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

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ClinicalTrials.gov Identifier: NCT01142856
Recruitment Status : Completed
First Posted : June 11, 2010
Last Update Posted : May 3, 2012
Sponsor:
Information provided by:
Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Biological: autologous mesenchymal stem cells Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Patient Treatment Protocol for Autologous Mesenchymal Stem Cell Intraspinal Therapy in Amyotrophic Lateral Sclerosis (ALS)
Study Start Date : June 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

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Arms and Interventions
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Intervention Details:
  • Biological: autologous mesenchymal stem cells
    single intrathecal dose of 10x6 cells by lumbar puncture.

Outcome Measures
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Primary Outcome Measures :
  1. Safety [ Time Frame: 2 year follow-up ]
    Clinical monitoring of possible reaction to intrathecal MSC delivery including blood pressure, temperature and pain score.


Secondary Outcome Measures :
  1. Neurologic disability score [ Time Frame: Two year follow-up ]
    Quantitative, summated, manual muscle testing


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01142856


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Anthony J. Windebank, MD Mayo Clinic
More Information
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Responsible Party: Anthony J. Windebank, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01142856    
Other Study ID Numbers: 09-001995
First Posted: June 11, 2010    Key Record Dates
Last Update Posted: May 3, 2012
Last Verified: May 2012
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases