"Individual Patient Expanded Access IND to Evaluate the Safety and Efficacy of HB-adMSCs for the Treatment of Primary Lateral Sclerosis"

HBPLS01

This Individual Patient Expanded Access IND has been created as requested by an 83-year-old man who suffers Primary Lateral Sclerosis and for which the drugs currently approved are not providing an improvement over the progression of this disease.

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HBPLS01 Inclusion Criteria: 1. Adult individual at least 18 years old 2. Clinical diagnosis Primary Lateral Sclerosis. 3. Subject or Legal Authorized Representative has provided informed consent before initiation of any study procedure. 4. Subject has mesenchymal stem cells banked at Hope Biosciences. Exclusion Criteria: 1. Clinically significant, uncontrolled cardiovascular, lung, renal, hepatic, or endocrine disease or any other acute or chronic medical condition that, in the opinion of the principal investigator, may increase the risks associated with study participation. 2. Chemical or ETOH dependency that in the opinion of the investigator would preclude participation in the study. 3. Participation in concurrent interventional research studies during this expanded access. 4. Unwillingness to return for follow-up visits.

{'studyType': 'EXPANDED_ACCESS'}

2023-06-08