Could a biodegradable device help heal spinal cords?
NCT ID NCT02490501
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-phase trial tested a device called SC0806, which is surgically implanted into the spine. It releases a growth factor to encourage nerve repair in people with complete spinal cord injury. Ten participants were randomly assigned to receive either the device plus rehabilitation or rehabilitation alone. The study looked at safety and whether the device could improve nerve signals.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SC0806 (a biodegradable device containing heparin-activated recombinant fibroblast growth factor 1 and nerve implants)
- What this could lead to
- If successful, this could point toward a new treatment to help restore some nerve function after spinal cord injury.
- What could go wrong
- This is an early, small trial (10 people) focused on safety. It may not show meaningful improvement, and the surgery carries risks like infection or device complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
10 people
The number who actually took part.
- Start date
-
Jun 2015
- Finished
-
May 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Traumatic Spinal Cord Injury. 2. Male or female subjects aged between 18 and 65 years. 3. BMI ≤35, body weight ≤125 kg and height ≤ 195 cm at Screening. 4. Complete SCI (ASIA Impairment Scale level A, no voluntary bladder function, negative motor and sensory evoked potentials). 5. A single spinal cord lesion injury at the neurologic level between T2-T11. 6. A Baseline MRI that indicates a pathology consistent with a traumatic SCI 7. 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. 8. Females must not be lactating or pregnant at Screening and Baseline (as documented by pregnancy tests). 9. 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). 10. 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. 11. Written informed consent obtained prior to any study specific procedures. 12. Eligible for surgery and specific walking training as judged by the investigator. Exclusion Criteria: 1. Other life-threatening injury. 2. Serious co-existing medical condition or mental disorder. 3. Results from neurophysiological examination preoperatively are inconsistent with a spinal cord injury of one thoracic segment or less. 4. 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. 5. Known hypersensitivity to FGF1 or heparin. 6. 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. 7. Ongoing drug or alcohol abuse or dependence. 8. Positive serology for Hepatitis B or C, or Human Immunodeficiency Virus (HIV) at Screening. 9. Positive test for Methicillin-resistent Staphylococcus Aureus (MRSA) at screening. 10. Any disease, concomitant injury, condition or treatment that interferes with the specific walking training, the performance or interpretation of the neurological examination. 11. Has a condition or has received medical treatment that, in the judgment of the investigator, precludes successful participation in the study. 12. Previous radiation treatment (e.g. cancer treatment) in the region of the spinal cord injury.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Karolinska University Hospital and RSS
Stockholm, Sweden
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Other studies related to the condition(s) this trial covers.
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