A Phase 2 interventional study of NC 1 cell therapy in Post-Traumatic Syringomyelia, sponsored by Puerta de Hierro University Hospital. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-04-05.
Sponsored by Puerta de Hierro University Hospital · Phase 2, Interventional, and Treatment
The objective of the study is to determine if the cell therapy NC1 administered in the spinal cord is effective for the treatment of a post-traumatic syringomyelia. The post-traumatic syringomyelia is the development and progression of cyst filled with cerebrospinal fluid (CSF) within the spinal cord. The cell therapy NC1 consist on cells obtained from the bone marrow of the patient, that are cultured in vitro and administered in the spinal cord of the same patient.
Phase II, Open, prospective, not controlled, not randomized clinical trial in patients affected by post-traumatic syringomyelia. The trial evaluates the efficacy of the cell therapy NC1 administered via intrathecal in the location of the injury. After the administration of the cell therapy, patients will undergo physiotherapy during the follow-up period (6 months). Patients will be evaluated at month 3 and month 6 after the NC1 administration.
Puerta de Hierro University Hospital is the lead sponsor of 48 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All patients will be treated with the same treatment: NC1 cell therapy
Biological: NC 1 cell therapy
All patients will be treated with NC1
Efficacy of the treatment with NC1 in terms of improvement of neurological sequelae in patients with post traumatic syringomyelia using the ASIA scale (American Spinal Injury Association
Neurological evaluation is done using ASIA scale (American Spinal Injury Association)
Time frame: Pretreatment, month 3 post treatment, month 6 post treatment
Safety, by the assessment of the adverse events of the study
Adverse events
Time frame: 1 year
Efficacy of the treatment with NC1 in terms of improvement of neurological sequelae in patients with post traumatic syringomyelia assessed with the IANR-SCIFRS scale (Injury Functional Rating Scale)
Neurological evaluation is done using IANR-SCIFRS scale (Injury Functional Rating Scale)
Time frame: Pretreatment, month 3 post treatment, month 6 post treatment
Efficacy of the treatment with NC1 in terms of improvement of neurological sequelae in patients with post traumatic syringomyelia in terms of spams frequency
Neurological evaluation is done using PENN scale (spams frequency score)
Time frame: Pretreatment, month 3 post treatment, month 6 post treatment
Efficacy of the treatment with NC1 in terms of improvement of neurological sequelae in patients with post traumatic syringomyelia in term of spasticity
Neurological evaluation is done using Ashworth scale (spasticity)
Time frame: Pretreatment, month 3 post treatment, month 6 post treatment
Efficacy of the treatment with NC1 in terms of improvement of neurological sequelae in patients with post traumatic syringomyelia using the Visual Analog Scale
Neurological evaluation is done using EVA scale (Visual Analog Scale)
Time frame: Pretreatment, month 3 post treatment, month 6 post treatment
Efficacy of the treatment with NC1 in terms of improvement of neurological sequelae in patients with post traumatic syringomyelia in terms of bladder functionality
Neurological evaluation is done using GEFFNER scale (bladder functionality)
Time frame: Pretreatment, month 3 post treatment, month 6 post treatment
Efficacy of the treatment with NC1 in terms of improvement of neurological sequelae in patients with post traumatic syringomyelia using the Behavior Dimensions Scale
Neurological evaluation is done using BDS scales (Behavior Dimensions Scale)
Time frame: Pretreatment, month 3 post treatment, month 6 post treatment
Efficacy of the treatment with NC1 in terms of improvement of neurological sequelae in patients with post traumatic syringomyelia in terms of somatosensory or motor evoked potentials
Present of somatosensory or motor evoked potentials
Time frame: Pretreatment, month 3 post treatment, month 6 post treatment
Efficacy of the treatment with NC1 in terms of improvement of neurological sequelae in patients with post traumatic syringomyelia by electromyography
EMG (Electromyography)
Time frame: Pretreatment, month 3 post treatment, month 6 post treatment
Efficacy of the treatment with NC1 in terms of improvement of neurological sequelae in patients with post traumatic syringomyelia studying the spinal cord morphology
Spinal cord morphology (by Magnetic Resonance)
Time frame: Pretreatment, month 3 post treatment, month 6 post treatment
Efficacy of the treatment with NC1 in terms of improvement of neurological sequelae in patients with post traumatic syringomyelia in terms of defecatory function
Neurological evaluation is done assessing the defecatory function
Time frame: Pretreatment, month 3 post treatment, month 6 post treatment
No study locations are listed for this record.
Plan to share: Yes — Anonymized individual data of participants will be shared with Authorities at the end of the Clinical Development Plan by the CTD (Common Technical Document). Results will be published in a scientific publication.
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Syringomyelia
Puerta de Hierro University Hospital