scholarly journals Phases 1–3 Clinical Trials Using Adult Stem Cells in Osteonecrosis and Nonunion Fractures

2010 ◽  
Vol 2010 ◽  
pp. 1-4 ◽  
Author(s):  
Jean-Philippe Hauzeur ◽  
Valérie Gangji

Nonunion fractures and aseptic bone necrosis are two pathological conditions having some impairment of the cellular part of the repair: a reduction of MSC and of the osteoblastic activation. Both are good candidates for cell-based therapies using stem cells. We made a review of the published human trials. Only autologous bone marrow aspirate implantation was until now used. In Nonunion, a direct injection—15 to 150 ml—was made in 4 case series studies. In another, the bone marrow aspirate was concentrated before injection. The results were good. In bone necrosis, only one level 1 study was published. The results at 24 months were positive in terms of reduction of the necrosis and appearance of collapse. In 3 case series studies, a treatment with concentrated bone marrow aspirates was deemed useful with good results in 76 to 96%. These results are interesting but need confirmation by controlled studies.

2020 ◽  
pp. 219256822094847
Author(s):  
Patrick C. Hsieh ◽  
Andrew S. Chung ◽  
Darrel Brodke ◽  
Jong-Beom Park ◽  
Andrea C. Skelly ◽  
...  

Study Design: Systematic review. Objectives: To systematically review, critically appraise and synthesize evidence on use of stem cells from autologous stem cells from bone marrow aspirate, adipose, or any other autologous sources for fusion in the cervical spine compared with other graft materials. Methods: A systematic search of PubMed/MEDLINE was conducted for literature published through October 31, 2018 and through February 20, 2020 for EMBASE and ClinicalTrials.gov comparing autologous cell sources for cervical spine fusion to other graft options. Results: From 36 potentially relevant citations identified, 10 studies on cervical fusion met the inclusion criteria set a priori. Two retrospective cohort studies, one comparing cancellous bone marrow (CBM) versus hydroxyapatite (HA) and the other bone marrow aspirate (BMA) combined with autograft and HA versus autograft and HA alone, were identified. No statistical differences were seen between groups in either study for improvement in function, symptoms, or fusion; however, in the study evaluating BMA, the authors reported a statistically greater fusion rate and probability of fusion over time in the BMA versus the non-BMA group. Across case series evaluating BMA, authors reported improved function and pain and fusion ranged from 84% to 100% across the studies. In general, complications were poorly reported. Conclusions: The overall quality (strength) of evidence of effectiveness and safety of autologous BMA for cervical arthrodesis in the current available literature was very low. Based on currently available data, firm conclusions regarding the effectiveness or safety of BMA in cervical fusions cannot be made.


2017 ◽  
Vol 2017 ◽  
pp. 1-8 ◽  
Author(s):  
Takeshi Makihara ◽  
Tomokazu Yoshioka ◽  
Hisashi Sugaya ◽  
Katsuya Aoto ◽  
Hiroshi Wada ◽  
...  

No studies have examined the transplantation of a bone marrow aspirate (BMA) containing mesenchymal stem cells (MSCs) combined with human parathyroid hormone 1-34 (hPTH1-34) administration. Therefore, we evaluated the feasibility and efficacy of autologous BMA transplantation combined with hPHT1-34 administration in a bone necrosis model. The metatarsal bones of rabbits were necrotized using liquid nitrogen, and the rabbits received a BMA transplantation or saline injection followed by hPTH1-34 (30 μg/kg) or saline administration three times per week (n = 3-4 per group). The rabbits were euthanized at 12 weeks after the initiation of treatment. No systemic adverse effects or local neoplastic lesions were observed. Importantly, the rabbits in the BMA transplantation plus hPTH1-34 group showed the highest bone volumes and histological scores of new bone. These data confirmed the feasibility of BMA transplantation combined with hPTH1-34, at least during the experimental period. The observed efficacy may be explained by a synergistic effect from the stimulation of MSC differentiation to osteoblasts with hPTH1-34-mediated suppression of apoptosis in osteoblasts. These results indicate the promising potential for BMA transplantation combined with hPTH1-34 administration in bone necrosis treatment. Longer term experiments are needed to confirm the safety of this therapeutic strategy.


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