Long-Term Follow-Up of Transplanted Human Central Nervous System Stem Cells (HuCNS-SC) in Spinal Cord Trauma Subjects

StemCells, Inc.12 enrolled

Overview

The purpose of this study is to determine the long term safety and preliminary efficacy of intramedullary transplantation of HuCNS-SC cells in subjects with thoracic spinal cord trauma.

The investigation is a multi-year observational study following the completion of the open-label, single dose Phase I/II study involving transplantation of allogeneic HuCNS-SC cells into 12 subjects with thoracic spinal cord injury. Subjects will be monitored at routine intervals for safety and preliminary efficacy for four years. The LTFU study will commence following the one year post-transplantation termination visit of the Phase I/II investigation.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Spinal Cord Injury

Interventions

ObservationOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Must have undergone HuCNS-SC transplantation as a subject in the Phase I/II trial * Must agree to comply in good faith with all conditions of the study and to attend all required study visits Exclusion Criteria: * Subjects have received or are receiving off-protocol immunosuppressive medications * Subjects who, after completion of Phase I/II trial (Protocol # CL-N02-SC), have entered or are about to enter any other investigational study.

Locations (1)

Uniklinik Balgrist

Zurich, Switzerland

Outcomes

Primary Outcomes

American Spinal Injury Association (ASIA) Impairment Scale Improvement

Evidence of improvement in ASIA impairment scale as confirmed by neurological examination

Time frame: Four years

Data from ClinicalTrials.gov

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