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

NCT07164482 · Status: AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2026-05-19

No results posted yet for this study

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 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.

Conditions

  • Brain Injury

Interventions

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.

Sponsors & Collaborators

  • Hope Biosciences Research Foundation

    lead INDUSTRY

Eligibility

Min Age
14 Years
Max Age
78 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07164482 on ClinicalTrials.gov