Spinal Cord InjuryPhase 1/2NCT02490501
Safety and Efficacy of SC0806 (Fibroblast Growth Factor 1 and a Device) in Traumatic Spinal Cord Injury Subjects
A Phase 1/2 study testing SC0806 and rehabilitation and Rehabilitation only in people with Spinal Cord Injury, run by BioArctic AB at 1 site in Sweden.
Trial summary
This is an open, randomized, rehabilitation-controlled study in subjects with complete Traumatic Spinal Cord Injury, where the active treatment consists of a surgical implantation of SC0806 (a biodegradable device with heparin-activated FGF1 and nerve implants). 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?
- SC0806 and rehabilitation and Rehabilitation only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2015to May 2025
- Phase
- Phase 1/2
- 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
Who may be able to join
- Traumatic Spinal Cord Injury.
- Male or female subjects aged between 18 and 65 years.
- BMI ≤35, body weight ≤125 kg and height ≤ 195 cm at Screening.
- Complete SCI (ASIA Impairment Scale level A, no voluntary bladder function, negative motor and sensory evoked potentials).
- A single spinal cord lesion injury at the neurologic level between T2-T11.
- A Baseline MRI that indicates a pathology consistent with a traumatic SCI
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- Minimum of 4 months and maximum 10 years post injury with no evidence of neurological improvement prior to implantation surgery unless there is a complete anatomical cut-off of the spinal cord.
- Females must not be lactating or pregnant at Screening and Baseline (as documented by pregnancy tests).
- All females that are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
- Females of childbearing potential must not have had unprotected sexual intercourse within 30 days before study entry and must agree to use a highly effective method of contraception (e.g., total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period. If currently abstinent, the subject must agree to use an effective method as described above if she becomes sexually active during the study period. Females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and must continue to use the same contraceptive during the study.
- Written informed consent obtained prior to any study specific procedures.
- Eligible for surgery and specific walking training as judged by the investigator.
Who cannot join
- Other life-threatening injury.
- Serious co-existing medical condition or mental disorder.
- Results from neurophysiological examination preoperatively are inconsistent with a spinal cord injury of one thoracic segment or less.
- Current or prior (within the past 8 weeks or within 5 half-lives of use of such a medication prior to screening) participation in any other investigational medication or device trial.
- Known hypersensitivity to FGF1 or heparin.
- Subjects unable to tolerate or undergo MRI scanning, including subjects with claustrophobia unless sedation can be used, cardiac pacemaker/defibrillator, ferromagnetic metal implants e.g., in skull, cardiac devices, other than those approved as safe for use in MR scanners.
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- Ongoing drug or alcohol abuse or dependence.
- Positive serology for Hepatitis B or C, or Human Immunodeficiency Virus (HIV) at Screening.
- Positive test for Methicillin-resistent Staphylococcus Aureus (MRSA) at screening.
- Any disease, concomitant injury, condition or treatment that interferes with the specific walking training, the performance or interpretation of the neurological examination.
- Has a condition or has received medical treatment that, in the judgment of the investigator, precludes successful participation in the study.
- Previous radiation treatment (e.g. cancer treatment) in the region of the spinal cord injury.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Randomized, Rehabilitation-controlled Study to Assess Safety, Tolerability, and Efficacy of Heparin Activated Recombinant Fibroblast Growth Factor 1 on a Biodegradable Device in Subjects With Traumatic Spinal Cord Injury
This is an open, randomized, rehabilitation-controlled study in subjects with complete Traumatic Spinal Cord Injury, where the active treatment consists of a surgical implantation of SC0806 (a biodegradable device with heparin-activated FGF1 and nerve implants).
Read the detailed description
The study is a single dose study in up to 3 sequences in subjects with complete Traumatic Spinal Cord Injury. In each sequence, 6 subjects will be randomized to a surgical procedure where SC0806 will be implanted into the spinal cord and receive specific walking training, and 3 subjects will be randomized to specific walking training only. Interim analyses of safety parameters will be performed. If a positive effect and no major safety concerns have been demonstrated after completion of all sequences, the control subjects will be given the opportunity to receive treatment with SC0806 after completion of their rehabilitation periods.
- Conditions
- Spinal Cord Injury
- Being tested
- SC0806 and rehabilitation, Rehabilitation only
- 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.
