Article Figures & Data
Figures
- Figure 1
Preferred Reporting Items for Systematic Reviews and Meta-Analysis flowchart.
- Figure 2
Risk of bias of included randomized controlled trials.
- Figure 3
Oswestry Disability Index forest plot.
- Figure 4
Visual analog scale forest plot.
- Figure 5
Oswestry Disability Index improvement with bone marrow aspirate concentrate.
- Figure 6
Visual analog scale improvement with bone marrow aspirate concentrate.
- Figure 7
Pfirmann improvement.
Tables
Criteria Lewandrowski et al, 202315 Wollf et al, 202016 Pettine et al, 201717 Atluri et al, 202118 Orozco et al, 201119 Kumar et al, 201720 A clearly stated aim 2 1 2 2 2 2 Inclusion of consecutive patients 2 2 2 2 2 2 Prospective collection of data 0 0 2 2 2 2 Endpoint appropriate to the aim of the study 2 2 2 2 2 2 Unbiased assessment of the study endpoint 1 1 0 0 1 1 Follow-up period appropriate to the aim of the study 2 2 2 2 2 2 Loss of follow-up < 5% 0 1 2 1 2 2 Prospective calculation of the study size 2 2 2 2 1 2 Additional criteria for comparative studies An adequate control group NA NA NA 2 NA NA Contemporary group NA NA NA 2 NA NA Baseline equivalent of groups NA NA NA 2 NA NA Adequate statistical analysis NA NA NA 2 NA NA Total 11 11 14 21 14 15 Abbreviation: NA, not applicable.
Note: Low risk of bias : 13–16 (noncomparative studies), 20–24 (comparative studies); moderate risk of bias: 9–12 (noncomparative studies), 15–19 (comparative studies); high risk of bias: 0–8 (noncomparative studies), 0–14 (comparative studies).
Study Study Design (Level of Evidence) Sample Size and Demographic Follow-Up, mo Type and Site of Insertion Dose, Cells (mean CFU-F) Main Results Radiological Results Lewandrowski et al, 202315 Retrospective observational cohort (II) N = 33, mean age = 47.6 y, and M:F = 18:15 24 Allogeneic polyclonal MSC, intradiscal 5 × 106 allogeneic polyclonal MSC + 1% HA ODI score
Baseline 44.81; 1 mo 19.7; 3 mo 15.38; 6 mo 13.48; 12 mo 11.8; 24 mo 6.07 (P < 0.001)
Baseline 82.2; 1 mo 33.1; 3 mo 25.7; 6 mo 20.3; 12 mo 18.1; 24 mo 17.4 (P < 0.001)
Baseline: Pfirrmann grade (mean ± SD): 4.06 ± 0.72
Result: 3.65 ± 0.81Wolff et al, 202016 Retrospective pilot study (II) N = 33, mean age = 45 y, and
M:F = 19:1412 BMC, Intradiscal 3 mL, cells NA ODI improvement from baseline
2 wk 4.2%, 6–8 wk 26.7%; 3 mo 36.4%; 6 mo 55.6%; 12 mo 30.8%
2 wk 13.8%, 6–8 wk 45.8%; 3 mo 41.1%; 6 mo 23.5%; 12 mo 38.9%
NA Pettine et al, 201717 Prospective, nonrandomized (II) N = 26, mean age = 40 y, and
M:F = 11:1536 Autologous BMC, Intradiscal 2–3 mL, 121 × 106 per mL (2,713 per mL) ODI score
Baseline 56.7; 36 mo 17.5 (P < 0.001)
Baseline 82.1; 36 mo 21.9 (P < 0.001)
Baseline:
Pfirrmann Grade IV = 4,
Grade V = 11,
Grade VI = 15, and
Grade VII = 10.
