Early efficacy evaluation of mesenchymal stromal cells (MSC) combined to biomaterials to treat long bone non-unions
| العنوان: | Early efficacy evaluation of mesenchymal stromal cells (MSC) combined to biomaterials to treat long bone non-unions |
|---|---|
| المؤلفون: | Pierre Layrolle, Sandrine Fleury, Massimo Dominici, M.N. Fernández, Norma G. Padilla-Eguiluz, Gabriela Ciapetti, Hélène Rouard, Luc Sensebé, Eduardo García-Rey, Hubert Schrezenmeier, Julien Stanovici, Markus Rojewski, Cristina Avendaño-Solá, José Cordero-Ampuero, Elena Veronesi, Christian Ehrnthaller, Tiziana Montemurro, Nicola Baldini, Rosaria Giordano, Charles Henri Flouzat-Lachaniette, Ramin Lotfi, Markus Huber-Lang, Davide Maria Donati, Benedetta Spazzoli, Philippe Hernigou, Nathalie Chevallier, Enrique Gómez-Barrena, Philippe Rosset, Jose Rafael Cabrera, Carmen Panaitescu, Florian Gebhard, Juan Carlos Rubio-Suárez, Marta Dominguez García-Simón, Rosa Gonzalo-Daganzo |
| المساهمون: | UAM. Departamento de Cirugía, UAM. Departamento de Farmacología, UAM. Departamento de Medicina, Instituto de Investigación Sanitaria Hospital Universitario de La Paz (IdiPAZ), Gomez-Barrena E., Padilla-Eguiluz N., Rosset P., Gebhard F., Hernigou P., Baldini N., Rouard H., Sensebe L., Gonzalo-Daganzo R.-M., Giordano R., Garcia-Rey E., Cordero-Ampuero J., Rubio-Suarez J.C., Garcia-Simon M.D., Stanovici J., Ehrnthaller C., Huber-Lang M., Flouzat-Lachaniette C.H., Chevallier N., Donati D.M., Spazzoli B., Ciapetti G., Fleury S., Fernandez M.-N., Cabrera J.-R., Avendano-Sola C., Montemurro T., Panaitescu C., Veronesi E., Rojewski M.T., Lotfi R., Dominici M., Schrezenmeier H., Layrolle P. |
| المصدر: | Biblos-e Archivo. Repositorio Institucional de la UAM instname Biblos-e Archivo: Repositorio Institucional de la UAM Universidad Autónoma de Madrid |
| بيانات النشر: | Elsevier BV, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | Male, Clinical consolidation, Long bone, Biocompatible Materials, Fractures, Bone, 0302 clinical medicine, Osteogenesis, Medicine, Femur, General Environmental Science, Fracture Healing, 2. Zero hunger, 030222 orthopedics, Consolidation (soil), Middle Aged, 3. Good health, Europe, Treatment Outcome, medicine.anatomical_structure, Radiological weapon, Female, Adult, medicine.medical_specialty, Bioceramic, Efficacy, Medicina, Subgroup analysis, Bone healing, Mesenchymal Stem Cell Transplantation, Transplantation, Autologous, Non-union, MSC, Radiological consolidation, 03 medical and health sciences, Humans, Bioceramics, Clinical Consolidation, Long Bone, Radiological Consolidation, Treatment, Tibia, business.industry, Mesenchymal Stem Cells, 030208 emergency & critical care medicine, Humerus, Confidence interval, Surgery, Radiography, Clinical trial, Fractures, Ununited, General Earth and Planetary Sciences, business, Body mass index |
| الوصف: | Artículo con numerosos autores, sólo se recogen el primero y los pertenecientes a la UAM Background and study aim: Advanced therapy medicinal products (ATMP) frequently lack of clinical data on efficacy to substantiate a future clinical use. This study aims to evaluate the efficacy to heal long bone delayed unions and non-unions, as secondary objective of the EudraCT 2011-005441-13 clinical trial, through clinical and radiological bone consolidation at 3, 6 and 12 months of follow-up, with subgroup analysis of affected bone, gender, tobacco use, and time since the original fracture. Patients and methods: Twenty-eight patients were recruited and surgically treated with autologous bone marrow derived mesenchymal stromal cells expanded under Good Manufacturing Practices, combined to bioceramics in the surgical room before implantation. Mean age was 39 ±13 years, 57% were males, and mean Body Mass Index 27 ±7. Thirteen (46%) were active smokers. There were 11 femoral, 4 humeral, and 13 tibial non-unions. Initial fracture occurred at a mean ±SD of 27.9 ±31.2 months before recruit- ment. Efficacy results were expressed by clinical consolidation (no or mild pain if values under 30 in VAS scale), and by radiological consolidation with a REBORNE score over 11/16 points (value of or above 0.6875). Means were statistically compared and mixed models for repeated measurements estimated the mean and confidence intervals (95%) of the REBORNE Bone Healing scale. Clinical and radiological con- solidation were analyzed in the subgroups with Spearman correlation tests (adjusted by Bonferroni). Results: Clinical consolidation was earlier confirmed, while radiological consolidation at 3 months was 25.0% (7/28 cases), at 6 months 67.8% (19/28 cases), and at 12 months, 92.8% (26/28 cases including the drop-out extrapolation of two failures). Bone biopsies confirmed bone formation surrounding the bioce- ramic granules. All locations showed similar consolidation, although this was delayed in tibial non-unions. No significant gender difference was found in 12-month consolidation (95% confidence). Higher consoli- dation scale values were seen in non-smoking patients at 6 ( p = 0.012, t -test) and 12 months ( p = 0.011, t -test). Longer time elapsed after the initial fracture did not preclude the occurrence of consolidation. Conclusion: Bone consolidation was efficaciously obtained with the studied expanded hBM-MSCs com- bined to biomaterials, by clinical and radiological evaluation, and confirmed by bone biopsies, with lower consolidation scores in smokers This research received funding from the European Union’s Sev- enth Framework Programme ( FP7/FP7-HEALTH-2009 ) with the RE- BORNE Project (under G.A. 241876), and the European Union’s Horizon 2020 Programme ( H2020-SC1 2016-2017 ), with the OR- THOUNION Project (under G.A. 7333288) |
| وصف الملف: | application/pdf; STAMPA |
| تدمد: | 0020-1383 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::73841c829c343e255a437d92a3e53802Test https://doi.org/10.1016/j.injury.2020.02.070Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....73841c829c343e255a437d92a3e53802 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 00201383 |
|---|