Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for TBI

Sponsor
The Foundation for Orthopaedics and Regenerative Medicine
Study ID
NCT05018832
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • AlloRx — BIOLOGICAL
    cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Study Details

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of traumatic brain injury

Key Dates

First listed
Aug 24, 2021
Start date
Dec 31, 2025
Status verified
Apr 2025
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Group (AlloRx)
    Single intravenous infusion of 100 million cells

Primary Outcome Measure

Safety (adverse events) [ Time Frame: Four year follow-up ]

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