NCT07164482

Intermediate Size Patient Population Expanded Access Protocol to Evaluate HB-adMSCs for the Treatment of Patients With Traumatic or Nontraumatic Brain Injury

"An Intermediate Size Patient Population Expanded Access Protocol to Evaluate the Safety and Efficacy of Allogeneic HB-adMSCs for the Treatment of Patients With Traumatic or Nontraumatic Brain Injury"

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Hope Biosciences Research Foundation · Industry
• Sex: All
• Age: 14 Years – 78 Years
• Healthy volunteers: —

Summary

This expanded access protocol is part of IND 031942 to evaluate efficacy and safety of multiple intravenous administrations of allogeneic HB-adMSCs for the treatment of nontraumatic or traumatic brain injury for up to 7 patients who passed pre-screening, completed screening, and were not randomized into the treatment group for the HBBI01 clinical study protocol entitled, "An Intermediate Size Patient Population Expanded Access Protocol to Evaluate the Safety and Efficacy of Allogeneic HB-adMSCs for the Treatment of Patients with Traumatic or Nontraumatic Brain Injury." under IND 027396.

Conditions

• Brain Injury

Interventions

Type	Name	Description
BIOLOGICAL	HB- adMSCs (Hope Biosciences adipose derived mesenchymal stem cells)	Participants will receive allogenic HB-adMSCs through intravenous infusion only, with a treatment duration of 16 weeks, infusion rate 4-5mL/min and total volume of 250 mL Sodium chloride 0.9%. Each participant will receive a total of 6 doses of HB-adMSCs with a dosing regimen of approximately 2 weeks between infusion 1, infusion 2 and infusion 3, and 4 weeks between the remaining infusions.

Timeline

• First posted: 2025-09-10
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States