<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01678534</url>
  </required_header>
  <id_info>
    <org_study_id>AMASCIS-01/2011</org_study_id>
    <secondary_id>2011-003551-18</secondary_id>
    <nct_id>NCT01678534</nct_id>
  </id_info>
  <brief_title>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</brief_title>
  <acronym>AMASCIS-01</acronym>
  <official_title>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)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto de Investigación Hospital Universitario La Paz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto de Investigación Hospital Universitario La Paz</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Phase IIa clinical trial, pilot, single centre, prospective, randomized, double-blind,&#xD;
      placebo-controlled, with sequential inclusion of patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      20 Patients presenting with a moderate-severe acute ischemic stroke who will be randomized in&#xD;
      a 1:1 proportion to intravenous treatment with allogeneic stem cells from adipose tissue or&#xD;
      to placebo (vehicle).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with Adverse events, complications.</measure>
    <time_frame>24 months</time_frame>
    <description>To assess the safety of treatment with allogeneic stem cells from adipose tissue in acute ischemic stroke patients (Follow-up 24 months):&#xD;
Adverse events (AES) reported spontaneously or in response to questions not addressed. Serious adverse events. These will be recorded in each visit during all the study period (24 months).&#xD;
Neurological and systemic complications: deteriorating stroke, stroke recurrences, brain oedema, seizures, hemorrhagic transformation, respiratory infections, urinary tract infections, deep venous thrombosis, pulmonary embolism, gastrointestinal haemorrhage… These will be recorded in each visit during all the study period (24 months).&#xD;
Development of tumours</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy</measure>
    <time_frame>3 months</time_frame>
    <description>To assess the potential efficacy of allogeneic stem cells from adipose tissue in acute ischemic stroke patients measured by the following parameters:&#xD;
Outcome at three months evaluated by: modified Rankin Scale and the NIH Stroke Scale&#xD;
total volume of stroke by performing MRI. To identify changes in biochemical markers of brain repair as VEGF, BDNF, MMP-9 and its relationship to neurological and functional outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy</measure>
    <time_frame>3 months</time_frame>
    <description>To identify changes in biochemical markers of brain repair as VEGF, BDNF, MMP-9 and its relationship to neurological and functional outcomes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Allogeneic stem cells from adipose tissue</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Allogenic mesenchymal stem cells from adipose tissue</intervention_name>
    <arm_group_label>Allogeneic stem cells from adipose tissue</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Male or female acute ischemic patients aged 60-80 years with symptoms of acute&#xD;
             cerebral infarction of less than 12h from stroke onset. If the time of symptom onset&#xD;
             is unknown, it shall refer to the last time the patient was asymptomatic seen.&#xD;
&#xD;
          -  Patients should be treated within two weeks from the onset of stroke symptoms.&#xD;
&#xD;
          -  Patients with a measurable focal neurological that must persist to the time of&#xD;
             treatment without clinically meaningful improvement.&#xD;
&#xD;
          -  Patients must have computerized tomography (CT) and / or magnetic resonance imaging&#xD;
             (MRI) compatible with the clinical diagnosis of acute ischemic stroke in the territory&#xD;
             of the middle cerebral artery before being included in the study.&#xD;
&#xD;
          -  Patients must have a score on the NIH Stroke Scale 8-20, with at least 2 of these&#xD;
             points in Sections 5 and 6 (motor deficit) at the time of inclusion.&#xD;
&#xD;
          -  Immediately (i.e. few minutes) before the stroke, patients should have a score on the&#xD;
             mRS ≤ 1 (no symptoms at all or no significant disability despite symptoms, able to&#xD;
             perform everyday tasks and activities).&#xD;
&#xD;
          -  Women of childbearing age should have a negative pregnancy test performed prior to&#xD;
             inclusion.&#xD;
&#xD;
          -  Obtaining informed consent signed (after a detailed explanation of the nature and&#xD;
             purpose of this study, the patient or guardian or legal representative must give their&#xD;
             consent to participate by signing the informed consent document). Assent from a&#xD;
             relative or career if the patient is unable to give meaningful consent (e.g. in cases&#xD;
