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

Individual Patient Expanded Access IND (Investigational New Drug) of Autologous HB-adMSCs for the Treatment of Spinal Cord Injury

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT03925649
Enrollment
Unknown
Registered
2019-04-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury at C5-C7 Level

Keywords

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

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)

Detailed description

This is an expanded access single-dose study with the primary goal of treatment submitted at the request of an individual patient with complete C5-6 spinal cord injury (SCI) resulting in quadriplegia who does not qualify for any current clinical trials and for whom there are no other FDA approved fully restorative treatments. The overall objective of this study is to evaluate patient's response, adverse events and serious adverse events (AE/SAEs), and cell expansion characteristics of a single intravenous (IV) infusion of autologous adipose-derived mesenchymal stem cells (HB-adMSCs) in a subject with complete SCI resulting in quadriplegia.

Interventions

BIOLOGICALHB-adMSCs

single infusion of HB-adMSCs

Sponsors

The University of Texas Health Science Center, Houston
CollaboratorOTHER
Hope Biosciences LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

1. 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 2. Having a contraindication to MRI scans 3. 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 4. Participation in other interventional research studies 5. Unwillingness to return for follow-up visits

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026