Table 4.
Author (Year) | Treatment | Size (n) | Age (y) | Treatment Method | Safety | Efficacy (Intervention vs. Placebo) |
---|---|---|---|---|---|---|
Levanovich et al. (2015) [154] |
AMDC | 1 | 79 | Injections of a total of 250 million AMDC in a total volume of 15 mL distributed throughout approximately 30 sites. | No treatment-related adverse events or side effects were reported | 3 m after injection: first desire 711 to 365 mL; strong desire 823 to 450 mL; MCC: 844 to 663 mL. Using PGI-I questionnaire the patient reported “a little bit better”, while using GRA reported “moderate improvement” of UAB symptoms at 6 and 12 months. |
Gilleran et al. (2021) [155] |
AMDC | 20 | 64.3 ±11.6 | Injections of a total of 125 million AMDC in a total volume of 15 mL distributed throughout approximately 30 sites. | Minor AEs such as UTI, which resolved spontaneously without sequelae. | Patient-reported GRA: 3 m: 30% improved; 70% no change. 6 m: 50% improved; 45% no change; 5% worse. 12 m: 58% improved; 21% no change; 21% undetermined. PVR was trending downward while VE was trending upward. |
Coelho et al. (2023) [156] |
AMSC | 1 | 54 | 2 × 106 AMSCs were injected in the bladder trigone 60 days after fat collection, and a second injection was performed 30 days later. | No complications reported. | 60 days after last transplant vs. before: Residual volume: 20 mL vs. 800 mL; Maximum Flow: 23 mL/s vs. 2 mL/s; max Pdet: 46 cmH2O vs. 21 cmH2O; BCI: 161 vs. 31; ICIQ-SF: 1 vs. 19. |
Coelho et al. (2023) [157] |
AMSC | 9 | 65.66 ± 2.49 | 2 × 106 AMSCs were injected in the bladder trigone 60 days after fat collection, and a second injection was performed 30 days later. | 4 ecchymosis, 1 edema, 3 pains, 2 UTI, 1 hematuria, 1 dysuria |
60 days after last transplant vs. before: Residual volume: 118.33 ± 85.51 mL vs. 420.00 ± 191.41 mL; p < 0.05 Maximum Flow: 11.56 ± 1.67 mL/s vs. 7.78 ± 0.76 mL/s; p < 0.05 max Pdet: 41.56 ± 5.75 cmH2O vs. 20.22 ± 8.29 cmH2O; p < 0.05 BCI: 100.56 ± 8.89 vs. 44.33 ± 4.85; p < 0.05 ICIQ-SF: 3.78 ± 0.78 vs. 11.44 ± 1.43; p < 0.05. |
AMDC: autologous muscle derived cell; PGI-I: patient global impression of improvement; GRA: global response assessment; AE: adverse effects; UTI: urinary tract infection; GRA: global response assessment; PVR: post-void residual; VE: voiding efficiency. AMSC: autologous mesenchymal stromal cells; max Pdet: maximum detrusion pressure; BCI = Pdet@Qmax + 5Qmax. ICIQ-SF: International Continence on Incontinence Questionnaire-Short Form.