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

NCT04825613 | Unknown

• 1 other identifier: HBPLS01
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

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 improvement over the progression of this disease.

Conditions

Primary Lateral Sclerosis, Adult, 1

Keywords

Primary Lateral Sclerosis, PLS, Sclerosis

Interventions

HB-adMSCs BIOLOGICAL

Hope Biosciences adipose derived Mesenchymal Stem Cells

Also known as: MSC's

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hope Biosciences Research Foundation: lead

Study Sites (1)

Hope Biosciences Stem Cell Research Foundation

Sugar Land, Texas, 77478, United States

Location

MeSH Terms

Conditions

Primary Lateral Sclerosis, Adult, 1; Motor Neuron Disease; Papillon-Lefevre Disease; Sclerosis

Condition Hierarchy (Ancestors)

Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases; Keratoderma, Palmoplantar; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Djamchid Lotfi, MD

  Hope Biosciences Stem Cell Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 1, 2021
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

US (1)