Cervical Spinal Cord InjuryPhase 1/2NCT02302157
Dose Escalation Study of AST-OPC1 in Spinal Cord Injury
A Phase 1/2 study testing AST-OPC1 in people with Cervical Spinal Cord Injury and Spine Injury, run by Lineage Cell Therapeutics, Inc. at 9 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety of cross sequential escalating doses of AST-OPC1 administered among 5 cohorts at a single time-point between 21 and 42 days post injury, inclusively, to subjects with subacute cervical spinal cord injuries (SCI). Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Cervical Spinal Cord Injury, Spine Injury, Spinal Cord Trauma
- What is being tested?
- AST-OPC1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 9 sitesUnited States
- Study dates
- Mar 2015to Dec 2018
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Major Inclusion Criteria:
- Sensorimotor complete, traumatic SCI (ASIA Impairment Scale A) for cohorts 1,2,3
- Sensorimotor incomplete, traumatic SCI (ASIA Impairment Scale B) for cohorts 4,5
- Last fully preserved single neurological level (SNL) from C-4 to C-7
- From 18 through 69 years of age at time of injury
- Single spinal cord lesion on a post-stabilization magnetic resonance imaging (MRI) scan, with sufficient visualization of the spinal cord injury epicenter and lesion margins to enable post-injection safety monitoring
- Informed consent for this protocol and the companion long term follow-up protocol must be provided and documented (i.e., signed informed consent forms) no later than 37 days following injury
- Able to participate in an elective surgical procedure to inject AST-OPC1 21-42 days following SCI
Major Exclusion Criteria:
- SCI due to penetrating trauma
- Traumatic anatomical transection or laceration of the spinal cord based on prior surgery or MRI
- Any concomitant injury that interferes with the performance, interpretation or validity of neurological examinations
- Inability to communicate effectively with neurological examiner such that the validity of patient data could be compromised
- Significant organ damage or systemic disease that would create an unacceptable risk for surgery or immunosuppression
- History of any malignancy (except non-melanoma skin cancers)
- Pregnant or nursing women
- Body mass index (BMI) > 35 or weight > 300 lbs.
- Active participation in another experimental procedure/intervention
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Shepherd Center
Atlanta, Georgia, 30309
Rush University Medical Center
Chicago, Illinois, 60612
Indiana University
Indianapolis, Indiana, 46202
Univ. of California at San Diego
La Jolla, California, 92093
Rancho Los Amigos/USC
Los Angeles, California
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Thomas Jefferson University/Magee Rehabilitation
Philadelphia, Pennsylvania, 19107
Stanford University/Santa Clara Valley Medical Center
San Jose, California, 95128
Washington University
St Louis, Missouri, 63110
About this study
Official title: A Phase 1/2a Dose Escalation Study of AST-OPC1 in Subjects With Subacute Cervical Spinal Cord Injury
The purpose of this study is to evaluate the safety of cross sequential escalating doses of AST-OPC1 administered among 5 cohorts at a single time-point between 21 and 42 days post injury, inclusively, to subjects with subacute cervical spinal cord injuries (SCI).
- Being tested
- AST-OPC1
- Keywords
- Cervical spinal cord injury, AST-OPC1, SCiStar, OPC1, Neural cell, Trauma spinal cord, stemcell transplant, Cervical spine injury, Paralysis, Quadriplegia, Tetraplegia, Spine injury, oligodendrocyte progenitor cell, Subacute spinal cord injury
- Medical subject headings
- Spinal Injuries, Spinal Cord Injuries, Paralysis, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AST-OPC1Biological
One injection of 2 million or 10 million AST-OPC1 cells, or 2 injections of 10 million AST-OPC1 cells for a total of 20 million cells; cohort dependent
| Study group | Role | What they receive |
|---|---|---|
| AST-OPC1 | Experimental | Open label, dose escalation, cross-sequential cohort of subjects who receive an injection or two injections of AST-OPC1 at a single time-point Receives: Biological: AST-OPC1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events Within 1 Year (365 Days) That Are Related to AST-OPC1 Injection
Numbers of adverse events within 1 year (365 days) that are related to AST-OPC1 injection
Measured: One Year
Secondary outcomes (1)
Neurological Function as Measured by Upper Extremity Motor Scores and Motor Level on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examinations as Secondary End Point - 365 Days After Injection of AST-OPC1
The scale is based on the ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury) that measures the severity of Spinal cord injury. The data was collected per time point during the first year (30,60,90,180,270,365). The 365-days time point was pre-specified as Secondary Outcome Measure. High score means better outcome. Units are "Scores on a scale".
The score is divided to motor scale (0-100) and sensor scale (0-224).
Motor scale is divided to subscale of upper extremity (0-50) and lower extremity (0-50).
Upper and lower extremity are divided to subscale of Right (0-25) + Left (0-25).
Each upper \& lower extremity is divided to subscale of 5 motor nerve function (0-5).
Sensor scale is divided to subscale of light touch (0-112) and pin prick (0-112).
light touch and pin prick are divided to subscales of Right (0-56) + Left (0-56).
Each right and left light touch and pin prick are divided to subscales of 28 sensor nerve function (0-2)
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study startMar 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical Spinal Cord InjuryStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lineage Cell Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward D Wirth III, MD, PhD, Study director, Asterias Biotherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302157
- Sponsor's protocol ID
- AST-OPC1-01
- Status last verified
- Jun 2021
- First submitted
- 24 Nov 2014
- Last updated
- 14 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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 35901693McKenna 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.
PubMed 35364569
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a Dose Escalation Study of AST-OPC1 in Subjects With Subacute Cervical Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02302157
- Acronym / sponsor ID
- AST-OPC1-01
- Keywords
- Cervical spinal cord injury, AST-OPC1, SCiStar, OPC1, Neural cell, Trauma spinal cord, stemcell transplant, Cervical spine injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Lineage Cell Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 26 Nov 2014 (estimated)
- Results
- Posted 13 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety of cross sequential escalating doses of AST-OPC1 administered among 5 cohorts at a single time-point between 21 and 42 days post injury, inclusively, to subjects with subacute cervical spinal cord injuries (SCI).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AST-OPC1 | Experimental | Biological: AST-OPC1Open label, dose escalation, cross-sequential cohort of subjects who receive an injection or two injections of AST-OPC1 at a single time-point |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| AST-OPC1One injection of 2 million or 10 million AST-OPC1 cells, or 2 injections of 10 million AST-OPC1 cells for a total of 20 million cells; cohort dependent | Biological | AST-OPC1 |
Primary outcome
Number of Adverse Events Within 1 Year (365 Days) That Are Related to AST-OPC1 Injection
Time frame: One Year
Numbers of adverse events within 1 year (365 days) that are related to AST-OPC1 injection
1 secondary outcome
Neurological Function as Measured by Upper Extremity Motor Scores and Motor Level on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examinations as Secondary End Point - 365 Days After Injection of AST-OPC1
Time frame: One Year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: 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.
- Derived from this study: PubMed 35364569McKenna 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.
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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.
Edward D Wirth III, MD, PhD study director
Asterias Biotherapeutics
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AST-OPC1 in people with Cervical Spinal Cord Injury and Spine Injury, run by Lineage Cell Therapeutics, Inc. at 9 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?
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: finished, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Adverse Events Within 1 Year (365 Days) That Are Related to AST-OPC1 Injection (time frame: One Year). 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 NCT02302157, which also lists 2 linked publications.
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 14 Jul 2021.