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

NCT ID: NCT01142856

Last Updated: 2012-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-04-30

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). 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.

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

autologous mesenchymal stem cells

single intrathecal dose of 10x6 cells by lumbar puncture.

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mayo Clinic

Principal Investigators

Anthony J. Windebank, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

09-001995

Identifier Type: -

Identifier Source: org_study_id