Mesenchymal Stem Cells for Treatment of Amyotrophic Lateral Sclerosis (ALS)
This study has been completed.
Sponsor:
Mayo Clinic
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01142856
First received: June 10, 2010
Last updated: May 2, 2012
Last verified: May 2012
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Purpose
The purpose of this study is to determine the safety of injecting mesenchymal stem cells through intraspinal delivery for the treatment of ALS.
| Condition | Intervention | Phase |
|---|---|---|
|
Amyotrophic Lateral Sclerosis |
Biological: autologous mesenchymal stem cells |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Single Patient Treatment Protocol for Autologous Mesenchymal Stem Cell Intraspinal Therapy in Amyotrophic Lateral Sclerosis (ALS) |
Resource links provided by NLM:
Genetics Home Reference related topics:
amyotrophic lateral sclerosis
MedlinePlus related topics:
Amyotrophic Lateral Sclerosis
U.S. FDA Resources
Further study details as provided by Mayo Clinic:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- Neurologic disability score [ Time Frame: Two year follow-up ] [ Designated as safety issue: No ]Quantitative, summated, manual muscle testing
| Enrollment: | 1 |
| Study Start Date: | June 2010 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Biological: autologous mesenchymal stem cells
single intrathecal dose of 10x6 cells by lumbar puncture.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01142856
Please refer to this study by its ClinicalTrials.gov identifier: NCT01142856
Locations
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
Sponsors and Collaborators
Mayo Clinic
Investigators
| Principal Investigator: | Anthony J. Windebank, MD | Mayo Clinic |
More Information
No publications provided
| Responsible Party: | Anthony J. Windebank, M.D., Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01142856 History of Changes |
| Other Study ID Numbers: | 09-001995 |
| Study First Received: | June 10, 2010 |
| Last Updated: | May 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Amyotrophic Lateral Sclerosis Motor Neuron Disease Sclerosis Central Nervous System Diseases Metabolic Diseases Nervous System Diseases |
Neurodegenerative Diseases Neuromuscular Diseases Pathologic Processes Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies |
ClinicalTrials.gov processed this record on March 01, 2015