Reparative Therapy in Acute Ischemic Stroke With Allogenic Mesenchymal Stem Cells From Adipose Ti… (NCT01678534) | Clinical Trial Compass
CompletedPhase 2
Reparative Therapy in Acute Ischemic Stroke With Allogenic Mesenchymal Stem Cells From Adipose Tissue, Safety Assessment, a Randomised, Double Blind Placebo Controlled Single Center Pilot Clinical Trial
Spain19 participantsStarted 2014-09
Plain-language summary
Phase IIa clinical trial, pilot, single centre, prospective, randomized, double-blind, placebo-controlled, with sequential inclusion of patients
Who can participate
Age range60 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Male or female acute ischemic patients aged 60-80 years with symptoms of acute cerebral infarction of less than 12h from stroke onset. If the time of symptom onset is unknown, it shall refer to the last time the patient was asymptomatic seen.
* Patients should be treated within two weeks from the onset of stroke symptoms.
* Patients with a measurable focal neurological that must persist to the time of treatment without clinically meaningful improvement.
* Patients must have computerized tomography (CT) and / or magnetic resonance imaging (MRI) compatible with the clinical diagnosis of acute ischemic stroke in the territory of the middle cerebral artery before being included in the study.
* Patients must have a score on the NIH Stroke Scale 8-20, with at least 2 of these points in Sections 5 and 6 (motor deficit) at the time of inclusion.
* Immediately (i.e. few minutes) before the stroke, patients should have a score on the mRS ≤ 1 (no symptoms at all or no significant disability despite symptoms, able to perform everyday tasks and activities).
* Women of childbearing age should have a negative pregnancy test performed prior to inclusion.
* Obtaining informed consent signed (after a detailed explanation of the nature and purpose of this study, the patient or guardian or legal representative must give their consent to participate by signing the informed consent document). Assent from a relative or career if the patient is unable to give meaningful consen…
What they're measuring
1
Number of participants with Adverse events, complications.
Timeframe: 24 months
Trial details
NCT IDNCT01678534
SponsorInstituto de Investigación Hospital Universitario La Paz