- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01678534
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 (AMASCIS-01)
February 27, 2018 updated by: Instituto de Investigación Hospital Universitario La Paz
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.(AMASCIS-01/2011)
Phase IIa clinical trial, pilot, single centre, prospective, randomized, double-blind, placebo-controlled, with sequential inclusion of patients
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Madrid, Spain, 28046
- University Hospital La Paz
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 consent (e.g. in cases of dysphasia, confusion, or reduced conscious level).
Exclusion criteria:
- Comatose patients. Patients with a score of 2 or more in the item 1a of the NIHSS related to the degree of awareness.
- 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.
- 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.
- Pre-existing dementia.
- Specify health status or any clinical conditions (e.g., life expectancy, co-existing disease) or other characteristics that precludes appropriate diagnosis, treatment or follow-up in the trial.
- Patients who are participating in another clinical trial.
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
In 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.
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Experimental: Allogeneic stem cells from adipose tissue
The 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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with Adverse events, complications.
Time Frame: 24 months
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To assess the safety of treatment with allogeneic stem cells from adipose tissue in acute ischemic stroke patients (Follow-up 24 months):
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24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy
Time Frame: 3 months
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To assess the potential efficacy of allogeneic stem cells from adipose tissue in acute ischemic stroke patients measured by the following parameters:
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3 months
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Efficacy
Time Frame: 3 months
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To identify changes in biochemical markers of brain repair as VEGF, BDNF, MMP-9 and its relationship to neurological and functional outcomes.
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3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2014
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
August 30, 2012
First Submitted That Met QC Criteria
August 31, 2012
First Posted (Estimate)
September 5, 2012
Study Record Updates
Last Update Posted (Actual)
February 28, 2018
Last Update Submitted That Met QC Criteria
February 27, 2018
Last Verified
December 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AMASCIS-01/2011
- 2011-003551-18 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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