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 8 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.
Male and female patients 14 - 78 years of age
Patient should provide evidence of TBI or non -TBI as evidenced by documentation in their medical records and imaging that was done within the past 3 years.
Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable, patch, or intravaginal).
Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).
Women who are currently pregnant or lactating.
The patient has any active infection requiring medications per PI's discretion.
The patient has any clinical signs or symptoms of infection per PI's discretion.
The patient has hyperthermia or hypothermia.
HB- adMSCs (Hope Biosciences adipose derived mesenchymal stem cells)
Biological/VaccineParticipants 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.
Click on the lead sponsor to view all of their trials.
