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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 : Recruiting
First Posted : July 3, 2015
Last Update Posted : November 27, 2017
Sponsor:
Collaborator:
European Commission
Information provided by (Responsible Party):
BioArctic AB

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).

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Procedure: SC0806 and rehabilitation Other: Rehabilitation only Phase 1 Phase 2

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 : 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 : December 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Proportion of subjects with an Adverse Event [ Time Frame: 0 - 18 months ]
  2. Proportion of subjects with an improvement, in the Motor Evoked Potential (MEP) scores [ Time Frame: 0 - 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Hans Basun, MD +46734411798 hans.basun@bioarctic.se

Locations
Sweden
Karolinska University Hospital and RSS Recruiting
Stockholm, Sweden
Sponsors and Collaborators
BioArctic AB
European Commission
Investigators
Study Director: Hans Basun, MD BioArctic AB

Additional Information:
Responsible Party: BioArctic AB
ClinicalTrials.gov Identifier: NCT02490501     History of Changes
Other Study ID Numbers: SC0806-A101
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action