CLINICAL TRIAL WITH MESENCHYMAL STEM CELLS IN STROKE PATIENTS
Key facts
- Where
- Madrid és Sevilla, SpanyolországSee the 2 sites
- Phase
- 2. fázis
Where in Spanyolország
- Hospital Universitario La PazMadrid, SpanyolországNo longer taking part
- University Hospital Virgen Del Rocio S.L.Sevilla, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
- Trial code
- EU 2024-512514-18-00
- Record updated
- 2024. április 3.
- Original description
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.Read full original descriptionShow less
AMASCIS-02. ALOGENIC ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS IN ISCHEMIC STROKE. A PHASE IIB MULTICENTER DOUBLE BLIND PLACEBO CONTROLLED CLINICAL TRIAL.
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.
Inclusion: Male and female acute ischemic patients aged more than 18 years; 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; 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); 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; A prestroke score on the Modified Rankin Scale (mRS) ≤1 (no significant disability); 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; 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; Signed informed consent.
Exclusion: Current drug or alcohol use or dependence; 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; Active infectious disease, including human immunodeficiency virus, hepatitis B, and hepatitis C. A controlled infection is not an exclusion criterion; Pre-existing dementia; 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; Comatose patients; patients with a score of 2 or more on item 1a of the NIHSS related to the degree of awareness; Patients who are participating in another clinical trial; Inability or unwillingness of the individual or their legal guardian/representative to provide written informed consent.