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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02987413 |
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Date of registration:
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01/07/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Escalated Application of Mesenchymal Stem Cells in Amyotrophic Lateral Sclerosis Patients
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Scientific title:
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Safety and Efficacy of Mesenchymal Stem Cells Escalated Application in Amyotrophic Lateral Sclerosis Patients: Study Design of a Phase I Trial |
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Date of first enrolment:
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April 28, 2015 |
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Target sample size:
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3 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02987413 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Eliseo J Sekiya, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto de Ensino e Pesquisas - IEP-São Lucas |
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Name:
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Sergio S Jordy, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clínica Jordy Sinapse |
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Name:
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Adelson A Silva, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto de Ensino e Pesquisas - IEP-São Lucas |
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Name:
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Leandro B Agati, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital e Maternidade Dr Christovao da Gama |
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Name:
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Andresa Forte, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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TECHLIFE - Centro de Tecnologia Celular |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Women and males over 18-year-old.
- Diagnosis of ALS in agreement with the criteria of "EL SCORE"
- Less than 24 months of evolution of the disease (from the beginning of the symptoms).
- Good understanding of the protocol and aptitude to grant the informed consent
- Infertile women (post-menopause or hysterectomized)
- Brazilian citizen and permanent resident.
Exclusion Criteria:
- Any significant medical condition (congestive heart failure, angina, respiratory
failure, and others)
- Any auto-immune disease
- Any malignant diseases
- Systemic infection
- Mental illness
- Depressive state
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Motor Neuron Disease
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Intervention(s)
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Biological: Autologous Mesenchymal stem cells (MSCs)
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Primary Outcome(s)
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Serious Adverse Events related to the treatment
[Time Frame: 12 months]
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Secondary Outcome(s)
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Revised ALS Functional Rating Scale (ALSFRS-R)
[Time Frame: 12 months]
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Secondary ID(s)
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IEPSaoLucas
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HospitalMCG
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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