Allogeneic Adipose Tissue-derived Mesenchymal Stem Cells in Ischemic Stroke

• Status: Recruiting
• Trial end date: 2023-07-15
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, doble blind, placebo controlled clinical trial to asses de safety and efficacy of intravenous administration of alogenic adipose tissue-derived mesenchymal stem cells in the first four days from acute ischemic stroke.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Ischemic stroke patients > 18 years old

• Patients must be able to be treated within the first 4 days (+/- 1) from acute stroke symptoms onset. 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. NIHSS evaluation for screening of these patients will take place after finalization of reperfusion therapies (if they have been performed) providing that the clinical condition of the patient is stable with no prevision of immediate recovery. A measurable focal neurologic disabilty must persist to the time of treatment.

• A prestroke score on the Modified Rankin Scale (mRS) ≤1 (no significant disability).

• 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:

Have undergone a documented hysterectomy and/or bilateral oophorectomy; Have medically confirmed ovarian failure; or Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause.

• 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.

• Signed informed consent

Exclusion Criteria:

• 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 brain tumour, cerebral oedema with midline shift and a clinically significant compression of ventricles, cerebellar or brainstem infarction and intraventricular, intracerebral or subarachnoid haemorrhage. Small petechial 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.