Completed
AMASCIS-01Reparative 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.(AMASCIS-01/2011)
What is being tested
Placebo
+ Allogenic mesenchymal stem cells from adipose tissue
Drug
Who is being recruted
Brain Diseases+13
+ Cardiovascular Diseases
+ Central Nervous System Diseases
From 60 to 80 Years
+15 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 2
Interventional
Study Start: September 2014
Summary
Principal SponsorInstituto de Investigación Hospital Universitario La Paz
Last updated: February 28, 2018
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2014
Actual date on which the first participant was enrolled.20 Patients presenting with a moderate-severe acute ischemic stroke who will be randomized in a 1:1 proportion to intravenous treatment with allogeneic stem cells from adipose tissue or to placebo (vehicle).
Principal SponsorInstituto de Investigación Hospital Universitario La Paz
Last updated: February 28, 2018
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
19 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 60 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Brain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesBrain IschemiaCerebrovascular DisordersInfarctionIschemiaNecrosisNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesBrain InfarctionStrokeIschemic StrokeCerebral Infarction
Criteria
8 inclusion criteria required to participate
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)
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
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 consent (e.g. in cases of dysphasia, confusion, or reduced conscious level)
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
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7 exclusion criteria prevent from participating
Comatose patients. Patients with a score of 2 or more in the item 1a of the NIHSS related to the degree of awareness
Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. Active infectious disease, including HIV, hepatitis B, Hepatitis C, etc
Evidence on neuroimaging (CT or MRI) of brain tumour, cerebral oedema with midline shift and clinically significant compression of ventricles, cerebellar infarction or brainstem, or intraventricular, intracerebral or subarachnoid haemorrhage
Inability or unwillingness of individual or legal guardian/representative to give written informed consent
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboIn patients randomly assigned to the placebo arm will receive a intravenous solution (containing the vehicle) with the same appearance as the drug under investigation.
It will be administered as a single intravenous dose within the first two weeks after the onset of stroke symptoms.
Group II
ExperimentalThe experimental drug is a solution of mesenchymal stem cells from adipose tissue. It will be administered as a single intravenous dose within the first two weeks after the onset of stroke symptoms.Dose: 1 million units/kg
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center