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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)

This study is currently recruiting participants.
Verified February 2017 by Instituto de Investigación Hospital Universitario La Paz
Sponsor:
ClinicalTrials.gov Identifier:
NCT01678534
First Posted: September 5, 2012
Last Update Posted: February 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz
  Purpose
Phase IIa clinical trial, pilot, single centre, prospective, randomized, double-blind, placebo-controlled, with sequential inclusion of patients

Condition Intervention Phase
Ischemic Stroke Drug: Allogenic mesenchymal stem cells from adipose tissue Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Further study details as provided by Instituto de Investigación Hospital Universitario La Paz:

Primary Outcome Measures:
  • Number of participants with Adverse events, complications. [ Time Frame: 24 months ]

    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


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 3 months ]

    To assess the potential efficacy of allogeneic stem cells from adipose tissue in acute ischemic stroke patients measured by the following parameters:

    1. Outcome at three months evaluated by: modified Rankin Scale and the NIH Stroke Scale
    2. 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.

  • Efficacy [ Time Frame: 3 months ]
    To identify changes in biochemical markers of brain repair as VEGF, BDNF, MMP-9 and its relationship to neurological and functional outcomes.


Estimated Enrollment: 20
Study Start Date: September 2014
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Placebo
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
Drug: Allogenic mesenchymal stem cells from adipose tissue

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678534


Locations
Spain
University Hospital La Paz Recruiting
Madrid, Spain, 28046
Contact: Exuperio Diez-Tejedor, MD,PhD    0034 917277444    ediez.hulp@salud.madrid.org   
Contact: Maria Yllescas, Pharmacist    0034 917277558    maria.yllescas@idipaz.es   
Principal Investigator: Exuperio Diez-Tejedor, MD, PhD         
Sponsors and Collaborators
Instituto de Investigación Hospital Universitario La Paz
  More Information

Publications:
Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT01678534     History of Changes
Other Study ID Numbers: AMASCIS-01/2011
2011-003551-18 ( EudraCT Number )
First Submitted: August 30, 2012
First Posted: September 5, 2012
Last Update Posted: February 15, 2017
Last Verified: February 2017

Keywords provided by Instituto de Investigación Hospital Universitario La Paz:
Cerebral infarction
Cellular therapy

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia