ALLOGENEIC ADIPOSE-DERIVED MESENCHYMAL STEM CELLS EXPANDED for Ischemic stroke|Acute ischemic stroke

Inclusion criteria

• {"criterion_text":"- Male and female acute ischemic patients aged more than 18 years\n- 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.\n- 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).\n- 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.\n- A prestroke score on the Modified Rankin Scale (mRS) ≤1 (no significant disability).\n- Female subjects of non-child bearing potential. Female subjects who are of nonchildbearing potential are defined as meeting at least 1 of the following criteria: o Have undergone a documented hysterectomy and/or bilateral oophorectomy or bilateral salpingectomy; o Have medically confirmed ovarian failure; or o Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.\n- Female subjects of child-bearing potential need a confirmed recent menstrual period and negative pregnancy test; and must agree to use adequate contraception for the duration of the study (from screening through the end of study at 24 months since it´s inception). Given human data on pregnancies is not available, the following types of contraception are considered adequate provided they are locally authorized for use: intrauterine contraceptive device, bilateral tubal occlusion, vasectomized partner or sexual abstinence.. Hormonal contraceptive methods, though highly effective, cannot be recommended given their augmented risk of stroke.\n- Signed informed consent"}

Exclusion criteria

• {"criterion_text":"- Comatose patients; patients with a score of 2 or more on item 1a of the NIHSS related to the degree of awareness.\n- 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.\n- Current drug or alcohol use or dependence.\n- Active infectious disease, including human immunodeficiency virus, hepatitis B, and hepatitis C. A controlled infection is not an exclusion criterion.\n- Pre-existing dementia.\n- 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.\n- Patients who are participating in another clinical trial.\n- Inability or unwillingness of the individual or their legal guardian/representative to provide written informed consent."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Safety assessed by recording adverse events (AEs) and serious adverse events (SAEs), and monitoring specified neurological and systemic complications (deteriorating stroke, recurrences, brain oedema, seizures, haemorrhagic transformation, respiratory and urinary infections, deep venous thrombosis, pulmonary embolism)."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"mRS measured at months 3, 6, 12 and 24; success defined as mRS 0-3, failure 4-6; additional mRS shift analysis at same timepoints."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"NIHSS assessed at all scheduled visits; success = ≥75% improvement from baseline; exploratory analyses include median (IQR) distribution and frequency of NIHSS ≤1 between groups."}
• {"endpoint_text":"- Biochemical markers. They will be measured at baseline, day 7 and month 3.","definition_or_measurement_approach":"Biochemical markers measured at baseline, Day 7 and Month 3; specific markers not listed."}

Spain

Earliest CTIS Part Ii Submission Date

20-03-2024

Latest Decision Or Authorization Date

03-04-2024

Processing Time Days

14

Number Of Sites

2

Number Of Participants

30

Primary sponsor

Full Name

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz

Organisation Type

Patient organisation/association

Country Of Registered Address

Spain