Table 2

Characteristics of included studies.

StudyStudy Design (Level of Evidence)Sample Size and DemographicFollow-Up, moType and Site of InsertionDose, Cells (mean CFU-F)Main ResultsRadiological Results
Lewandrowski et al, 202315 Retrospective observational cohort (II) N = 33, mean age = 47.6 y, and M:F = 18:1524Allogeneic polyclonal MSC, intradiscal5 × 106 allogeneic polyclonal MSC + 1% HAODI 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)

VAS score
  • 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)

1 patient experienced severe LBP for 1 d, but otherwise, no adverse treatment effects were mentioned in the study
Baseline: Pfirrmann grade (mean ± SD): 4.06 ± 0.72
Result: 3.65 ± 0.81
Wolff et al, 202016 Retrospective pilot study (II) N = 33, mean age = 45 y, and
M:F = 19:14
12BMC, Intradiscal3 mL, cells NAODI improvement from baseline
  • 2 wk 4.2%, 6–8 wk 26.7%; 3 mo 36.4%; 6 mo 55.6%; 12 mo 30.8%

NRS improvement from baseline
  • 2 wk 13.8%, 6–8 wk 45.8%; 3 mo 41.1%; 6 mo 23.5%; 12 mo 38.9%

No remarkable adverse event reported
NA
Pettine et al, 201717 Prospective, nonrandomized (II) N = 26, mean age = 40 y, and
M:F = 11:15
36Autologous BMC, Intradiscal2–3 mL, 121 × 106 per mL (2,713 per mL)ODI score
  • Baseline 56.7; 36 mo 17.5 (P < 0.001)

VAS score
  • Baseline 82.1; 36 mo 21.9 (P < 0.001)

No adverse events related to the study
Baseline:
Pfirrmann Grade IV = 4,
Grade V = 11,
Grade VI = 15, and
Grade VII = 10.
Result: 8 of 20 patients had improved Pfirrmann grade
Atluri et al, 202118 Open label, prospective controlled study (II) N = (40 intervention/40 control), mean age = 60 y, and M:F = NA12Autologous bone marrow MSC; intradiscal, intraepidural, facet joint, and SI joint2 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)

NRS score, intervention vs control
  • 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 = 4:612Autologous bone marrow cells, intradiscal107 cells per discODI score
  • Baseline 25; 3 mo 13; 6 mo 9.4; 12 mo 7.4 (P < 0.0001)

VAS score
  • 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 = 17:712Allogeneic mesenchymal bone marrow cells, Intradiscal25 × 106 in 2 mL saline per discODI 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

VAS score, intervention vs control
  • 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 ± 0.87
Kumar et al, 201720 Phase 1 clinical trial, open label, single arm (II) N = 10, mean age = 43.5 y, and M:F = 6:412Adipose-derived MSC + HA, IntradiscalLow 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)

VAS score
  • Baseline 65; 1 mo 46; 3 mo 43; 6 mo 32; 12 mo 29 (P = 0.002)

No adverse event during 1 y follow-up
Baseline: Pfirrmann Grade IV = 10.
Result: No increase in Pfirrmann grade
Amirdelfan et al, 202022 RCT (I) N = 100 (6M 30/18M 30), age = 37.9–44.5 y, and M:F = 53:4736Allogeneic MPC +1% HA 1 mL (6 million and 18 million) control: saline and HA; IntradiscalLow dose: 6 × 106 MPC +1 mL 1% HAODI 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)

VAS score
  • 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 score
High dose: 18 × 106 MPC + 1 mL 1% HAODI 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)

VAS score
  • 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.