Mesenchymal Stem Cells for Treatment of Amyotrophic Lateral Sclerosis (ALS)

A single patient safety study for harvesting, expanding ex vivo and injecting autologous mesenchymal stem cells (MSC's) into the subarachnoid space of a patient with amyotrophic lateral sclerosis (ALS). Cells will be isolated from adipose tissue by subcutaneous biopsy and expanded using an FDA-approved protocol. They will then be injected by lumbar puncture into the cerebrospinal fluid. Injection will be completed in the in- patient clinical research unit (CRU). the patient will be followed for two years.

Inclusion criteria

• age greater than 18 years, if female, must be menopausal or had hysterectomy
• resident and citizen of the United States
• history of a chronic onset of a progressive motor weakness
• able to comply with protocol requirements
• can provide written consent

Exclusion criteria

• does not have renal disease (Creatine > 2.0)
• does not have active systemic disease
• does not have any clinically significant abnormalities on prestudy laboratory evaluation
• does not have any clinically significant medical condition (e.g.,within 6 months of baseline, had a myocardial infarct, angina pectoris, and/or congestive heart failure), that in the opinion of the investigator, would compromise the safety of the patient
• does not have a history of cancer including melanoma with the exception of localized skin cancers (with no evidence of metastasis, significant invasion,or re-occurrence within 3 years of baseline).
• has not used an investigational drug within 30 days of baseline visit
• does not have a tracheostomy
• does not have a Beck's Depression Inventory score >16