SC0806 and rehabilitationProcedure or surgery
Rehabilitation onlyOther
| Study group | Role | What they receive |
|---|---|---|
| SC0806 | Active comparator | Intervention with SC0806 (implantation of device with FGF1 and peripheral nerves) in addition to rehabilitation Receives: Procedure: SC0806 and rehabilitation |
| Controls | Other | Rehabilitation only Receives: Other: Rehabilitation only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with an Adverse Event
Measured: 0 - 18 months
Proportion of subjects with an improvement, in the Motor Evoked Potential (MEP) scores
Measured: 0 - 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2020
- Study completionMay 2025
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioArctic AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Commission
- Responsible party
- Sponsor
- Investigators
- Hans Basun, MD, Study director, BioArctic AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490501
- Sponsor's protocol ID
- SC0806-A101
- Status last verified
- Sep 2025
- First submitted
- 30 Jun 2015
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Randomized, Rehabilitation-controlled Study to Assess Safety, Tolerability, and Efficacy of Heparin Activated Recombinant Fibroblast Growth Factor 1 on a Biodegradable Device in Subjects With Traumatic Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02490501
- Acronym / sponsor ID
- SC0806-A101
- Conditions
- Spinal Cord Injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- BioArctic ABIndustry (pharma, biotech, devices)
- Collaborators
- European Commission
- Study start
- Jun 2015
- Primary completion
- Oct 2020 (actual)
- Study completion
- May 2025 (actual)
- First posted
- 3 Jul 2015 (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.
This is an open, randomized, rehabilitation-controlled study in subjects with complete Traumatic Spinal Cord Injury, where the active treatment consists of a surgical implantation of SC0806 (a biodegradable device with heparin-activated FGF1 and nerve implants).
Detailed description
The study is a single dose study in up to 3 sequences in subjects with complete Traumatic Spinal Cord Injury. In each sequence, 6 subjects will be randomized to a surgical procedure where SC0806 will be implanted into the spinal cord and receive specific walking training, and 3 subjects will be randomized to specific walking training only. Interim analyses of safety parameters will be performed. If a positive effect and no major safety concerns have been demonstrated after completion of all sequences, the control subjects will be given the opportunity to receive treatment with SC0806 after completion of their rehabilitation periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SC0806 | Active comparator | Procedure: SC0806 and rehabilitationIntervention with SC0806 (implantation of device with FGF1 and peripheral nerves) in addition to rehabilitation |
| Controls | Other | Other: Rehabilitation onlyRehabilitation only |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Traumatic Spinal Cord Injury.
- Male or female subjects aged between 18 and 65 years.
- BMI ≤35, body weight ≤125 kg and height ≤ 195 cm at Screening.
- Complete SCI (ASIA Impairment Scale level A, no voluntary bladder function, negative motor and sensory evoked potentials).
- A single spinal cord lesion injury at the neurologic level between T2-T11.
Key exclusion criteria (12 listed)
- Other life-threatening injury.
- Serious co-existing medical condition or mental disorder.
- Results from neurophysiological examination preoperatively are inconsistent with a spinal cord injury of one thoracic segment or less.
- Current or prior (within the past 8 weeks or within 5 half-lives of use of such a medication prior to screening) participation in any other investigational medication or device trial.
- Known hypersensitivity to FGF1 or heparin.
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 |
|---|---|---|
| SC0806 and rehabilitation | Procedure or surgery | SC0806 |
| Rehabilitation only | Other | Controls |
Primary outcome
Proportion of subjects with an Adverse Event
Time frame: 0 - 18 months
Proportion of subjects with an improvement, in the Motor Evoked Potential (MEP) scores
Time frame: 0 - 18 months
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 22 Sep 2025.
- Homepage of sponsorLink provided by the sponsor.
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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.
Hans Basun, MD study director
BioArctic AB
1 site 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 SC0806 and rehabilitation and Rehabilitation only in people with Spinal Cord Injury, run by BioArctic AB at 1 site in Sweden.
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 12 inclusion and 12 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: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
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?
Proportion of subjects with an Adverse Event (time frame: 0 - 18 months). The study lists 2 primary outcomes in all. 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 22 Sep 2025.