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Table 1 Overview of clinical studies on MSC- or auto-BM-MNC therapy in ON

From: Mesenchymal stromal cells for osteonecrosis

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
  1. 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