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

A Single Patient Treatment Protocol for Autologous Mesenchymal Stem Cell Intraspinal Therapy in Amyotrophic Lateral Sclerosis (ALS)

The purpose of this study is to determine the safety of injecting mesenchymal stem cells through intraspinal delivery for the treatment of 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