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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01051882 | Autologous Cultured Mesenchymal Bone Marrow Stromal Cells Secreting Neurotrophic Factors (MSC-NTF), in ALS Patients. | PHASE1 | COMPLETED | 12 | — | — | Jun 1, 2011 | Mar 1, 2013 | Jan 10, 2019 | 1 | Israel |
Safety evaluation and tolerability of a single treatment administration of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF) by multiple intramuscular injections (IM) at 24 separate sites on the biceps and triceps muscles to patients with ALS at the early disease stage
Safety evaluation and tolerability of single intrathecal injection (IT) into the cerebrospinal fluid (CSF) of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF),to patients with ALS at the progressive disease stage.
| Arm | Type | Description |
|---|---|---|
| MSC-NTF cells IM | EXPERIMENTAL | Intramuscular administration in early stage patients |
| MSC-NTF cells IT | EXPERIMENTAL | Intrathecal administration in progressive stage patients |
| Name | Type | Description |
|---|---|---|
| MSC-NTF cells transplantation (IM) | BIOLOGICAL | In early ALS subjects: Autologous MSC-NTF cells will be transplanted under mild anesthesia, intramuscularly into patients' clinically unaffected (or only mildly affected) upper arm biceps and triceps muscles according to a pre-designed grid. Intramuscular injections will be by a 26 gauge needle to a 1.5cm depth (ensuring that injection is into muscle and not adipose tissue). The patients will be injected at 24 sites with a total of 24 million cells |
| MSC-NTF cells transplantation (IT) | BIOLOGICAL | In progressive ALS subjects: Autologous MSC-NTF cells will be transplanted under mild anesthesia intrathecally(via a standard lumbar puncture)with a total of 60 million cells. |
Inclusion Criteria: 1. El Escorial criteria for definite or probable ALS 2. Either men or non pregnant women between 20-75 years of age. 3. Patient is mentally intact and psychologically stable 4. For early stage ALS- Patients will be with ALS-FRS-R scale of at least 30 and disease duration of less...