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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01142856
• Date of registration: 10/06/2010
• Prospective Registration: No
• Primary sponsor: Mayo Clinic
• Public title: Mesenchymal Stem Cells for Treatment of Amyotrophic Lateral Sclerosis (ALS)
• Scientific title: A Single Patient Treatment Protocol for Autologous Mesenchymal Stem Cell Intraspinal Therapy in Amyotrophic Lateral Sclerosis (ALS)
• Date of first enrolment: June 2010
• Target sample size: 1
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01142856
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Anthony J. Windebank, MD
• Affiliation: Mayo Clinic

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Intervention(s)

Biological: autologous mesenchymal stem cells

Primary Outcome(s)

Safety [Time Frame: 2 year follow-up]

Secondary Outcome(s)

Neurologic disability score [Time Frame: Two year follow-up]

Secondary ID(s)

09-001995

Source(s) of Monetary Support

Please refer to primary and secondary sponsors