelles, 808 Route de Lennik, 1070 Brussels, Belgium
Investigation performed at the Department of Rheumatology and Physical Medicine, the Department of Radiology, and the Cellular and Molecular Therapy Unit, Erasme University Hospital, Brussels, Belgium
Background: Aseptic nontraumatic osteonecrosis of the femoral head is a disorder that can lead to femoral head collapse and the need for total hip replacement. Since osteonecrosis may be a disease of mesenchymal cells or bone cells, the possibility has been raised that bone marrow containing osteogenic precursors implanted into a necrotic lesion of the femoral head may be of benefit in the treatment of this condition. For this reason, we studied the implantation of autologous bone-marrow mononuclear cells in a necrotic lesion of the femoral head to determine the effect on the clinical symptoms and the stage and volume of osteonecrosis.
Methods: We studied thirteen patients (eighteen hips) with stage-I or II osteonecrosis of the femoral head, according to the system of the Association Research Circulation Osseous. The hips were allocated to a program of either core decompression (the control group) or core decompression and implantation of autologous bone-marrow mononuclear cells (the bone-marrow-graft group). Both patients and assessors were blind with respect to treatment-group assignment. The primary outcomes studied were safety, clinical symptoms, and disease progression.
Results: After twenty-four months, there was a significant reduction in pain (p = 0.021) and in joint symptoms measured with the Lequesne index (p = 0.001) and the WOMAC index (p = 0.013) within the bone-marrow-graft group. At twenty-four months, five of the eight hips in the control group had deteriorated to stage III, whereas only one of the ten hips in the bone-marrow-graft group had progressed to this stage. Survival analysis showed a significant difference in the time to collapse between the two groups (p = 0.016). Implantation of bone-marrow mononuclear cells was associated with only minor side effects.
Conclusions: Implantation of autologous bone-marrow mononuclear cells appears to be a safe and effective treatment for early stages of osteonecrosis of the femoral head. Although the findings of this study are promising, their interpretation is limited because of the small number of patients and the short duration of follow-up. Further study is needed to confirm the results.
Level of Evidence: Therapeutic study, Level II-1 (prospective cohort study). See Instructions to Authors for a complete description of levels of evidence.
