Table 5.
Summary of Safety Outcomes.
| Outcome | Study (Design) | Intervention vs Comparator (if Applicable), Effect Size (95% CI)a |
|---|---|---|
| Allogenic | ||
| Serious adverse events | Noriega, 2017 (RCT) | MSC (n = 12): 0% vs sham (n = 12): 0% |
| Coric, 2013 (CS) | Chondrocytes (N = 15): 0% | |
| Pain requiring opioids | Noriega, 2017 (RCT) | MSC (n = 12): 8.3% (1/12) vs sham (n = 12): 8.3% (1/12) |
| Minor pain (NSAID use) | MSC (n = 12): 25% (1/12) vs sham (n = 12): 66.6%(8/12) | |
| Progression to surgery | Coric, 2013 (CS) | Chondrocytes (N = 15): 20% (3/15) |
| Autologous stem cells | ||
| Any complaint | MSC: Centeno, 2017 (CS) | 27% (9/33) |
| Nonserious treatment-related AE | Pain-relatedb: 9.0% (3/33) Other: 3% (1/33) |
|
| Second injection | MSC: Pettine, 2015 (CS) | 6 months: 7.7% (2/26) |
| Subsequent surgery | MSC: Centeno, 2017 (CS) | 6.0% (2/33) |
| MSC: Pettine, 2015 (CS) | 12 months: 7.7% (2/26) | |
| 24 months: 19.2% (5/26) | ||
| 36 months: 23.1% (6/26) | ||
| Hematopoietic: Haufe, 2006 (CS) | Fusion: 70% (7/10), TDR: 10%(1/10) | |
| Autologous chondrocytes | ||
| Any AE (mild or moderate intensity)c | Tschugg, 2016 (RCT) |
Novocart Disc Basic vs Novocart Disc
Plus 50% (6/12) vs 25% (2/8); RR 2.0 (0.5, 7.5) |
| Treatment-related AEd | 8.3% (1/12) vs 12/5% (1/8); RR 0.6 (0.06, 9.2) |
Abbreviations: AE, adverse event; CS, case series; HA, hyaluronic acid; MSC, mesenchymal stem cells; N/A, not applicable; NR, not reported; NSAID, nonsteroidal anti-inflammatory drug; RCT, randomized controlled trial; TDR, total disc replacement.
aEffects sizes included, when applicable, and calculated by Aggregate Analytics, Inc. (AAI).
bAll events resolved; authors report an additional AE (large herniated nucleus pulposus occurring months following injection; unclear if procedure related or progression of degenerative process).
cNasopharyngitis most common in the Novocart Disc (ND) plus group (n = 3); not associated with sequestrectomy or implantation; additional AEs not described.
dEvents determined by investigator to be related to sequestrectomy and study treatment; including 1 patient with intervertebral disc protrusion (ND Plus group) and 1 patient with spinal pain after implant (ND Basic group).