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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02290886 | A Multicenter Phase I/II Clinical Trial to Evaluate Safety of Mesenchymal Stem Cell in Patients With Amyotrophic Sclerosis Lateral | PHASE1 | COMPLETED | 52 | — | — | Jul 1, 2014 | Mar 2, 2022 | Apr 6, 2022 | 4 | Spain |
To evaluate the safety of the intravenous administration of 3 doses of autologous mesenchymal stem cells (MSC) from adipose tissue in patients with Amyotrophic lateral Sclerosis (ALS) ABSENCE of: complications in the place of the infusion, appearance of a new neurological effect not attributable to the natural progression of this pathology and adverse serious unexpected reactions or not, attributable to the treatment (SUSSARs or SAE)
To evaluate the safety of the intravenous administration of 3 doses of autologous
To evaluate the safety of the intravenous administration of 3 doses of autologous
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Intravenous administration of placebo |
| 1 million of MSC | EXPERIMENTAL | Intravenous administration of 1 million of MSC/ kg |
| 2 million of MSC | EXPERIMENTAL | Intravenous administration of 2 million of MSC/ kg |
| 4 million of MSC | EXPERIMENTAL | Intravenous administration of 4 million of MSC/ kg |
| Name | Type | Description |
|---|---|---|
| Intravenous administration of placebo | OTHER | - |
| Intravenous administration of 1 million of MSC | DRUG | - |
| Intravenous administration of 2 million of MSC | DRUG | - |
| Intravenous administration of 4 million of MSC | DRUG | - |
Inclusion Criteria: 1. Women and males over 18-year-old. 2. Good understanding of the protocol and aptitude to grant the informed assent. 3. Diagnosis of sporadic ALS, with diagnosis of certainty, that is to say, definite or probable, in agreement with the criteria of "El Escorial", of the World Fe...