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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 April 2022 |
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Main ID: |
NCT02290886 |
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Date of registration:
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09/10/2014 |
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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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A Multicenter Phase I/II Clinical Trial to Evaluate Safety of Mesenchymal Stem Cell in Patients With Amyotrophic Sclerosis Lateral
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Scientific title:
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A Multicenter Phase I/II Clinical Trial, Randomized, Controlled With Placebo, Triple Blind to Evaluate Safety, and Indications of Efficiency of the Intravenous Administration of the Therapy With 3 Doses of MSC in Patients With ASL Moderated to Severe |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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52 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02290886 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Spain
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Contacts
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Name:
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Óscar Fernández, 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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Hospital Regional U. de Málaga |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Women and males over 18-year-old.
2. Good understanding of the protocol and aptitude to grant the informed assent.
3. Diagnosis of sporadic ALS, with diagnosis of certainty, that is to say, definite or
probable, in agreement with the criteria of "El Escorial", of the World Federation of
Neurology.
4. Forced vital capacity of at least 50 % of the one that would correspond to them for
sex, height and age.
5. More than 6 and less than 36 months of evolution of the disease (from the beginning of
the symptoms).
6. Possibility of obtaining, at least, 50gr of adipose tissue.
7. Treatment with riluzole, for at least, a month before the inclusion.
Exclusion Criteria:
1. Any concomitant disease that under investigator's criteria could concern the measures
of the clinical variables of the trial (hepatic, renal or cardiac insufficiency,
diabetes mellitus, etc).
2. Previous therapy with stem cells.
3. Participation in another clinical trial during 3 months previous to the entry in this
trial.
4. Any disease lymphoproliferative
5. Tracheostomy and /or gastrostomy.
6. Haemophilia, diathesis hemorrhagic or anticoagulative current therapy.
7. Hypersensitivity known to the bovine foetal whey or the gentamicin.
8. Medical precedents of infection of the HIV or any serious condition of
immunocompromised.
9. Positive HBV or HCV serology
10. Levels of creatinine in whey > 3.0 in subjects not submitted to haemodialysis.
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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Amyotrophic Lateral Sclerosis
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Intervention(s)
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Other: Intravenous administration of placebo
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Drug: Intravenous administration of 1 million of MSC
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Drug: Intravenous administration of 2 million of MSC
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Drug: Intravenous administration of 4 million of MSC
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Primary Outcome(s)
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Appearance of a new neurological effect not attributable to the natural progression of this pathology
[Time Frame: 6 months]
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Number of adverse serious unexpected reactions or not, attributable to the treatment (SUSSARs or SAE)
[Time Frame: 6 months]
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Complications in the place of the infusion
[Time Frame: 6 months]
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Secondary Outcome(s)
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Changes in the progression of the disease (modifications in the scale of functionality of the ALS)
[Time Frame: 6 months]
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Changes in the degree of muscular force
[Time Frame: 6 months]
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Need and time to tracheotomy or permanent assisted ventilation
[Time Frame: 6 months]
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Changes in neurophysiological parameters and of quality of life
[Time Frame: 6 months]
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Changes of the muscular mass estimated by Nuclear Magnetic Resonance (NMR) of the upper and low extremities
[Time Frame: 6 months]
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Changes in the vital forced capacity
[Time Frame: 6 months]
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Secondary ID(s)
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CeTMAd/ELA/2011
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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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