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. 2023 Oct 24;24(21):15517. doi: 10.3390/ijms242115517

Table 4.

Clinical trials of stem cell therapy for detrusor underactivity.

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.