Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
A Dose-escalation Safety Trial for Intrathecal Autologous Mesenchymal Stem Cell Therapy in Amyotrophic Lateral Sclerosis
The purpose of this study is to determine determine the safety of intraspinal delivery of mesenchymal stem cells (MSCs) to the cerebral spinal fluid of patients with Amyotrophic Lateral Sclerosis (ALS) using a dose-escalation study.
The primary objective of this study is to determine the safety of intrathecal delivery of
autologous mesenchymal stem cells (MSCs) to the cerebrospinal fluid (CSF) of patients with
ALS using a dose-escalation study. The trial will include 25 adult, non-ventilator-dependent
patients with clinically definite amyotrophic lateral sclerosis (ALS). Cells will be isolated
from adipose tissue, expanded ex vivo and then, after ~8 weeks, intrathecal (IT) autologous
delivery of MSCs will be performed. There will be 5 treatment groups of up to 5 patients
each. Groups 1, 2, and 4 will receive a single dose of cells. Groups 3 and 5 will receive 2
doses of cells separated by 1 month. Groups will be completed sequentially so that patients
will not be enrolled into the next treatment group until at least 3 patients in the preceding
group have completed the treatment and 1 month of additional observation without significant
toxicity. All patients will be followed on a regular basis until death or for a minimum of 2
years after completion of the final infusion. Initial clinical follow-up will be weekly with
scheduled blood, CSF and magnetic resonance imaging (MRI) evaluations. After 1 month,
patients will have clinical evaluations at 3 month intervals, or earlier if indicated by
clinical status.
Addendum: Five subjects from the Group 5 dosing level will received additional injections of
MSCs in an extension of the original study, if tolerated.
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