Spinal Cord InjuryPhase 1NCT01217008
Safety Study of GRNOPC1 in Spinal Cord Injury
A Phase 1 study testing GRNOPC1 in people with Spinal Cord Injury, run by Lineage Cell Therapeutics, Inc. at 7 sites in United States.
Trial summary
The purpose of the study is to evaluate the safety of GRNOPC1 administered at a single time-point between 7 and 14 days post injury, inclusive, to patients with neurologically complete spinal cord injuries (SCI). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- GRNOPC1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 7 sitesUnited States
- Study dates
- Oct 2010to Jul 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Major Inclusion Criteria:
- Neurologically complete, traumatic SCI (ASIA Impairment Scale A), zone of partial preservation < 5 levels
- Last fully preserved neurological level from T-3 through T-11
- From 18 through 65 years of age at time of injury
- Single spinal cord lesion
- 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 11 days following injury
- Able to participate in an elective surgical procedure to inject GRNOPC1 7-14 days following SCI
Major Exclusion Criteria:
- SCI due to penetrating trauma
- Traumatic anatomical transection or laceration of the spinal cord
- Any concomitant injury or pre-existing condition that interferes with the performance, interpretation or validity of neurological examinations
- Inability to communicate effectively with neurological examiner
- Significant organ damage or systemic disease that would create an unacceptable risk for surgery or immunosuppression
- History of any malignancy
- Pregnant or nursing women
- Body mass index (BMI) > 35 or weight > 300 lbs.
- Active participation in another experimental procedure/intervention
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Shepherd Center
Atlanta, Georgia, 30309
University of Maryland Medical Center/Kernan Orthopaedics and Rehabilitation Hospital
Baltimore, Maryland
University of Alabama at Birmingham
Birmingham, Alabama
Northwestern University
Chicago, Illinois, 60611
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Stanford University/Santa Clara Valley Medical Center
Palo Alto/San Jose, California
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania
About this study
Official title: A Phase 1 Safety Study of GRNOPC1 in Patients With Neurologically Complete, Subacute, Spinal Cord Injury
The purpose of the study is to evaluate the safety of GRNOPC1 administered at a single time-point between 7 and 14 days post injury, inclusive, to patients with neurologically complete spinal cord injuries (SCI).
- Conditions
- Spinal Cord Injury
- Being tested
- GRNOPC1
- Keywords
- Spinal Cord Injury, GRNOPC1
- 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.
GRNOPC1Biological
One injection of 2 million GRNOPC1 cells.
| Study group | Role | What they receive |
|---|---|---|
| GRNOPC1 | Experimental | Subjects who receive an injection of GRNOPC1 Receives: Biological: GRNOPC1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
The primary endpoint is safety, as measured by the frequency and severity of adverse events within 1 year (365 days) of GRNOPC1 injection that are related to GRNOPC1, the injection procedure used to administer GRNOPC1, and/or the concomitant immunosuppression administered.
Measured: One year
Secondary outcomes (1)
Neurological function
The secondary endpoint is neurological function as measured by sensory scores and lower extremity motor scores on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examinations.
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 posted8 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lineage Cell Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217008
- Sponsor's protocol ID
- CP35A007
- Status last verified
- Jan 2014
- First submitted
- 6 Oct 2010
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Safety Study of GRNOPC1 in Patients With Neurologically Complete, Subacute, Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01217008
- Acronym / sponsor ID
- CP35A007
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal Cord Injury, GRNOPC1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Lineage Cell Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 8 Oct 2010 (estimated)
- 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.
The purpose of the study is to evaluate the safety of GRNOPC1 administered at a single time-point between 7 and 14 days post injury, inclusive, to patients with neurologically complete spinal cord injuries (SCI).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GRNOPC1 | Experimental | Biological: GRNOPC1Subjects who receive an injection of GRNOPC1 |
Who may qualify
- Ages
- 18 to 65 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 |
|---|---|---|
| GRNOPC1One injection of 2 million GRNOPC1 cells. | Biological | GRNOPC1 |
Primary outcome
Safety
Time frame: One year
The primary endpoint is safety, as measured by the frequency and severity of adverse events within 1 year (365 days) of GRNOPC1 injection that are related to GRNOPC1, the injection procedure used to administer GRNOPC1, and/or the concomitant immunosuppression administered.
1 secondary outcome
Neurological function
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GRNOPC1 in people with Spinal Cord Injury, run by Lineage Cell Therapeutics, Inc. at 7 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 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2020.