NCT05951777

Autologous Adipose-Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Hope Biosciences LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The global objective of this study is to establish the safety and investigate the potential treatment effect of an intravenous infusion of HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) on brain structure, neurocognitive/functional outcomes, and neuroinflammation after traumatic brain injury.

Detailed description

This study is a prospective, randomized, double-blind, placebo-controlled Phase 2a study of three infusions of autologous HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) (2 x 10\^8 total cells per dose) administered over a 6 week period with 14 day intervals between infusions. Subjects will be monitored and assessed for infusion related toxicity for at least 1 hour after the infusion and by telephone 24hr. after each infusion. Safety assessments will be conducted at the study follow-up clinic visits 6 and 12 months, and 2 years (telephone call) after the last HB-adMSC (Hope Biosciences adipose-derived mesenchymal stem cells) infusion, or more frequently if infusion related adverse events are suspected.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
BIOLOGICAL	Autologous HB-adMSCs	Hope Biosciences autologous adipose-derived mesenchymal stem cells
DRUG	Normal Saline	Sterile Saline Solution 0.9%

Timeline

• Start date: 2024-04-16
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2023-07-19
• Last updated: 2025-09-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study