A Study of the Safety of Mesenchymal Stem Cells for Treatment of One Patient with Amyotrophic Lateral Sclerosis (ALS)

Overview

About this study

The purpose of this study is to determine the safety of injecting mesenchymal stem cells through intraspinal delivery for the treatment of one patient who has amyotrophic lateral sclerosis (ALS).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Age greater than 18 years
  • If female, must be menopausal or had a hysterectomy
  • Resident and citizen of the United States
  • History of chronic onset of a progressive motor weakness
  • Able to comply with protocol requirements
  • Can provide written consent

Exclusion Criteria

  • Does not have renal disease with Creatine > 2.0
  • Does not have active systemic disease
  • Does not have any clinically significant abnormalities on prestudy laboratory evaluation
  • Has not had any clinically significant medical condition 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Anthony Windebank, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20314725

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