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A Study of Modified Stem Cells in Traumatic Brain Injury (TBI)

NCT02416492 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2021-12-27

Study results available
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Summary

The primary purpose of the clinical study is to evaluate the clinical efficacy of intracranial administration of SB623 cells on patients with chronic motor deficit from Traumatic Brain Injury. A secondary purpose of the study is 1) to evaluate the effect of intracranial administration of SB623 cells on disability parameters and 2) to evaluate the safety and tolerability of intracranial administration of SB623 cells. Patients with stable, chronic motor deficits secondary to focal traumatic brain injury must be 12 months post TBI.

Conditions

Interventions

BIOLOGICAL

SB623 cells

SB623 cells will be implanted in the peri-infarct area using stereotactic surgery.

PROCEDURE

Sham Control

Sham Surgery

Sponsors & Collaborators

  • SanBio, Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel C Lu, MD, PhD · University of California, Los Angeles, Department of Neurosurgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-06
Primary Completion
2019-01-31
Completion
2019-03-05

Countries

  • United States
  • Japan
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

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 NCT02416492 on ClinicalTrials.gov