Moderate-severe ischemic stroke MedDRA version: 22.1 Level: LLT Classification code 10055221 Term: Ischemic stroke System Organ Class: 100000004852
Conditions
Interventions
Product Name: Allogeneic Adipose - derived stem cells
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Mesenchymal Stem Cells
Other descriptive name: MESENCHYMAL STEM CELLS (M
Sponsors
Fundación para la Investigación Biomédica del Hospital Universitario de La Paz (FIBHULP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female acute ischemic patients aged more than 18 years 2. Patients should be treated within 4 days (+/-1 days) from the onset of stroke symptoms. If the time of symptom onset is unknown, this shall refer to the last time the patient was observed as asymptomatic. 3. A computed tomography (CT) or magnetic resonance imaging (MRI) scan compatible with the clinical diagnosis of acute non-lacunar IS in the region of the middle cerebral artery (with cortical or subcortical involvement). 4 .A score on the National Institute of Health Stroke Scale (NIHSS) of 8-20, with at least two of these points in sections 5 and 6 (motor deficit) at the time of inclusion and in which a measurable focal neurologic deficit persists to the time of treatment. 5. A prestroke score on the Modified Rankin Scale (mRS) =1 (no significant disability). 6. Female subjects non-child bearing potential. Female subjects who are of non-childbearing potential are defined as meeting at least 1 of the following criteria: a)Have undergone a documented hysterectomy and/or bilateral oophorectomy; b)Have medically confirmed ovarian failure; or c)Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause. 7. Female subjects of child-bearing potential need a negative pregnancy test and must agree to use adequate contraception for the duration of the study (from screening through the final of the study). The following types of contraception are considered adequate provided they are locally authorized for use: oral, transdermal, or injectable (depot) estrogen and/or progestogen, selective estrogen receptor modulator therapy, intrauterine contraceptive device, double barrier method (e.g., condom and diaphragm or spermicidal gel) or vasectomy. 8. Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Comatose patients; patients with a score of 2 or more on item 1a of the NIHSS related to the degree of awareness. 2. Evidence on neuroimaging of a brain tumor, cerebral edema with midline shift and a clinically significant compression of ventricles, cerebellar or brainstem infarction, and intraventricular, intracerebral, or subarachnoid hemorrhage. Petechial small haemorrhages are not exclusion criteria. 3. Current drug or alcohol use or dependence. 4. Active infectious disease, including human immunodeficiency virus, hepatitis B, and hepatitis C. A controlled infection is not an exclusion criterion. 5. Pre-existing dementia. 6. A health status, any clinical condition (eg, short life expectancy, and coexisting disease or a surgical or endovascular planned procedure) or other characteristic that precludes appropriate diagnosis, treatment, or follow-up in the trial. 7. Patients who are participating in another clinical trial. 8. Inability or unwillingness of the individual or their legal guardian/representative to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety of the intravenous administration of allogeneic stem cells from adipose tissue within the first 4 days from stroke onset in acute ischemic stroke patients.;Secondary Objective: To assess the potential efficacy of allogeneic stem cells from adipose tissue when administered within the first 4 days from stroke onset in acute ischemic stroke patients.;Timepoint(s) of evaluation of this end point: Safety evaluations will be performed at every scheduled visit during the study duration: V1 (screening), V2 (baseline), V3 (2h), V4 (24h), V5 (7 days or hospital discharge), V6 (3m), V7 (6m), V8 (12m), V9 (18m), V10 (24m).;Primary end point(s): 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. These will be recorded in each visit during all the study period. - Neurological and systemic complications: deteriorating stroke, stroke recurrences, brain oedema, seizures, hemorrhagic transformation, respiratory infections, urinary tract infections, deep venous thrombosis, and pulmonary embolism. These will be recorded in each visit during all the study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. 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. 2.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. 3. Biomarkers. Granulocyte-macrophage colony-stimulating factor (GM-CSF), Platelet-derived growth factor BB (PDGF-BB), Brain-derived neurotrophic factor (BDNF), Vascular endothelial growth factor (VEGF), Transforming growth factor 1 (TGF-1), Endostatin, Glial fibrillary acid protein (GFAP), Myelin basic protein (MBP), Matrix Metalloproteinase 3 (MMP-3) and extracelular vesicles.;Timepoint(s) of evaluation of this end point: Modified Rankin Scale (mRS) and mRS shift: screening and months 3, 6, 12 and 24. NIH Stroke Scale: all scheduled visits Biomarkers: They will be measured at baseline, day 7 and month 3. | — |
Countries
Spain
Contacts
Public ContactUCICEC
Fundación para la Investigación Biomédica del Hospital Universitario de La Paz (FIBHULP)
Outcome results
None listed