An Open, Randomized, Rehabilitation-controlled Study to Assess Safety, Tolerability, and Efficacy of Heparin Activated Recombinant Human Fibroblast Growth Factor 1 on a Biodegradable Device in Subjects with Traumatic Spinal Cord Injury

• Register: EUCTR
• Last refreshed on: 9 November 2020
• Main ID: EUCTR2013-000906-52-EE
• Date of registration: 11/12/2017
• Prospective Registration: Yes
• Primary sponsor: BioArctic AB
• Public title: An Open, Randomized, Rehabilitation-controlled Study to Assess Safety, Tolerability, and Efficacy of Heparin Activated Recombinant Human Fibroblast Growth Factor 1 on a Biodegradable Device in Subjects with Traumatic Spinal Cord Injury
• Scientific title: An Open, Randomized, Rehabilitation-controlled Study to Assess Safety, Tolerability, and Efficacy of Heparin Activated Recombinant Human Fibroblast Growth Factor 1 on a Biodegradable Device in Subjects with Traumatic Spinal Cord Injury
• Date of first enrolment: 16/01/2018
• Target sample size: 45
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000906-52
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Rehabilitation only, no treatment Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Estonia, Finland, Sweden

Contacts

• Name: Clinical trials information
• Affiliation: BioArctic AB

• Name: Clinical trials information
• Affiliation: BioArctic AB

Key inclusion & exclusion criteria

Inclusion criteria:
1.Traumatic Spinal Cord Injury
2. Male or female subjects aged between 18 and 65 years.
3. Body Mass Index (BMI) =35, body weight =125 kg and height = 195 cm at Screening.
4. Complete spinal cord injury (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 as judged from the MRI assessment.
8. Females must not be lactating or pregnant at Screening or Baseline (as documented by negative pregnancy tests).
9. All females that are 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 a double-barrier 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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-resistant 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Complete Traumatic Spinal Cord Injury (TSCI)

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Product Name: Heparin-activated recombinant human Fibroblast Growth Factor 1 (rhFGF1) with diluent and SCI-device
Product Code: SC0806
Pharmaceutical Form: Implant

Primary Outcome(s)

Primary end point(s): Primary 1:
• adverse events (AEs/ADEs) and serious adverse events (SAEs/SADEs)
• clinical significant changes of hematology, blood chemistry, and urine values
• vital signs, i.e. clinical significant changes in
o systolic and diastolic blood pressure
o heart rate (beats per minute)
o body temperature
o respiratory rate (rate per minute)
• electrocardiograms (ECGs)
• CT of device area
• MRI
• clinical significant changes on physical examinations
Primary 2:
• Proportion of subjects with an improvement, from baseline to 18 months in the Motor Evoked Potential (MEP) scores

Timepoint(s) of evaluation of this end point: From baseline to 18 months

Main Objective: • To assess the safety and tolerability of one implantation of SC0806 in subjects with complete Traumatic Spinal Cord Injury.
• To assess the efficacy of one implantation of SC0806 on Electrophysiology (MEP) in subjects with complete Traumatic Spinal Cord Injury.

Secondary Objective: To evaluate/assess
• plasma concentrations of FGF1
• changes of the neurological classification
• motor function
• effect of specific walking training
• functional improvements
• pain scores
• urinary function
• Quality of Life
• Immunogenicity (anti-FGF1 antibody)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: From baseline to Final Visit

Secondary end point(s): Secondary 1:
• FGF1 plasma concentration
Secondary 2:
• Change from baseline to Final Visit in the American Spinal Injury Association Impairment Scale (AIS) regarding neurological classification (grades)
Secondary 3:
• Change from baseline to Final Visit in the American Spinal Injury Association Impairment Scale (AIS) regarding motor function (motor score)
Secondary 4:
• Specific walking training: change from baseline to Final Visit in
o L-Force: (measures the isometric power (Nm) generated by the subject in a static position)
o L-Stiff: (measures the mechanical stiffness (Nm/degrees) in the joints of the subject (hip and knee) while the legs are led in a passive movement.)
• L-ROM: (measures the passive movement pattern (degrees) of the subject for flexion and extension in the hip and knee joints)
Secondary 5:
• Change from baseline to Final Visit in the Spinal Cord Independence Measure (SCIM)
Secondary 6:
• Change from baseline to Final Visit in the Graded Chronic Pain (GCP) Disability Scale
Secondary 7:
• Change from baseline to Final Visit in the following urodynamic variables
o Free flow
o Residual volume after micturition
o Cystometry (bladder capacity, sense of bladder filling and bladder pressure)
o Pressure flow (bladder pressure required to urinate and the flow rate a given pressure generates)
o Urethral pressure
o Ice-water test (presence of undesired bladder activity)
• Urine and leakage measurements (mean values from measurements on two separate days
Secondary 8:
• Change from baseline to Final Visit in the SCI-QoL assessment scale
• Change from baseline to Final Visit in the I-QoL assessment
• Change from baseline to Final Visit in the ICIQ-SF assessment scale
Secondary 9:
• Anti-FGF1 concentrations
Secondary 10:
• Proportion of subjects with an improvement, from baseline to Final Visit in the Motor Evoked Potential (MEP) scores

Secondary ID(s)

2013-000906-52-SE

SC0806-A101

Source(s) of Monetary Support

BioArctic AB

Ethics review

Status: Approved
Approval date: 16/11/2017
Contact: