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 |
ARCO Association Research Circulation Osseous, BM bone marrow, BMMCs bone marrow mononuclear cells, BMMSCs bone marrow mesenchymal stromal cells, CD core decompression, CFU colony forming units, HHS Harris Hip Score, MSCs mesenchymal stromal cells, ON osteonecrosis, ONFH ON of femoral head, pts patients, SCD sickle cell disease