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

- Biological: autologous mesenchymal stem cells
single intrathecal dose of 10x6 cells by lumbar puncture.
- Safety [ Time Frame: 2 year follow-up ]Clinical monitoring of possible reaction to intrathecal MSC delivery including blood pressure, temperature and pain score.
- Neurologic disability score [ Time Frame: Two year follow-up ]Quantitative, summated, manual muscle testing

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | Anthony J. Windebank, MD | Mayo Clinic |
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 |
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 |