Individual Patient Expanded Access IND of Autologous HBadMSCs for the Treatment of Amyotrophic Lateral Sclerosis

NCT04514952 | Unknown

• 1 other identifier: HBALS01
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The drug for this submission is Hope Biosciences' autologous, adipose-derived culture-expanded mesenchymal stem cells (HB-adMSCs) for the treatment of a single patient with Amyotrophic Lateral Sclerosis (ALS). Stem cells have become a promising tool for the treatment of inflammatory and neurodegenerative conditions, including autoimmune diseases, traumatic brain injury, Parkinson's disease, and Alzheimer's disease.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Neurodegenerative; MSCs; Stem cells; Sclerosis; ALS; Amyotrophic

Interventions

HB-adMSCs BIOLOGICAL

Hope Biosciences autologous adipose-derived mesenchymal stem cells

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented diagnosis of Amyotrophic Lateral Sclerosis.
• Capable of giving informed consent (signed, verbal or assent as applicable and as listed in the protocol)

You may not qualify if:

• Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation or HB-adMSCs administration.
• Any abnormal, inexplicable laboratory result that, in the opinion of the investigator, may increase the risks associated with study participation or HB-adMSCs administration.
• Participation in other interventional research studies within the past 30 days.
• Unwillingness to return for follow-up visits.

Sponsors & Collaborators

• Hope Biosciences Research Foundation: lead

Study Sites (1)

River Oaks Hospital and Clinics

Houston, Texas, 77027, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rajiv Thakur, MD

  River Oaks Hospital and Clinics

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 17, 2020
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

US (1)