Ricardo Bastos Filho1, Simone Lermontov2, Radovan Borojevic3, Paulo Cezar Schott4, Vinicius Schott Gameiro4, José Mauro Granjeiro5. 1. Medical Sciences Graduate Program, Hospital Universitário Antônio Pedro, Universidade Federal Fluminense - Niterói, RJ, Brazil. 2. Nursing School, Universidade Federal Fluminense - Niterói, RJ, Brazil. 3. Institute of Biomedical Sciences, Universidade Federal do Rio de Janeiro - Rio de Janeiro, RJ, Brazil. 4. Department of General and Specialized Surgery, Hospital Universitário Antônio Pedro, Universidade Federal Fluminense - Niterói, RJ, Brazil. 5. Cell Therapy Center and Biology Institute, Biology Institute, Universidade Federal Fluminense - Niterói, RJ, Brazil and Bioengineering Division, National Institute of Metrology, Quality and Technology (Inmetro) - Duque de Caxias, RJ, Brazil.
Abstract
OBJECTIVE: To assess the safety and efficiency of cell therapy for pseudarthrosis. Implant of the bone marrow aspirate was compared to mononuclear cells purified extemporaneously using the Sepax(®) equipment. METHODS: Six patients with nonunion of the tibia or femur were treated. Four received a percutaneous infusion of autologous bone marrow aspirated from the iliac crest, and two received autologous bone marrow mononuclear cells separated from the aspirate with the Sepax(®). The primary fixation method was unchanged, and the nonunion focus was not exposed. Physical examination and radiographies were performed 2, 4 and 6 months after the treatment by the same physician. After consolidation of the fracture the satisfaction of the patients was estimated using the adapted QALY scale. RESULTS: No complications occurred as a result of the referred procedures. Bone consolidation was obtained in all cases within 3 to 24 weeks. The degree of patient satisfaction before and after bone consolidation was assessed, with the average value increasing from two to nine (p=0.0156). CONCLUSION: We conclude that the proposed method is effective and safe for the treatment of nonunion of long bones regardless of the stabilization method used. Level of Evidence II, Prospective Comparative Study.
OBJECTIVE: To assess the safety and efficiency of cell therapy for pseudarthrosis. Implant of the bone marrow aspirate was compared to mononuclear cells purified extemporaneously using the Sepax(®) equipment. METHODS: Six patients with nonunion of the tibia or femur were treated. Four received a percutaneous infusion of autologous bone marrow aspirated from the iliac crest, and two received autologous bone marrow mononuclear cells separated from the aspirate with the Sepax(®). The primary fixation method was unchanged, and the nonunion focus was not exposed. Physical examination and radiographies were performed 2, 4 and 6 months after the treatment by the same physician. After consolidation of the fracture the satisfaction of the patients was estimated using the adapted QALY scale. RESULTS: No complications occurred as a result of the referred procedures. Bone consolidation was obtained in all cases within 3 to 24 weeks. The degree of patient satisfaction before and after bone consolidation was assessed, with the average value increasing from two to nine (p=0.0156). CONCLUSION: We conclude that the proposed method is effective and safe for the treatment of nonunion of long bones regardless of the stabilization method used. Level of Evidence II, Prospective Comparative Study.
Authors: David H Kim; Richard Rhim; Ling Li; Juli Martha; Bryan H Swaim; Robert J Banco; Louis G Jenis; Scott G Tromanhauser Journal: Spine J Date: 2009-06-18 Impact factor: 4.166
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