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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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5 September 2016 |
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Main ID: |
NCT02881476 |
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Date of registration:
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22/04/2016 |
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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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Therapeutic Treatment of Amyotrophic Lateral Sclerosis
UwmWjmscAls |
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Scientific title:
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Application of Wharton's Jelly-derived Mesenchymal Stem Cells in the Treatment of Amyotrophic Lateral Sclerosis |
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Date of first enrolment:
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November 2015 |
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Target sample size:
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30 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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https://clinicaltrials.gov/show/NCT02881476 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Contacts
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Name:
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Wojciech Maksymowicz, MD, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Faculty of Medical Sciences, University of Warmia and Mazury in Olsztyn, Poland |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- diagnosis of the ALS disease before the cell transplantation (diagnose established
following the El Escorial criteria for definite ALS)
- good understanding of the protocol and willingness to consent
- signed informed consent
- disease duration: up to 2 years
- FVC > 50% / pulmonologist certificate about respiratory function of the patient
Exclusion Criteria:
- cancer,
- autoimmune diseases
- renal failure,
- subject is a respiratory dependent.
- subject unwilling or unable to comply with the requirements of the protocol
- pregnancy, breastfeeding
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis
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Intervention(s)
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Other: Biological: Cell-based therapy
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Primary Outcome(s)
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Changes in the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) between patients before and after stem cell transplantation.
[Time Frame: From day of enrolment until the date of first stem cell injection (6 months - first time ALSFRS) + and then every 2 months up to 1,5 year of the trial]
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Secondary ID(s)
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UWM/ALS-MSC.2015/001
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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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