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

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01142856
First received: June 10, 2010
Last updated: May 2, 2012
Last verified: May 2012

June 10, 2010
May 2, 2012
June 2010
April 2011   (final data collection date for primary outcome measure)
Safety [ Time Frame: 2 year follow-up ] [ Designated as safety issue: Yes ]
Clinical monitoring of possible reaction to intrathecal MSC delivery including blood pressure, temperature and pain score.
Same as current
Complete list of historical versions of study NCT01142856 on ClinicalTrials.gov Archive Site
Neurologic disability score [ Time Frame: Two year follow-up ] [ Designated as safety issue: No ]
Quantitative, summated, manual muscle testing
Same as current
Not Provided
Not Provided
 
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)

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

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Amyotrophic Lateral Sclerosis
Biological: autologous mesenchymal stem cells
single intrathecal dose of 10x6 cells by lumbar puncture.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01142856
09-001995
Not Provided
Anthony J. Windebank, M.D., Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Anthony J. Windebank, MD Mayo Clinic
Mayo Clinic
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP