Table 2.
Overview of improvements in pain outcomes resulting from cell transplantation.
| Author | Ref | FU (y) |
Improved? | Improvement to baseline at max FU (Percentage change from baseline) |
Improvement compared to control groups (Percentage change from baseline) |
Type |
|---|---|---|---|---|---|---|
| Yoshikawa | [36] | 2 | ✔ | VAS scores improved (=28%) | n.a. | Mesenchymal stromal cells |
| Orozco | [37] | 1 | ✔ | Significant 49mm VAS lumbar pain reduction (=71%) Significant 32mm VAS sciatic pain reduction (=85%) |
n.a. | |
| Centeno | [38,39] | 6 | ✔ | Significant 1.9 NPS reduction (=37%) Average reported SANE-rating was 53 |
n.a. | |
| Noriega | [40], [41], [42] | 3.5 | ✔ | Significant reduction in VAS scores |
Cell-treated resulted in significant improvement, while control did not, with trend of stronger pain reduction | |
| [41] | 1 | ✔ | Significant 20mm VAS reduction (=30%) | Trend of slightly enhanced pain reduction (Placebo: 15mm [=24%]) | ||
| Papadimitriou | [43,44] | 2 | ✔ | 2.8 point NRS back pain reduction (=38%) 2.3 point NRS leg pain reduction (=47%) |
n.a. | |
| Amirdelfan § | [45,46] | 3 | Significant 32mm VAS pain reduction low dose (=46%) Significant 42mm VAS pain reduction high dose (=59%) MIC (≥30%): low dose was 53% and high dose was 57% CSC (≥50%): low dose was 43% and high dose was 50% |
High dose had significant higher VAS reduction than placebo (=24%), but not carrier group (=42%) High dose significant higher MIC (≥30%) and CSC (≥50%) rates than placebo (20%), but not carrier (45% & 35%) |
||
| Jung | [47] | <0.5 | n.a. | - | - | |
| Piccirilli | [48] | 1 | n.a. | - | - | |
| Kumar | [49] | 1 | ✔ | Significant 3.6cm VAS back pain reduction (=55%) 6 pts showed ≥50% VAS improvement |
n.a. | |
| Bates | [50] | 1 | ✔ | 56% of pts reported ≥50% NPRS pain improvement 78% of pts report general NPRS improvement Second injection improved by 40% and worsened for 40% of pts |
n.a. | |
| Zhang | [51] | 2 | n.a. | - | - | |
| Pang | [52] | 2 | ✔ | 5cm VAS reduction (=66%) | n.a. | |
| Meisel | [53], [54], [55] | 2 | ✔ | 8mm VAS improvement (=42%)† 5 point QBPD improvement (=37%)† |
Trend of enhanced outcomes in QBPD and VAS scores compared to discetomy-only group | Chondrogenic cells |
| Mochida | [56] | 3 | ✔ | 1.5 JOA-LBPsubscale improvement (=56%) | n.a. | |
| Tschugg | [57,58] | <0.5 | ? | - | - | |
| Schwan | [59] | n.a. | ? | - | - | |
| Beall | [60] | 1 | ✔ | 43mm VAS improvement (=78%) | Trend of enhanced VAS improvement compared to placebo control Clear trend of enhanced VAS improvement to conservative treatment before crossover |
|
| Hunter | [61,62] | 1 | ✔ | 35mm VAS improvement (=54%) 63% of pts reported ≥50% VAS improvement 67% of pts reported ≥20 mm improvement (Crossover: 70% and 91% respectively) |
31mm VAS reduction for placebo Trend higher portion of ≥50% VAS and ≥20mm change than placebo (53% and 57% respectively) |
|
| Foley | [63] | 1.5 | ✔ | Significant 40mm VAS change for high dose (=59%) compared to MCID Trend of VAS improvement both doses |
Trend of enhanced outcomes for high dose group compared to control groups | |
| Xuan | [64] | 6 | ✔ | Significant 6.3cm VAS improvement (=88%) | Significant enhanced improvement compared to discetomy-only cohort | |
| Coric | [65] | 1 | ✔ | Significant 2.6 point NRS improvement (=46%) | n.a. | |
| Comella | [66] | 0.5 | ✔ | Significant 2.0cm VAS improvement (=36%) Significant 0.8 PPI improvement (=31%) Slight trend improvement in Dallas Pain Questionnaire |
n.a. | Mixture of cells |
| Pettine | [68,69] | 3‡ | ✔ | Significant 60mm VAS decrease (=73%) | n.a. | |
| [67] | 1 | ✔ | Significant 46mm VAS improvement (=58%) | n.a. | ||
| Wolff | [70] | 1 | ✔ | 39% of pts reported ≥50% NRS improvement | n.a. | |
| Ramos | [71] | 1 | n.a. | - | - | |
| El-Kadiry | [72] | 1 | ✔ | Significant 3.8cm VAS improvement (=63%) 17.2 BPI improvement (=35%) |
n.a. | |
| Jerome | [73] | <0.5 | n.a. | - | - | |
| Xu | [74] | 2 | ✔ | Significant 5.9cm VAS reduction(=80%) | Significant higher reduction in VAS than discectomy-only or discetomy with AF-suture | |
| Subach | [75] | 1 | n.a. | - | - | |
| Haufe | [76] | 1 | ✘ | No pain improvement was observed | n.a. |
✔: improvement reported, ✘: no improvement reported, ?: unreported or unclear results, * Cells were transplanted intradiscally, but complemented with platelet lysate injection at other sites, † Change is observed after microdiscectomy, ‡ Only includes 20/26 patients that did not progress to surgery, § values based on PTI corrected data. Abbreviations: AF – Annulus fibrosis, BPI – Back pain index, CSC – Clinically significant change, FU – (maximal) Follow up, JOA – Japanese Orthopedic Association, LBP – Low back pain, MCID – Minimally clinical important differences, MIC – Minimally important change, N.A. – Not applicable, NPS – Numeric pain scale, NPRS - Numeric pain rating scale, NRS – Numerical rating scale, PPI – Present pain index, pts – patients, QBPD - Quebec Back-Pain Disability Scale, REF – Reference, and VAS – Visual analog scale.