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Autoantibodies on Spinal Cord Injury

Role of Autoantibodies in Spontaneous Functional Recovery After Spinal Cord Injury

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02493543
Enrollment
110
Registered
2015-07-09
Start date
2014-10-17
Completion date
2018-04-30
Last updated
2018-02-23

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

Conditions

Spinal Cord Injuries

Keywords

autoantibodies

Brief summary

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

Detailed 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.

Interventions

OTHERBlood collection

Blood collection from the subject's arm

Sponsors

Fundación Mutua Madrileña
CollaboratorOTHER
Hospital Nacional de Parapléjicos de Toledo
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Changes in ASIA scores4 months

Secondary

MeasureTime frame
Change in neurological level of injury4 months
Change in ASIA impairment scale (AIS)4 months

Other

MeasureTime frame
Spinal cord independence measure (SCIM)Until discharge from the hospital (6-12 months)

Countries

Germany, Spain

Outcome results

None listed

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