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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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19 February 2015 |
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Main ID: |
NCT02193893 |
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Date of registration:
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16/07/2014 |
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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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Biological Treatment of Amyotrophic Lateral Sclerosis
NeuStem-ALS |
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Scientific title:
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Safety/Efficacy Study for the Biological Treatment of Amyotrophic Lateral Sclerosis With Autologous Stem/Progenitor Cells |
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Date of first enrolment:
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January 2010 |
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Target sample size:
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50 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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http://clinicaltrials.gov/show/NCT02193893 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Poland
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Contacts
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Name:
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Przemyslaw Nowacki, 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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Pomeranian Medical University Szczecin |
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Name:
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Boguslaw Machalinski, 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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Pomeranian Medical University Szczecin |
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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
- patient is mentally intact and psychologically stable
- signed informed consent
Exclusion Criteria:
Concomitant of other systemic disease or diseases:
- inflammation (high protein or lymphocytosis in the CSF), active infections.
- diabetes,
- cardio-vascular disorders,
- cancer,
- autoimmune diseases
- renal failure,
- impaired hepatic function.
- subject is a respiratory dependent.
- subject unwilling or unable to comply with the requirements of the protocol.
- patient has been treated previously with any cellular therapy.
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 therapeutics
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Other: Symptomatic treatment of ALS
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Primary Outcome(s)
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Safety of autologous bone marrow stem/progenitor cell infusion in enrolled patients
[Time Frame: 1 year]
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Secondary Outcome(s)
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Efficacy of autologous bone marrow stem/progenitor cell infusion in enrolled patients.
[Time Frame: 1 year]
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Secondary ID(s)
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ZPO 02, ALS-BMSC #01
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ZPO 02
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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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