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The Safety of ahSC in Chronic SCI With Rehabilitation

NCT02354625 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-08-14

No results posted yet for this study

Summary

The purpose of this study is to assess the safety of autologous human Schwann cell (ahSC) transplantation in participants with chronic SCI.

This trial design is phase I, open label, unblinded, non-randomized, and non-placebo controlled multiple injury cohorts.

Conditions

  • Spinal Cord Injury
  • Paraplegia
  • Quadriplegia
  • Tetraplegia

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

  • 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
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2019-08-12
Completion
2019-08-12

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 NCT02354625 on ClinicalTrials.gov