Phase IIa clinical trial, pilot, single centre, prospective, randomized, double-blind, placebo-controlled, with sequential inclusion of patients
20 Patients presenting with a moderate-severe acute ischemic stroke who will be randomized in a 1:1 proportion to intravenous treatment with allogeneic stem cells from adipose tissue or to placebo (vehicle).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
19
University Hospital La Paz
Madrid, Spain
Number of participants with Adverse events, complications.
To assess the safety of treatment with allogeneic stem cells from adipose tissue in acute ischemic stroke patients (Follow-up 24 months): * Adverse events (AES) reported spontaneously or in response to questions not addressed. Serious adverse events. These will be recorded in each visit during all the study period (24 months). * Neurological and systemic complications: deteriorating stroke, stroke recurrences, brain oedema, seizures, hemorrhagic transformation, respiratory infections, urinary tract infections, deep venous thrombosis, pulmonary embolism, gastrointestinal haemorrhage… These will be recorded in each visit during all the study period (24 months). * Development of tumours
Time frame: 24 months
Efficacy
To assess the potential efficacy of allogeneic stem cells from adipose tissue in acute ischemic stroke patients measured by the following parameters: 1. Outcome at three months evaluated by: modified Rankin Scale and the NIH Stroke Scale 2. total volume of stroke by performing MRI. To identify changes in biochemical markers of brain repair as VEGF, BDNF, MMP-9 and its relationship to neurological and functional outcomes.
Time frame: 3 months
Efficacy
To identify changes in biochemical markers of brain repair as VEGF, BDNF, MMP-9 and its relationship to neurological and functional outcomes.
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.