Safety and Efficacy of SC0806 (Fibroblast Growth Factor 1 and a Device) in Traumatic Spinal Cord Injury Subjects
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02490501 |
Recruitment Status : Unknown
Verified January 2020 by BioArctic AB.
Recruitment status was: Active, not recruiting
First Posted : July 3, 2015
Last Update Posted : January 18, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Spinal Cord Injury | Procedure: SC0806 and rehabilitation Other: Rehabilitation only | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 27 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | June 2015 |
Estimated Primary Completion Date : | October 2020 |
Estimated Study Completion Date : | December 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: SC0806
Intervention with SC0806 (implantation of device with FGF1 and peripheral nerves) in addition to rehabilitation
|
Procedure: SC0806 and rehabilitation |
Controls
Rehabilitation only
|
Other: Rehabilitation only |
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02490501
Sweden | |
Karolinska University Hospital and RSS | |
Stockholm, Sweden |
Study Director: | Hans Basun, MD | BioArctic AB |
Responsible Party: | BioArctic AB |
ClinicalTrials.gov Identifier: | NCT02490501 |
Other Study ID Numbers: |
SC0806-A101 |
First Posted: | July 3, 2015 Key Record Dates |
Last Update Posted: | January 18, 2020 |
Last Verified: | January 2020 |
Spinal Cord Injuries Wounds and Injuries Spinal Cord Diseases |
Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System |