Autoantibodies on Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:

Role of Autoantibodies in Spontaneous Functional Recovery After Spinal Cord Injury

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02493543
• Other study ID #: FMM14
• Status: Active, not recruiting
• Phase: N/A
• First received: July 7, 2015
• Last updated: February 22, 2018
• Start date: October 17, 2014
• Est. completion date: April 2018

Study information

• Verified date: February 2018
• Source: Hospital Nacional de Parapléjicos de Toledo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine the autoantibody profiles after spinal cord injury and their role in spontaneous functional recovery.

Description:

Most patients experience variable degrees of functional recovery after spinal cord injury (SCI), predominantly in the first months after lesion. In SCI animal models, autoantibodies are pathogenic and their titers rise up at the time when spontaneous recovery stops. The aim of this study is to determine the autoantibody profiles after SCI and to infer their relation with functional recovery. To achieve this, autoantibody profiles, biochemical, hematological and immune-related parameters (cytokines, chemokines and growth factors) will be determined from a serum blood sample and functional recovery will be evaluated accordingly to standardized scales.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Traumatic or non-progressive vascular SCI

• Less than 45 days after lesion

• Any neurological level

• Complete and incomplete lesions

• If patient has been treated with glucocorticoids, it should have passed at least 7 days from the end of the treatment

Exclusion Criteria:

• Cauda equina syndrome

• Autoimmune disorder

• Tumor (even if benign)

• Neurodegenerative disease

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Other:
• Blood collection
Blood collection from the subject's arm

Locations

Country	Name	City	State
Germany	Berufsgenossenschaftliche Unfallklinik Murnau	Murnau Am Staffelsee
Spain	Hospital Nacional de Parapléjicos, SESCAM	Toledo

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Nacional de Parapléjicos de Toledo	Fundación Mutua Madrileña

Countries where clinical trial is conducted

Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Spinal cord independence measure (SCIM)		Until discharge from the hospital (6-12 months)
Primary	Changes in ASIA scores		4 months
Secondary	Change in neurological level of injury		4 months
Secondary	Change in ASIA impairment scale (AIS)		4 months