Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02017912 | Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study of Autologous MSC-NTF Cells in Patients With ALS | PHASE2 | COMPLETED | 48 | — | — | May 1, 2014 | Jul 1, 2016 | Jun 6, 2024 | 3 | United States |
Safety assessed based on the incidence of treatment-emergent adverse events (TEAEs) (including serious adverse events \[SAEs\]) including clinically relevant changes in vital signs, clinical laboratory assessments, physical and neurological examinations, and electrocardiogram (ECG) tests, during transplantation of expanded autologous MSC-NTF cells administered on a single occasion via combined intrathecal (IT) administration and intramuscular (IM) injections
| Arm | Type | Description |
|---|---|---|
| Nurown MSC-NTF cells | ACTIVE_COMPARATOR | Single autologous MSC-NTF cells treatment by combined intramuscular and intrathecal administration |
| Excipient | PLACEBO_COMPARATOR | Combined intramuscular and intrathecal placebo administration |
| Name | Type | Description |
|---|---|---|
| Nurown MSC-NTF cells | BIOLOGICAL | Single autologous MSC-NTF cells treatment by combined intramuscular and intrathecal administration |
| Placebo | BIOLOGICAL | Excipient administration by combined intramuscular and intrathecal administration |
Inclusion Criteria 1. Males and females ages 18 to 75 years old, inclusive. 2. ALS diagnosed as possible, laboratory-supported probable, probable, or definite as defined by revised El Escorial criteria. 3. Disease onset, as defined by first reported occurrence of symptomatic weakness, spasticity, o...