Safety and Efficacy of SC0806 (Fibroblast Growth Factor 1 and a Device) in Traumatic Spinal Cord Injury Subjects

NCT02490501 | Completed Phase 1 DMC

• 1 other identifier: SC0806-A101
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (2)

• Proportion of subjects with an Adverse Event

  0 - 18 months

• Proportion of subjects with an improvement, in the Motor Evoked Potential (MEP) scores

  0 - 18 months

Study Arms (2)

SC0806

ACTIVE COMPARATOR

Intervention with SC0806 (implantation of device with FGF1 and peripheral nerves) in addition to rehabilitation

Procedure: SC0806 and rehabilitation

Controls

OTHER

Rehabilitation only

Other: Rehabilitation only

Interventions

SC0806 and rehabilitation PROCEDURE

SC0806

Rehabilitation only OTHER

Controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioArctic AB: lead
• European Commission: collaborator

Study Sites (1)

Karolinska University Hospital and RSS

Stockholm, Sweden

Location

Related Links

• Homepage of sponsor

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Hans Basun, MD

  BioArctic AB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2015
• First Posted: July 3, 2015
• Study Start: June 1, 2015
• Primary Completion: October 1, 2020
• Study Completion: May 1, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

SE (1)