             of dysphasia, confusion, or reduced conscious level).&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Comatose patients. Patients with a score of 2 or more in the item 1a of the NIHSS&#xD;
             related to the degree of awareness.&#xD;
&#xD;
          -  Evidence on neuroimaging (CT or MRI) of brain tumour, cerebral oedema with midline&#xD;
             shift and clinically significant compression of ventricles, cerebellar infarction or&#xD;
             brainstem, or intraventricular, intracerebral or subarachnoid haemorrhage.&#xD;
&#xD;
          -  Current drug or alcohol use or dependence that, in the opinion of the site&#xD;
             investigator, would interfere with adherence to study requirements.· Active infectious&#xD;
             disease, including HIV, hepatitis B, Hepatitis C, etc.&#xD;
&#xD;
          -  Pre-existing dementia.&#xD;
&#xD;
          -  Specify health status or any clinical conditions (e.g., life expectancy, co-existing&#xD;
             disease) or other characteristics that precludes appropriate diagnosis, treatment or&#xD;
             follow-up in the trial.&#xD;
&#xD;
          -  Patients who are participating in another clinical trial.&#xD;
&#xD;
          -  Inability or unwillingness of individual or legal guardian/representative to give&#xD;
             written informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <results_reference>
    <citation>Diez-Tejedor E, Gutierrez-Fernandez M, Martinez-Sanchez P, Rodriguez-Frutos B, Ruiz-Ares G, Lara ML, Gimeno BF. Reparative therapy for acute ischemic stroke with allogeneic mesenchymal stem cells from adipose tissue: a safety assessment: a phase II randomized, double-blind, placebo-controlled, single-center, pilot clinical trial. J Stroke Cerebrovasc Dis. 2014 Nov-Dec;23(10):2694-2700. doi: 10.1016/j.jstrokecerebrovasdis.2014.06.011. Epub 2014 Oct 7.</citation>
    <PMID>25304723</PMID>
  </results_reference>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>February 27, 2018</last_update_submitted>
  <last_update_submitted_qc>February 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cerebral infarction</keyword>
  <keyword>Cellular therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01678534
org study id: AMASCIS-01/2011
secondary id: 2011-003551-18
nct id: NCT01678534
lead sponsor: 
has dmc: Yes
Phase IIa clinical trial, pilot, single centre, prospective, randomized, double-blind,
      placebo-controlled, with sequential inclusion of patients
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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of participants with Adverse events, complications.
time frame: 24 months
description: To assess the safety of treatment with allogeneic stem cells from adipose tissue in acute ischemic stroke patients (Follow-up 24 months):
Adverse events (AES) reported spontaneously or in response to questions not addressed. Serious adverse events. These will be recorded in each visit during all the study period (24 months).
Neurological and systemic complications: deteriorating stroke, stroke recurrences, brain oedema, seizures, hemorrhagic transformation, respiratory infections, urinary tract infections, deep venous thrombosis, pulmonary embolism, gastrointestinal haemorrhage… These will be recorded in each visit during all the study period (24 months).
Development of tumours
measure: Efficacy
time frame: 3 months
description: To assess the potential efficacy of allogeneic stem cells from adipose tissue in acute ischemic stroke patients measured by the following parameters:
Outcome at three months evaluated by: modified Rankin Scale and the NIH Stroke Scale
total volume of stroke by performing MRI. To identify changes in biochemical markers of brain repair as VEGF, BDNF, MMP-9 and its relationship to neurological and functional outcomes.
measure: Efficacy
time frame: 3 months
description: To identify changes in biochemical markers of brain repair as VEGF, BDNF, MMP-9 and its relationship to neurological and functional outcomes.
arm group label: Placebo
arm group type: Placebo Comparator
description: 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.
arm group label: Allogeneic stem cells from adipose tissue
arm group type: Experimental
description: 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
intervention type: Drug
intervention name: Allogenic mesenchymal stem cells from adipose tissue
arm group label: Allogeneic stem cells from adipose tissue
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 60 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Spain
citation: Diez-Tejedor E, Gutierrez-Fernandez M, Martinez-Sanchez P, Rodriguez-Frutos B, Ruiz-Ares G, Lara ML, Gimeno BF. Reparative therapy for acute ischemic stroke with allogeneic mesenchymal stem cells from adipose tissue: a safety assessment: a phase II randomized, double-blind, placebo-controlled, single-center, pilot clinical trial. J Stroke Cerebrovasc Dis. 2014 Nov-Dec;23(10):2694-2700. doi: 10.1016/j.jstrokecerebrovasdis.2014.06.011. Epub 2014 Oct 7.
PMID: 25304723
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Cerebral Infarction
mesh term: Ischemia