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Safety of Autologous Human Schwann Cells (ahSC) in Subjects With Subacute SCI

NCT01739023 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2019-03-05

No results posted yet for this study

Summary

The purpose of this study is to assess the safety of autologous human Schwann cells (ahSC) transplantation in subjects with subacute SCI.

For humans with subacute SCI, we hypothesize that axons might show improved function if myelin repair is induced with the implantation of ahSC. In addition spinal cord cavitation may be reduced, and neural sprouting and plasticity may be enhanced via neurotrophic effects.

Conditions

  • Spinal Cord Injury
  • Paraplegia

Interventions

BIOLOGICAL

Autologous Human Schwann Cells

Schwann cells harvested from the sural nerve of the participant will be autologously transplanted into the epicenter of the participant's spinal cord injury.

Sponsors & Collaborators

  • The Miami Project to Cure Paralysis

    collaborator OTHER

  • W. Dalton Dietrich

    lead OTHER

Principal Investigators

  • Dalton Dietrich, PhD · University of Miami

  • Allan Levi, MD, PhD · University of Miami

  • James Guest, MD, PhD · University of Miami

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01739023 on ClinicalTrials.gov