"Individual Patient Expanded Access IND to Treat Primary Lateral Sclerosis"

Status:

NO_LONGER_AVAILABLE

"Individual Patient Expanded Access IND to Treat Primary Lateral Sclerosis"

Lead Sponsor:

Hope Biosciences Research Foundation

Conditions:

Primary Lateral Sclerosis, Adult, 1

Eligibility:

MALE

18+ years

Brief Summary

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 im...

Detailed Description

-Screening This expanded access IND was created at the request of the subject who already has his own stem cells banked at Hope Biosciences, LLC. After receiving authorization from FDA and Western IRB...

Eligibility Criteria

Inclusion

HBPLS01
Adult individual at least 18 years old
Clinical diagnosis Primary Lateral Sclerosis.
Subject or Legal Authorized Representative has provided informed consent before initiation of any study procedure.
Subject has mesenchymal stem cells banked at Hope Biosciences.

Exclusion

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.
Chemical or ETOH dependency that in the opinion of the investigator would preclude participation in the study.
Participation in concurrent interventional research studies during this expanded access.
Unwillingness to return for follow-up visits.

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04825613

Last Update

September 29 2025

Active Locations (1)

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