NCT04063215

A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy for the Treatment of Traumatic Brain Injury and Hypoxic-Ischemic Encephalopathy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Hope Biosciences LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study aims to determine the safety of HB-adMSC infusion and treatment effects of HB-adMSC infusion on brain structure, neurocognitive/functional outcomes, and neuroinflammation after subacute and chronic neurological injury in adults.

Detailed description

This study aims to determine the safety of HB-adMSC infusion and treatment effects of HB-adMSC infusion on global gray and/or white matter, as well as structural integrity of GM and WM regions of interest in the corpus callous and corticospinal tracts as measured by fractional anisotropy (FA) and mean diffusivity (MD) in specific regions known to correlate with specific neurocognitive deficits in patients after neurological injury.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
BIOLOGICAL	HB-adMSCs	Hope Biosciences autologous adipose-derived mesenchymal stem cells

Timeline

• Start date: 2020-01-01
• Primary completion: 2024-10-25
• Completion: 2024-10-25
• First posted: 2019-08-21
• Last updated: 2026-01-15
• Results posted: 2026-01-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study