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Alogenic Adipose Tissue-derived Mesenchymal Stem Cells in Ischemic Stroke (AMASCIS-02)

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ClinicalTrials.gov Identifier: NCT04280003
Recruitment Status : Not yet recruiting
First Posted : February 21, 2020
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz

Brief Summary:
This is a multicenter, doble blind, placebo controlled clinical trial to asses de safety and efficacy of intravenous administration of alogenic adipose tissue-derived mesenchymal stem cells in the first four days from acute ischemic stroke.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Adipose Tissue-derived Stem Cell Functional Status Other: Alogenic adipose tissue-derived stem cells Drug: Placebo solution Phase 2

Detailed Description:
Two spanish hospitals with teams experienced in stroke management will participate in this study, recruiting a total of 30 patients between them both. After confirming that patients fulfill the inclusion criteria and none of the exclusion criteria, informed consent will be signed and randomization will take place (1:1). There are two different groups of treatment; the first group will be treated with intravenous alogenic adipose tissue-derived stem cells (at a concentration of one million cells per kg) within the first four days from stroke onset, the second group will be treated will an intravenous placebo solution. Follow-up will last for 24 months during which safety issues such as adverse events and neurological and systemic complications will be assessed at 24 hours, 7 days and 3, 6, 12,18 and 24 months after treatment. Neurological disability using the modified Rankin Scale and National Institute of Health Stroke Scale will also be registered in every scheduled visit. Biochemical markers of tissue repair (GM-CSF, BDNF, VEGF, TGF-1, GFAP, MBP, MMP-3) as well as extracellular vesicles will be extracted on baseline visit as well as 7 days and 3 months after treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two different treatment grupos; intravenous alogenic adipose tissue-derived mesenchymal stem cells or intravenous placebo solution
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Treatment and placebo solutions have identical appearance. Protocols will be designed to ensure that the physician evaluating patient safety and efficacy outcome as well as laboratory analysis, will not have access to the randomisation codes.
Primary Purpose: Treatment
Official Title: Alogenic Adipose Tissue-derived Mesenchymal Stem Cells in Ischemic Stroke. A Phase IIB Multicenter Double Blind Placebo Controlled Clinical Trial
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : May 1, 2023

Arm Intervention/treatment
Experimental: Treatment group
15 patients will receive intravenous alogenic adipose tissue-derived stem cells in a single dose of one million cells per kg.
Other: Alogenic adipose tissue-derived stem cells
Concentration of the cells: 10 million cells / ml

Placebo Comparator: Placebo group
15 patients will receive a single intravenous placebo solution with the same appearance as the treatment group.
Drug: Placebo solution
Placebo intravenous solution, same appearance stem cells solution




Primary Outcome Measures :
  1. Safety of administration of adipose tissue-derived mesenchymal stem cells measured as reported adverse events [ Time Frame: Up to 24 months after treatment or placebo administration ]
    Adverse events reported spontaneously or in response to questions not addressed.

  2. Safety of administration of adipose tissue-derived mesenchymal stem cells measured as neurological o systemic complications [ Time Frame: Up to 24 months after treatment or placebo administration ]
    Neurological or systemic complications


Secondary Outcome Measures :
  1. Efficacy of administration of adipose tissue-derived mesenchymal stem cells measured by the Modified Rankin Scale [ Time Frame: Up to 24 months after treatment or placebo administration ]
    Modified Rankin Scale (mRS): success is considered when the patient obtains a score of 0-3, and failure include scores of 4 to 6 at months 3,6,12 and 24. An additional exploratorry efficacy analysis of mRS shift at months 3,6,12 and 24 will also be made.

  2. Efficacy of administration of adipose tissue-derived mesenchymal stem cells measured by the NIHSS [ Time Frame: Up to 24 months after treatment or placebo administration ]
    National Institute of Health Stroke Scale. It will be measured at all scheluded visits. Success is defined as an improvement of 75% or more from baseline. An additional exploratory analysis will look for differences in the distribution of median 8IQR) and in the frequency of NIHSS ≤ 1between groups.

  3. Efficacy of administration of adipose tissue-derived mesenchymal stem cells measuring blood brain repair biomarkers [ Time Frame: Up to 3 months after treatment or placebo administration ]
    Brain repair biomarkers in blood samples (GM-CSF, PDGF-BB, BDNF, VEGF, TGF-1, GFAP, MBP, MMP-3 and extracelular vesicles) measured at baseline, day 7 and mnth 3 after treatment or placebo administration.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ischemic stroke patients > 18 years old
  • Patients must be able to be treated within the first 4 days (+/- 1) from acute stroke symptoms onset. If the time of symptom onset is unknown, this shall refer to the last time the patient was observed as asymptomatic.
  • A computed tomography (CT) or magnetic resonance imaging (MRI) scan compatible with the clinical diagnosis of acute non-lacunar IS in the region of the middle cerebral artery (with cortical or subcortical involvement).
  • A score on the National Institute of Health Stroke Scale (NIHSS) of 8-20, with at least two of these points in sections 5 and 6 (motor deficit) at the time of inclusion and in which a measurable focal neurologic deficit persists to the time of treatment.
  • A prestroke score on the Modified Rankin Scale (mRS) ≤1 (no significant disability).
  • Female subjects non-child bearing potential. Female subjects who are of non-childbearing potential are defined as meeting at least 1 of the following criteria:

Have undergone a documented hysterectomy and/or bilateral oophorectomy; Have medically confirmed ovarian failure; or Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause.

  • Female subjects of child-bearing potential need a negative pregnancy test and must agree to use adequate contraception for the duration of the study (from screening through the final of the study). The following types of contraception are considered adequate provided they are locally authorized for use: oral, transdermal, or injectable (depot) estrogen and/or progestogen, selective estrogen receptor modulator therapy, intrauterine contraceptive device, double barrier method (e.g., condom and diaphragm or spermicidal gel) or vasectomy.
  • Signed informed consent

Exclusion Criteria:

  • Comatose patients; patients with a score of 2 or more on item 1a of the NIHSS related to the degree of awareness.
  • Current drug or alcohol use or dependence
  • Active infectious disease, including human immunodeficiency virus, hepatitis B, and hepatitis C. A controlled infection is not an exclusion criterion.
  • Pre-existing dementia.
  • A health status, any clinical condition (eg, short life expectancy, and coexisting disease or a surgical or endovascular planned procedure) or other characteristic that precludes appropriate diagnosis, treatment, or follow-up in the trial.
  • Patients who are participating in another clinical trial.
  • Inability or unwillingness of the individual or their legal guardian/representative to provide written informed consent.

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Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT04280003    
Other Study ID Numbers: AMASCIS - 02
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Pharmaceutical Solutions