Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
Phase I, Single Center, Prospective, Non-randomized, Open Label, Safety/Efficacy Study of the Infusion of Autologous Bone Marrow-derived Stem Cells, in Patients With Amyotrophic Lateral Sclerosis
A Phase I, single center, prospective, non-randomized, open label, safety/efficacy study of
the infusion of autologous bone marrow-derived stem cells, in 6 patients with Amyotrophic
Lateral Sclerosis according to established criteria (1), (2) with a moderate to severe
diagnosis of ALS according to the World Federation of Neurology El Escorial criteria.
The primary purpose of this study is to evaluate safety of the infusion procedure, as
assessed by absence of complications at the site of infusion or the appearance of new
neurologic deficit not attributed to the natural progression of the disease.
Secondary outcomes will include a)neurological evidence of trends toward a slowing down of
the decline of the forced vital capacity (FVC) (3) and of the functional rating scale
(ALS-FRS) scores, as assessed at 3-month intervals, b)evidence of a decline of the maximum
voluntary isometric contraction-arm (MVIC-arm) and MVIC-grip Z (4) scores and c)patient
evaluation that the treatment was effective and consider the possibility of a new cell
product stem cell infusion.
Subjects who fulfill inclusion/exclusion criteria and sign informed consent will undergo an
aspiration of bone marrow from the iliac crest for preparation of the cellular product.
The day of infusion, the investigational product will be injected into the patient's
intrathecal space.
After cell infusion patients will be followed at WK 2, MN 1, MN 2, MN 6 and a long-term
followup at MN 12 in the clinic and/or office. Electromyographic (EMG) studies, Forced vital
capacity (FVC), functional rating scale (FRS) and maximum voluntary isometric
contraction-arm (MVIC-arm) and MVIC-grip Z scores will have been used to assess the status
of the disease before (historical record acceptable if done within three months of Screening
Visit) and during the 12-month study period after cell infusion.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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