Table 1 Overview of clinical studies on MSC- or auto-BM-MNC therapy in ON
Reference year | Diagnosis | Intervention/ source | Study design | Cohort | Classification | Cell dose | Follow-up | Results |
|---|---|---|---|---|---|---|---|---|
Müller et al. 2008 [14] | ONFH + ON of the knee | CD + autologous BM MSCs | Pilot study | pts = 5 | not specified | MSCs 31 × 106–240 × 106 | 16 mo | Clinical improvement, formation of mineralized bone in the necrotic area |
Zhao et al. 2012 [35] | ONFH | CD ± autologous BM MSCs | Single center randomized clinical trial | pts = 100 | ARCO IC-IIC | MSCs 2 × 106 | 60 mo | 2 of 53 BMMSC-treated hips progressed; in CD group 10 of 44 hips progressed; significant improvement of HHS in BMMSC group |
Chen et al. 2016 [49] | ONFH (steroid, alcohol, idiopathic) | Intra-arterial infusion of human umbilical cord-derived MSCs | Retrospective analysis | pts = 9 | ARCO II-IIIa | MSCs 5 × 106–1 × 107 | 3 y | Significant reduction of the necrotic volume on MRI 12/24 months after application |
Hernigou et al. 2009 [54] | ONFH (steroid, alcohol, SCD | CD + reduced volume autologous BM | Single center study | pts = 342 hips = 534 | Steinberg I-II | CFUs 24 × 103 | 8–18 y | Total hip replacement in 94 hips (n = 534); total resolution of ON in 69 hips |
Daltro et al. 2015 [58] | ONFH (SCD) | CD + autologous BMMCs | Phase I/II prospective trial | pts = 89 | Ficat 0-IIB | CFU-F 2.7 ± 1.4 × 104/cells | 60 mo | Significant improvement in HHS (p = 0.0005); 3.7% no satisfactory outcome |
Gangji et al. 2011 [55] | ONFH (steroid, alcohol, idiopathic) | CD ± autologous BMMC | Controlled double blind pilot study | pts = 19 hips = 24 BM hips = 13 | ARCO I-II | BMMCs 1.9 ± 0.2 × 109: - CD34+ 1 ± 0.1% - CFU 92.6 ± 22.4 × 107/cells | 60 mo | Significant reduction in pain/ joint symptoms and reduced the incidence of fractural stages; significant difference in time to failure |
Sen et al 2012 [56] | ONFH (traumatic, nontraumatic) | CD ± autologous BM concentrate | Randomized control study | pts = 40 Hips = 51 | ARCO I-II | BMMCs 5 × 108: CD34 + 5 × 107 |  | Significant clinical improvement in HHS |
Martin et al 2013 [53] | ONFH (steroid, alcohol, idiopathic) | Minimally invasive decompression + concentrated BM aspirate | Retrospective review | hips = 77 | Ficat I-II | not specified | 17 mo | Progression in 16 hips (21%); significant pain relief in 86% of patients (n = 60) |
Civinini et al 2012 [59] | ONFH | CD + autologous BM concentrate and backfilling with bioceramic | Prospective single center trial | pts = 31 hips = 37 | Steinberg IC-IIIA | not specified | 20.6 mo | Improvement in HHS; clinical success rate 86.5%, failure rate 3.3% in pre-collapse group |
Pepke et al 2016 [52] | Non-traumatic ONFH | CD ± autologous BM concentrate | Randomized prospective study | pts = 24 hips = 25 | ARCO II | BMMCs 118.9 ± 15.1 × 106 cells/ml | 24 mo | No difference in clinical outcome and head survival rate between both groups |