A Dose-escalation Safety Trial for Intrathecal Autologous Mesenchymal Stem Cell Therapy in Amyotrophic Lateral Sclerosis

Completed · Phase 1

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

The purpose of this study is to determine determine the safety of intraspinal delivery of mesenchymal stem cells (MSCs) to the cerebral spinal fluid of patients with Amyotrophic Lateral Sclerosis (ALS) using a dose-escalation study.

Key facts

Study ID

NCT01609283

Run by

Mayo Clinic

People needed

27

Starts

2012-05-01

Expected to finish

2019-01-31

Last updated by the study team

2019-09-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients must have clinically-defined ALS as defined by the World Federation of Neurology criteria
• Age greater than 18 years
• If female, must be post-menopausal or had a hysterectomy
• Permanent resident or citizen of the United States
• History of a chronic onset of a progressive motor weakness of greater than one year, but less than two years duration
• Must have vital capacity greater than 65% of predicated for age, gender, and body type
• Able to comply with protocol requirements, including MRI testing
• Can provide written informed consent

You may not qualify if…

• Any clinically significant medical condition (e.g., within six months of baseline, had myocardial infarction, angina pectoris, and/or congestive heart failure) that, in the opinion of the investigator, would compromise the safety of patient.
• Autoimmunity, including Crohn's disease, rheumatoid arthritis, psoriasis
• Malignancy including melanoma with the exception of localized skin cancers (with no evidence of metastasis, significant invasion, or re-occurrence within three years of baseline). Any other malignancy will not be allowed.
• Active systemic or local infection near the lumbar puncture site
• Other active systemic disease as defined by laboratory abnormalities
• Use of herbal medications or other unapproved drugs
• Enrolled in an investigational drug trial within 30 days of baseline visit
• Kokmen Short Test of Mental Status score <32
• Beck's Depression Inventory score >18
• Presence of a tracheostomy
• Ventilator dependent

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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