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CLINICAL TRIAL WITH MESENCHYMAL STEM CELLS IN STROKE PATIENTS
EU CTIS ID: 2024-512514-18-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Comatose patients; patients with a score of 2 or more on item 1a of the NIHSS related to the degree of awareness.
- 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.
- Current drug or alcohol use or dependence.
- 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.
See the full eligibility criteria
Who can join
- 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
What rules you out
- Comatose patients; patients with a score of 2 or more on item 1a of the NIHSS related to the degree of awareness.
- 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.
- Current drug or alcohol use or dependence.
- 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.
- Patients who are participating in another clinical trial.
- Inability or unwillingness of the individual or their legal guardian/representative to provide written informed consent.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.