Spinal Cord InjuriesNCT05975424
LTFU Study of Subjects With Cervical SCI Who Received AST-OPC1
An observational study of Spinal Cord Injuries, run by Lineage Cell Therapeutics, Inc. at 6 sites in United States.
Trial summary
This is a LTFU study for cervical SCI subjects that were administered AST-OPC1 cells in the main study AST-OPC1-01. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Magnetic Resonance Imaging (MRI)
- Type of treatment
- Injection or infusion
- How many people
- 25 participants
- Where
- 6 sitesUnited States
- Study dates
- 13 Jun 2018to 14 Jan 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who received administration of AST-OPC1 under clinical study protocol AST-OPC1-01
Who may be able to join
- Subjects who received AST-OPC1 under Study AST-OPC1-01
- Reconfirmation of consent for long-term follow-up
Who cannot join
- •Subjects who, for geographic or compliance reasons, are inappropriate candidates for participation in a long-term follow-up study in the opinion of the Investigator
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Shepherd Center
Atlanta, Georgia, 30309
RUSH University Medical Center
Chicago, Illinois, 60612
University of Southern California
Los Angeles, California, 90033
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Stanford University
Palo Alto, California, 94304
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Long-term Follow-up Study of Subjects With Cervical Spinal Cord Injuries Who Received AST-OPC1 in Protocol AST-OPC1-01
This is a LTFU study for cervical SCI subjects that were administered AST-OPC1 cells in the main study AST-OPC1-01.
Read the detailed description
Study AST-OPC1-02 is a Phase 1/2a open-label, multi-center long term follow-up (LTFU) study for twenty-five (25) subjects with cervical SCI that were administered AST-OPC1 cells in the main dose-escalation study AST-OPC1-01. The purpose of this study is to monitor long-term safety in subjects for 15 years post AST-OPC1 administration.
- Conditions
- Spinal Cord Injuries
- Being tested
- Magnetic Resonance Imaging (MRI)
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Diagnostic test
Observational study; annual MRI for first 5 years only to monitor changes in the injection site
| Study group | Role | What they receive |
|---|---|---|
| Subjects treated with AST-OPC1 in the initial dosing study AST-OPC1-01 | Subjects treated with AST-OPC1 in the initial dosing study AST-OPC1-01 will be followed for 15-year long-term safety monitoring Receives: Diagnostic Test: Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs)
Information will be collected on all adverse events through Year 5 and on late-occurring adverse events (Years 6-15) related to any changes in neurological condition, a fever of unknown etiology, and the development of neoplasias and/or neurological disorders.
Measured: Up to 15 years after AST-OPC1 injection
Changes from baseline greater than 1.5x or 2x in chemistry and hematology panel results over 5 years after injection of AST-OPC1
Summary statistics will be tabulated for chemistry and hematology laboratory parameter results and change from baseline to Year 5, as applicable, by cohort and overall. A table counting abnormal flags based on the respective lab's reference ranges by time point will be generated for each cohort and overall. At each visit, for each parameter, the number of subjects with low, normal, high, and clinically significant assessments will be tabulated.
Measured: Up to 5 years after AST-OPC1 injection
Changes at the injection site as monitored by MRI
MRI scans will monitor the brain and cervical spine for any possible long-term changes that could be related to AST-OPC1
Measured: Up to 5 years after AST-OPC1 injection
Secondary outcomes (1)
Changes in neurologic function as assessed by the ISNCSCI
Subject baseline results will be compared against changes in motor and sensory examination results
Measured: Up to 5 years after AST-OPC1 injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start13 Jun 2018
- Primary completion14 Jan 2033 (estimated)
- Study completion14 Jan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lineage Cell Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary Hogge, DVM, MS, PhD, Study chair, Lineage Cell Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975424
- Sponsor's protocol ID
- AST-OPC1-02
- Status last verified
- Aug 2024
- First submitted
- 24 May 2023
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fessler RG, Ehsanian R, Liu CY, Steinberg GK, Jones L, Lebkowski JS, Wirth ED, McKenna SL. A phase 1/2a dose-escalation study of oligodendrocyte progenitor cells in individuals with subacute cervical spinal cord injury. J Neurosurg Spine. 2022 Jul 8;37(6):812-820. doi: 10.3171/2022.5.SPINE22167. Print 2022 Dec 1.
