Cethrin in Acute Cervical Spinal Cord Injury

A Phase II/III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Cethrin in Subjects With Acute Cervical Spinal Cord Injury

Status

Withdrawn

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02053883

Enrollment

Registered

2014-02-04

Start date

2015-07-31

Completion date

Unknown

Last updated

2014-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 62 Years

Healthy volunteers

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

* 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

Design outcomes

Primary

Measure	Time frame
American Spinal Injury Association (ASIA) Upper Extremity Motor Score Recovery	Baseline to 6 Months

Secondary

Measure	Time frame
ASIA Impairment Scale (AIS) Grade Recovery	Baseline to 6 Months
Motor Neurological Level Recovery	Baseline to 6 Months
ASIA Sensory Score Recovery	Baseline to 6 Months
ASIA Total Motor Score Recovery	Baseline to 6 Months
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)	6 Months
Incidence of Adverse Events	0-6 Months
Spinal Cord Independence Measure (SCIM) III (Total Score, Self-Care Subscore)	6 Months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026