Expired Study
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Rochester, Minnesota 55905


Purpose:

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


Study summary:

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.


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


NCT ID:

NCT01142856


Primary Contact:

Principal Investigator
Anthony J. Windebank, MD
Mayo Clinic


Backup Contact:

N/A


Location Contact:

Rochester, Minnesota 55905
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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