Study Purpose:
The purpose of this study is to determine the safety of injecting mesenchymal stem cells through intraspinal delivery for the treatment of ALS.Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Biological
Intervention Name:
autologous mesenchymal stem cells
Placebo:
Phase:
Phase 1
Study Chair(s)/Principal Investigator(s):
Anthony J. Windebank, MD, Mayo Clinic
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Mayo Clinic
Rochester, Minnesota, 55905 United States
Full Study Summary:
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 Sponsor:
Mayo Clinic
Participant Duration:
Two years
Estimated Enrollment:
1
Estimated Study Start Date:
11 / 02 / 2016
Estimated Study Completion Date:
04 / 01 / 2011
Posting Last Modified Date:
05 / 03 / 2012
Date Study Added to neals.org:
06 / 11 / 2010
Minimum Age:
18 Years
Maximum Age:
N/A
Can participants use Riluzole?
Yes
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
Mayo Clinic
Rochester, Minnesota
55905
United States