LTFU Study of Subjects Who Received GRNOPC1

NCT ID: NCT05919563

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-06

Study Completion Date

2026-12-12

Brief Summary

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This is a LTFU study for thoracic SCI subjects that were administered GRNOPC1 cells in the main study CP35A007.

Detailed Description

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Study CP35A008 is a Phase 1, multi-center long term follow-up (LTFU) study for five (5) subjects with complete thoracic SCI that were administered 2 million GRNOPC1 cells in the main study CP35A007. The purpose of this study is to monitor long-term safety in subjects for 15 years post GRNOPC1 administration.

Conditions

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Spinal Cord Injuries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects treated with GRNOPC1 in the initial dosing study CP35A007

Subjects treated with GRNOPC1 in the initial dosing study CP35A007 will be followed for 15-year long-term safety monitoring

Magnetic Resonance Imaging (MRI)

Intervention Type DIAGNOSTIC_TEST

Observational study; annual MRI for first 5 years only to monitor changes in the injection site

Interventions

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Magnetic Resonance Imaging (MRI)

Observational study; annual MRI for first 5 years only to monitor changes in the injection site

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Subjects who received administration of GRNOPC1 under clinical study protocol CP35A007.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lineage Cell Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gary Hogge, DVM, MS, PhD

Role: STUDY_CHAIR

Lineage Cell Therapeutics, Inc.

Locations

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Stanford University

Palo Alto, California, United States

Site Status

Shepherd Center

Atlanta, Georgia, United States

Site Status

Northwestern Medical Group

Evanston, Illinois, United States

Site Status

Countries

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United States

References

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McKenna SL, Ehsanian R, Liu CY, Steinberg GK, Jones L, Lebkowski JS, Wirth E, Fessler RG. Ten-year safety of pluripotent stem cell transplantation in acute thoracic spinal cord injury. J Neurosurg Spine. 2022 Apr 1;37(3):321-330. doi: 10.3171/2021.12.SPINE21622. Print 2022 Sep 1.

Reference Type RESULT
PMID: 35364569 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/35364569/

Ten-year safety of pluripotent stem cell transplantation in acute thoracic spinal cord injury

Other Identifiers

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CP35A008

Identifier Type: -

Identifier Source: org_study_id

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