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WithdrawnNCT02053883Updated Nov 26, 2014

Cethrin in Acute Cervical Spinal Cord Injury

A Phase 2/3 interventional study of Cethrin (BA-210) and Placebo in Spinal Cord Injury, sponsored by BioAxone BioSciences, Inc.. Withdrawn. Open to participants aged 18 Years to 62 Years. Per ClinicalTrials.gov, last updated 2014-11-26.

Sponsored by BioAxone BioSciences, Inc. · Phase 2/3, Interventional, and Treatment

Why this study was withdrawn
Compound recently partnered with another company for continued development.
Phase
Phase 2/3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 62 Years
Sex
All
01

Study summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase IIb/III study designed to evaluate the efficacy and safety of Cethrin as a treatment for acute cervical spinal cord injury. During the trial, high and low doses of Cethrin will be compared with placebo.

02

Conditions studied

  • Spinal Cord Injury

Keywords

  • SCI
  • spinal cord injury
  • biologic drug
  • rho
  • paralysis
  • paraplegia
  • tetraplegia
  • quadriplegia
  • trauma
  • central nervous system
  • fibrin sealant
  • neurosurgery
  • cervical
  • regeneration
  • neurotrauma
03

In context

Spinal Cord Injuries

1,988 studies on the registry are indexed under Spinal Cord Injuries; 516 are open to participants now.

Browse Spinal Cord Injuries studies →

Lead sponsor

BioAxone BioSciences, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 62 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Males or females, ages 18-62, inclusive
  • Acute cervical spinal cord injury at a neurological level of C4-C6
  • AIS Grade A or B
  • Scheduled to undergo decompression/stabilization surgery within five days of injury
  • Written or verbal consent from patient or legally authorized representative that patient is able and willing to comply with the study protocol, including follow-up visits

Exclusion criteria

Exclusion Criteria:

  • Participation in any other clinical trial for acute SCI, including previous Cethrin trial
  • Inability to receive study medication within five days of injury
  • Acute SCI from gunshot or penetrating/stab wound; peripheral nerve injury; brachial plexus injury; complete spinal cord transection; or multifocal SCI
  • Significant hemorrhage on MRI/CT scan
  • Females who are breastfeeding or have a positive serum pregnancy test
  • Body mass index (BMI) of ≥ 35 kg/m2 at screening
  • History of an adverse reaction to a fibrin sealant or its human or bovine components
  • Use of intravenous heparin in previous 48 hours, aspirin-containing products in previous 24 hours, thrombolytics in previous 12 hours
  • Hemophilia or other bleeding abnormality (platelet level lower than 100 X 109/L, activated partial thromboplastin time or international normalized ratio higher than the upper limit of normal, or baseline hematocrit lower than 0.25)
  • Unconsciousness or other impairment that precludes reliable ASIA examination
  • Known immunodeficiency, including human immunodeficiency virus, or use of immunosuppressive or cancer chemotherapeutic drugs
  • Clinically significant pre-existing neurological, cardiac, respiratory, hepatic, or renal disease
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Fibrin sealant only.

    Drug: Placebo

  • Experimental
    Cethrin (BA-210) - Low Dose

    Low dose of Cethrin in a fibrin sealant.

    Drug: Cethrin (BA-210)

  • Experimental
    Cethrin (BA-210) - High Dose

    High dose of Cethrin in a fibrin sealant.

    Drug: Cethrin (BA-210)

Interventions

  • DrugCethrin (BA-210)

    High or low doses of Cethrin administered extradurally in a fibrin sealant during spinal decompression/stabilization surgery.

  • DrugPlacebo

    Fibrin sealant alone administered extradurally during spinal decompression/stabilization surgery.

06

What researchers measure

Primary outcomes

  1. American Spinal Injury Association (ASIA) Upper Extremity Motor Score Recovery

    Time frame: Baseline to 6 Months

Secondary outcomes

  1. ASIA Total Motor Score Recovery

    Time frame: Baseline to 6 Months

  2. ASIA Impairment Scale (AIS) Grade Recovery

    Time frame: Baseline to 6 Months

  3. Motor Neurological Level Recovery

    Time frame: Baseline to 6 Months

  4. ASIA Sensory Score Recovery

    Time frame: Baseline to 6 Months

  5. Spinal Cord Independence Measure (SCIM) III (Total Score, Self-Care Subscore)

    Time frame: 6 Months

  6. Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)

    Time frame: 6 Months

  7. Incidence of Adverse Events

    Time frame: 0-6 Months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02053883
Lead sponsor
BioAxone BioSciences, Inc.
Responsible party
Sponsor
First posted
Feb 4, 2014
Start date
Jul 2015
Primary completion
May 2016 (estimated)
Last update
Nov 26, 2014
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Exoenzyme C3, Clostridium botulinum

Other studies in this condition

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Other studies from this sponsor

BioAxone BioSciences, Inc.

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