Individual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells for Treatment of SCI

NCT03925649 | Unknown

• 1 other identifier: HBSCI01
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is expanded access to an Investigational New Drug (IND) for an individual patient with spinal cord injury (SCI) at cervical spine 5-6 (C 5-6) designed to provide access to autologous adipose-derived mesenchymal stem cells (HB-adMSCs)

Conditions

Spinal Cord Injury at C5-C7 Level

Keywords

SCI; stem cells; quadriplegia; spinal cord injury; paralysis; MSCs

Interventions

HB-adMSCs BIOLOGICAL

single infusion of HB-adMSCs

Eligibility Criteria

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

You may qualify if:

• Cognitively intact, capable of giving informed consent
• Clinical diagnosis of a non-penetrating traumatic SCI
• Asia Impairment Scale grade of A, B, or C

You may not qualify if:

• Prior history of:
• Brain injury
• Recent or ongoing infection
• Clinically significant cardiovascular, lung, renal, hepatic or endocrine disease,
• Neurodegenerative disorders
• Cancer
• Immunosuppression as defined by WBC\<3,000 cells/ml at baseline screening,
• HIV+
• Chemical or ETOH dependency
• Having a contraindication to MRI scans
• Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation or HB-adMSC administration
• Participation in other interventional research studies
• Unwillingness to return for follow-up visits

Sponsors & Collaborators

• Hope Biosciences LLC: lead
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (1)

Memorial Hermann Hospital-Clinical Research Unit (MMH-CRU)

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Quadriplegia; Spinal Cord Injuries; Paralysis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

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

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 24, 2019
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

US (1)