A Dose-escalation Safety Trial for Intrathecal Autologous Mesenchymal Stem Cell Therapy in Amyotrophic Lateral Sclerosis

Inclusion Criteria:

- All patients must have clinically-defined ALS as defined by the World Federation of
Neurology criteria

- Age greater than 18 years

- If female, must be post-menopausal or had a hysterectomy

- Permanent resident or citizen of the United States

- History of a chronic onset of a progressive motor weakness of less than two years
duration

- Able to comply with protocol requirements, including MRI testing

- Can provide written informed consent

Exclusion Criteria:

- Any clinically significant medical condition (e.g., within six months of baseline,
had myocardial infarction, angina pectoris, and/or congestive heart failure) that, in
the opinion of the investigator, would compromise the safety of patient.

- Autoimmunity, including Crohn's disease, rheumatoid arthritis, psoriasis

- Malignancy including melanoma with the exception of localized skin cancers (with no
evidence of metastasis, significant invasion, or re-occurrence within three years of
baseline). Any other malignancy will not be allowed.

- Active systemic or local infection near the lumbar puncture site

- Other active systemic disease as defined by laboratory abnormalities

- Use of herbal medications or other unapproved drugs

- Enrolled in an investigational drug trial within 30 days of baseline visit

- Kokmen Short Test of Mental Status score <32

- Beck's Depression Inventory score >18

- Presence of a tracheostomy

- Ventilator dependent