Human Neural Stem Cell Transplantation in Amyotrophic Lateral Sclerosis (ALS)
NCT ID: NCT01640067
Last Updated: 2015-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2011-12-31
2015-12-31
Brief Summary
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1. to verify safety and tolerability of expanded human fetal neural stem cells
2. to verify safety and tolerability of a microsurgery human fetal neural stem cells transplantation model
3. to recognize each change in patient's quality of life
Secondary aim of the trial
1. assessment of the impact of human neural stem cells transplantation on the disability of ALS in a clinically significant and measurable way
2. Assessment of the impact of human neural stem cells transplantation on mortality (all causes)
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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Human Neural Stem Cells Suspension
50,000 cells/µl. Patients received either unilateral or bilateral hNSCs microinjections (3 microinjections on each side) into the lumbar spinal cord. Each microinjection consisted of 15 µl of the above 50,000cells/µl suspension, yielding a total of 750,000 cells per injection site.
Human Neural Stem Cells
Surgical microinjection of human neural stem cells on spinal cord of ALS patients
Interventions
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Human Neural Stem Cells
Surgical microinjection of human neural stem cells on spinal cord of ALS patients
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
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
20 Years
75 Years
ALL
No
Sponsors
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Azienda Ospedaliero Universitaria Maggiore della Carita
OTHER
Università di Padova Italy
UNKNOWN
Azienda Ospedaliera Santa Maria, Terni, Italy
OTHER
Responsible Party
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Angelo Luigi Vescovi
Scientific Director of Laboratorio Cellule Staminali, Cell Factory e Biobanca AOSP di Terni, Scientific Director IRCCS Casa Sollievo della Sofferenza S.Giovanni Rotondo Italy
Principal Investigators
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Angelo L Vescovi, Professor
Role: PRINCIPAL_INVESTIGATOR
IRCCS Casa Sollievo della Soffernza and AOSP Terni, Italy
Locations
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Azienda Ospedaliera Santa Maria
Terni, Terni, Italy
Countries
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References
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Gelati M, Profico D, Projetti-Pensi M, Muzi G, Sgaravizzi G, Vescovi AL. Culturing and expansion of "clinical grade" precursors cells from the fetal human central nervous system. Methods Mol Biol. 2013;1059:65-77. doi: 10.1007/978-1-62703-574-3_6.
Mazzini L, Gelati M, Profico DC, Sgaravizzi G, Projetti Pensi M, Muzi G, Ricciolini C, Rota Nodari L, Carletti S, Giorgi C, Spera C, Domenico F, Bersano E, Petruzzelli F, Cisari C, Maglione A, Sarnelli MF, Stecco A, Querin G, Masiero S, Cantello R, Ferrari D, Zalfa C, Binda E, Visioli A, Trombetta D, Novelli A, Torres B, Bernardini L, Carriero A, Prandi P, Servo S, Cerino A, Cima V, Gaiani A, Nasuelli N, Massara M, Glass J, Soraru G, Boulis NM, Vescovi AL. Human neural stem cell transplantation in ALS: initial results from a phase I trial. J Transl Med. 2015 Jan 27;13:17. doi: 10.1186/s12967-014-0371-2.
Gelati M, Profico DC, Ferrari D, Vescovi AL. Culturing and Expansion of "Clinical Grade" Neural Stem Cells from the Fetal Human Central Nervous System. Methods Mol Biol. 2022;2389:57-66. doi: 10.1007/978-1-0716-1783-0_5.
Robberecht W, Philips T. The changing scene of amyotrophic lateral sclerosis. Nat Rev Neurosci. 2013 Apr;14(4):248-64. doi: 10.1038/nrn3430. Epub 2013 Mar 6.
Related Links
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No profit Association that grant this study
Other Identifiers
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EudraCT: 2009-014484-39
Identifier Type: -
Identifier Source: org_study_id