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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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18 January 2016 |
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Main ID: |
NCT01640067 |
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Date of registration:
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09/07/2012 |
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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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Human Neural Stem Cell Transplantation in Amyotrophic Lateral Sclerosis (ALS)
hNSCALS |
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Scientific title:
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Intra-spinal Cord Delivery of Human Neural Stem Cells in ALS Patients: Proposal for a Phase I Study/ Trapianto Intramidollare di Cellule Staminali Neurali Umane Come Terapia Putativa Per la SLA: Proposta di un Trial Clinico di Fase I |
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Date of first enrolment:
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December 2011 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01640067 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
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Phase:
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Phase 1
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Countries of recruitment
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Italy
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Contacts
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Name:
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Angelo L Vescovi, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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IRCCS Casa Sollievo della Soffernza and AOSP Terni, Italy |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of definite or possible ALS according to revised EL Escorial criteria
- Age: 20-75 years
- documented progression of disease during the last 6 months.
- Absence of concomitant diseases
- Adequate assurances of adherence to protocol
- The patient must be able to communicate verbally or with the use of non-verbal
communication system
Group 1
- maximum score of 1 on walking item of ALS functional rating scale
- forced vital capacity > or equal to 60
Group 2
- forced vital capacity > or equal to 60
- ambulation difficulties (maximum score of 2 on walking item of ALS functional rating
scale)
Group 3
- Independent ambulation (score 4 on a scale ALS-FRS)
- forced vital capacity > or equal to 70
Exclusion Criteria:
The presence of at least one of the following will lead to patient exclusion.
1. psychiatric diseases or other neurological diseases different from ALS
2. other systemic diseases
3. Neoplasms or other diseases reducing life expectancy
4. Antecedent polio infection
5. corticosteroids, immunoglobulin or immunosuppressive treatment
6. involvement in other clinical trials
7. 2 or more critical items in MMPI
8. neuropsychological evaluation suggestive of mental deterioration or cognitive sphere
disturbance.
9. Impediments to MRI
10. patients unable to understand informed consent form and study aims.
11. women who are pregnant or childbearing potential for the duration of the study.
Non-pregnant status will be documented by beta-HCG negative test 7 days before
treatment start
Age minimum:
20 Years
Age maximum:
75 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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Biological: Human Neural Stem Cells
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Primary Outcome(s)
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safety of a microsurgery human neural stem cells transplantation into spinal cord of ALS patients
[Time Frame: Participants will be followed for at least 3 years. Monthly in the first year and every three months the following two years]
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Secondary ID(s)
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EudraCT: 2009-014484-39
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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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