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)
1 other identifier
interventional
1
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 10, 2010
CompletedFirst Posted
Study publicly available on registry
June 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedMay 3, 2012
May 1, 2012
10 months
June 10, 2010
May 2, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Safety
Clinical monitoring of possible reaction to intrathecal MSC delivery including blood pressure, temperature and pain score.
2 year follow-up
Secondary Outcomes (1)
Neurologic disability score
Two year follow-up
Interventions
single intrathecal dose of 10x6 cells by lumbar puncture.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anthony J. Windebank, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 10, 2010
First Posted
June 11, 2010
Study Start
June 1, 2010
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
May 3, 2012
Record last verified: 2012-05