PubMed 35901693
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Follow-up Study of Subjects With Cervical Spinal Cord Injuries Who Received AST-OPC1 in Protocol AST-OPC1-01
- ClinicalTrials.gov ID
- NCT05975424
- Acronym / sponsor ID
- AST-OPC1-02
- Conditions
- Spinal Cord Injuries
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Lineage Cell Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 14 Jan 2033 (estimated)
- Study completion
- 14 Jan 2033 (estimated)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a LTFU study for cervical SCI subjects that were administered AST-OPC1 cells in the main study AST-OPC1-01.
Detailed description
Study AST-OPC1-02 is a Phase 1/2a open-label, multi-center long term follow-up (LTFU) study for twenty-five (25) subjects with cervical SCI that were administered AST-OPC1 cells in the main dose-escalation study AST-OPC1-01. The purpose of this study is to monitor long-term safety in subjects for 15 years post AST-OPC1 administration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects treated with AST-OPC1 in the initial dosing study AST-OPC1-01 | – | Diagnostic Test: Magnetic Resonance Imaging (MRI)Subjects treated with AST-OPC1 in the initial dosing study AST-OPC1-01 will be followed for 15-year long-term safety monitoring |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who received administration of AST-OPC1 under clinical study protocol AST-OPC1-01
Key inclusion criteria (2 listed)
- Subjects who received AST-OPC1 under Study AST-OPC1-01
- Reconfirmation of consent for long-term follow-up
Key exclusion criteria (1 listed)
- •Subjects who, for geographic or compliance reasons, are inappropriate candidates for participation in a long-term follow-up study in the opinion of the Investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging (MRI)Observational study; annual MRI for first 5 years only to monitor changes in the injection site | Diagnostic test | Subjects treated with AST-OPC1 in the initial dosing study AST-OPC1-01 |
Primary outcome
Incidence and severity of adverse events (AEs)
Time frame: Up to 15 years after AST-OPC1 injection
Information will be collected on all adverse events through Year 5 and on late-occurring adverse events (Years 6-15) related to any changes in neurological condition, a fever of unknown etiology, and the development of neoplasias and/or neurological disorders.
Changes from baseline greater than 1.5x or 2x in chemistry and hematology panel results over 5 years after injection of AST-OPC1
Time frame: Up to 5 years after AST-OPC1 injection
Summary statistics will be tabulated for chemistry and hematology laboratory parameter results and change from baseline to Year 5, as applicable, by cohort and overall. A table counting abnormal flags based on the respective lab's reference ranges by time point will be generated for each cohort and overall. At each visit, for each parameter, the number of subjects with low, normal, high, and clinically significant assessments will be tabulated.
Changes at the injection site as monitored by MRI
Time frame: Up to 5 years after AST-OPC1 injection
MRI scans will monitor the brain and cervical spine for any possible long-term changes that could be related to AST-OPC1
1 secondary outcome
Changes in neurologic function as assessed by the ISNCSCI
Time frame: Up to 5 years after AST-OPC1 injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Results publication: PubMed 35901693Fessler RG, Ehsanian R, Liu CY, Steinberg GK, Jones L, Lebkowski JS, Wirth ED, McKenna SL. A phase 1/2a dose-escalation study of oligodendrocyte progenitor cells in individuals with subacute cervical spinal cord injury. J Neurosurg Spine. 2022 Jul 8;37(6):812-820. doi: 10.3171/2022.5.SPINE22167. Print 2022 Dec 1.
- A phase 1/2a dose-escalation study of oligodendrocyte progenitor cells in individuals with subacute cervical spinal cord injuryLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Hogge, DVM, MS, PhD study chair
Lineage Cell Therapeutics, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by Lineage Cell Therapeutics, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) (time frame: Up to 15 years after AST-OPC1 injection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05975424, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.