ISCHEMIC STROKE
Conditions
Brief summary
The safety of mesenchymal stem cells from adipose tissue will be assessed using the following parameters: Adverse events (AES) reported spontaneously or in response to questions not addressed. Serious adverse events. Neurological and systemic complications: deteriorating stroke, stroke recurrences, brain oedema, seizures, haemorrhagic transformation, respiratory infections, urinary tract infections, deep venous thrombosis and pulmonary embolism.
Detailed description
Modified Rankin Scale (mRS): success is considered positive when the patient obtains a score of 0-3, and failure scores of 4 to 6 at months 3, 6, 12 and 24. Additional exploratory efficacy analysis: mRS shift at months 3, 6, 12 and 24., NIH Stroke Scale: It will be measured at all the scheduled visits. Success is considered positive when the patient obtains an improvement of 75% or more from baseline. Additional exploratory efficacy analysis: differences in the distribution of median (IQR) and in the frequency of NIHSS ≤1 between groups., Biochemical markers. They will be measured at baseline, day 7 and month 3.
Interventions
DRUGAllogenic adipose-derived mesenchymal stem cells expanded
Sponsors
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety of mesenchymal stem cells from adipose tissue will be assessed using the following parameters: Adverse events (AES) reported spontaneously or in response to questions not addressed. Serious adverse events. Neurological and systemic complications: deteriorating stroke, stroke recurrences, brain oedema, seizures, haemorrhagic transformation, respiratory infections, urinary tract infections, deep venous thrombosis and pulmonary embolism. | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Rankin Scale (mRS): success is considered positive when the patient obtains a score of 0-3, and failure scores of 4 to 6 at months 3, 6, 12 and 24. Additional exploratory efficacy analysis: mRS shift at months 3, 6, 12 and 24., NIH Stroke Scale: It will be measured at all the scheduled visits. Success is considered positive when the patient obtains an improvement of 75% or more from baseline. Additional exploratory efficacy analysis: differences in the distribution of median (IQR) and in the frequency of NIHSS ≤1 between groups., Biochemical markers. They will be measured at baseline, day 7 and month 3. | — |
Countries
Spain
Outcome results
None listed