Result: 8 of 20 patients had improved Pfirrmann gradeAtluri et al, 202118 Open label, prospective controlled study (II) N = (40 intervention/40 control), mean age = 60 y, and M:F = NA 12 Autologous bone marrow MSC; intradiscal, intraepidural, facet joint, and SI joint 2 mL (each level), 239.3 × 106 per mL (4,987 per mL) ODI score, intervention vs control
Baseline 46.1 vs 44.3; 1 mo 33.4 vs 45.9; 3 mo 28.8 vs 47.3; 6 mo 29.9 vs 48.9; 12 mo 31.1 vs 49.5 (P < 0.001)
At baseline 71 vs 66; 1 mo 38 vs 68; 3 mo 31 vs 69; 6 mo 37 vs 66; 12 mo 42 vs 71 (P < 0.001)
NA Orozco et al, 201119 Pilot study (II) N = 10, mean age = 35 y, and M:F = 4:6 12 Autologous bone marrow cells, intradiscal 107 cells per disc ODI score
Baseline 25; 3 mo 13; 6 mo 9.4; 12 mo 7.4 (P < 0.0001)
Baseline 68.9; 3 mo 26.5; 6 mo 21.6; 12 mo 20 (P < 0.0001)
NA Noriega et al, 201621 RCT (I) N = 24, mean age = 38 y, and M:F = 17:7 12 Allogeneic mesenchymal bone marrow cells, Intradiscal 25 × 106 in 2 mL saline per disc ODI score, intervention vs control
Baseline 34 vs 24; 1 wk 27 vs 20; 3 mo 16 vs 25; 6 mo 20 vs 30; 12 mo 22 vs 34
Baseline 67 vs 62; 1 wk 63 vs 45; 3 mo 43 vs 46; 6 mo 40 vs 51; 12 mo 47 vs 47
Baseline (control vs intervention): Pfirrmann
3.15 ± 0.76 vs 3.68 ± 0.67
Results:
3.78 ± 0.82 vs 3.18 ± 0.87Kumar et al, 201720 Phase 1 clinical trial, open label, single arm (II) N = 10, mean age = 43.5 y, and M:F = 6:4 12 Adipose-derived MSC + HA, Intradiscal Low dose 2 × 107 cells/disc (n = 5); high dose 4 × 107 cells/disc (n = 5) ODI score
Baseline 42.8; 1 mo 31.2; 3 mo 31.7; 6 mo 21.3; 12 mo 16.8 (P = 0.002)
Baseline 65; 1 mo 46; 3 mo 43; 6 mo 32; 12 mo 29 (P = 0.002)
Baseline: Pfirrmann Grade IV = 10.
Result: No increase in Pfirrmann gradeAmirdelfan et al, 202022 RCT (I) N = 100 (6M 30/18M 30), age = 37.9–44.5 y, and M:F = 53:47 36 Allogeneic MPC +1% HA 1 mL (6 million and 18 million) control: saline and HA; Intradiscal Low dose: 6 × 106 MPC +1 mL 1% HA ODI score
Baseline 52.07; 1 mo 36.83; 3 mo 32.59; 6 mo 28.25; 12 mo 31.85; 24 mo 29.69; 36 mo 30.69 (P < 0.05)
Baseline 69.67; 1 mo 40.93; 3 mo 30.28; 6 mo 25.93; 12 mo 31.48; 24 mo 33; 36 mo 35.69 (P < 0.05)
Baseline (control
vs intervention):
Grade II (0 vs 4),
Grade III (12 vs 13),
Grade IV (19 vs 32),
Grade V (3 vs 4),
Grade VI (2 vs 3),
Grade VII (3 vs 3), and
Grade VIII (1 vs 1).
Results: No significant improvement in Pfirrmann scoreHigh dose: 18 × 106 MPC + 1 mL 1% HA ODI score
Baseline 50.67; 1 mo 37.33; 3 mo 32.89; 6 mo 31.7; 12 mo 29.59; 24 mo 28.75; 36 mo 24.95 (P < 0.05)
Baseline 71.47; 1 mo 40.97; 3 mo 35.26; 6 mo 34.6; 12 mo 32.37; 24 mo 37.63; 36 mo 28.24 (P < 0.05)
Abbreviations: BMC, bone marrow concentrate; CFU-F, colony forming unit-fibroblast; HA, hyaluronic acid; LBP, low back pain; M:F, male:female; MPC, mesenchymal precursor cell; MSC, mesenchymal stem cell; NA, not applicable or not available; NRS, numeric rating scale; ODI, Oswestry Disability Index; RCT, randomized controlled trial; SI, sacroiliac; VAS, visual analog scale.
Outcome Measure No of studies Mean Difference (95% CI) P I 2 (Heterogeneity) ODI 7 21.57 (19.47, 31.08) <0.00001 94% (high) VAS 7 38.97 (36.01, 41.93) <0.00001 94% (high) ODI after BMAC treatment 4 16.99 (12.65, 21.33) <0.00001 58% (moderate) VAS after BMAC treatment 4 36.06 (28.35, 43.76) <0.00001 76% (moderate) Pfirrmann improvement 2 0.44 (0.13, 0.75) 0.005 0% (low) Abbreviations: BMAC, bone marrow aspirate concentrate; ODI, Oswestry Disability Index; VAS, visual analog scale.
Note: Boldface indicates statistical significance.
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