Status:
COMPLETED
Mesenchymal Stem Cells for Treatment of Amyotrophic Lateral Sclerosis (ALS)
Lead Sponsor:
Mayo Clinic
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01142856
Start Date
June 1 2010
End Date
April 1 2011
Last Update
May 3 2012
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905