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Trial record 1 of 1 for:    NCT02490501
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Safety and Efficacy of SC0806 (Fibroblast Growth Factor 1 and a Device) in Traumatic Spinal Cord Injury Subjects

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ClinicalTrials.gov Identifier: NCT02490501
Recruitment Status : Active, not recruiting
First Posted : July 3, 2015
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
European Commission
Information provided by (Responsible Party):
BioArctic AB

Tracking Information
First Submitted Date  ICMJE June 30, 2015
First Posted Date  ICMJE July 3, 2015
Last Update Posted Date January 18, 2020
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2015)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of SC0806 (Fibroblast Growth Factor 1 and a Device) in Traumatic Spinal Cord Injury Subjects
Official Title  ICMJE 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
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injury
Intervention  ICMJE
  • Procedure: SC0806 and rehabilitation
  • Other: Rehabilitation only
Study Arms  ICMJE
  • Active Comparator: SC0806
    Intervention with SC0806 (implantation of device with FGF1 and peripheral nerves) in addition to rehabilitation
    Intervention: Procedure: SC0806 and rehabilitation
  • Controls
    Rehabilitation only
    Intervention: Other: Rehabilitation only
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 2, 2015)
27
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02490501
Other Study ID Numbers  ICMJE SC0806-A101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party BioArctic AB
Study Sponsor  ICMJE BioArctic AB
Collaborators  ICMJE European Commission
Investigators  ICMJE
Study Director: Hans Basun, MD BioArctic AB
PRS Account BioArctic AB
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP