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

Phase 1

Completed

• Conditions: Amyotrophic Lateral Sclerosis

• Registration Number: NCT01142856
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-10
• Study First Submitted QC: 2010-06-10
• Study First Posted: 2010-06-11
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-02
• Last Update Posted: 2012-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety	2 year follow-up	Clinical monitoring of possible reaction to intrathecal MSC delivery including blood pressure, temperature and pain score.

Secondary Outcome Measures

Name	Time	Method
Neurologic disability score	Two year follow-up	Quantitative, summated, manual muscle testing

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States