Efficacy Assessment of the Cell Therapy Medicine NC1 in Patients With Post-traumatic Syringomyelia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02807142
• Date of registration: 03/06/2016
• Prospective Registration: No
• Primary sponsor: Puerta de Hierro University Hospital
• Public title: Efficacy Assessment of the Cell Therapy Medicine NC1 in Patients With Post-traumatic Syringomyelia CME-LEM4
• Scientific title: Efficacy Assessment of the Cell Therapy Medicine NC1 in Patients With Post-traumatic Syringomyelia
• Date of first enrolment: March 2016
• Target sample size: 6
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02807142
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Contacts

• Name: Jesús Vaquero Crespo, M.D.
• Affiliation: Hospital Universitario Puerta de Hierro-Majadahonda

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with traumatic medullar injury (levels A, B, C or D of the ASIA scale) and
associated syringomyelia in at least three spinal segments, and with neurological
deficit clinically stable at least 6 months prior to treatment.

- Previous studies in Neurophysiology, MR, Urology (if data on neurogenic bowel exists),
defecatory function (if data on neurogenic intestine exists)

- Age between 18 and 70 years old.

- Presence of syringomyelia based on a neuro-image (MR)

- Patients will compromise to use anticonceptive measures from the cell extraction until
6 months after the administration of the treatment.

- Patients will compromise to a clinical follow-up and to perform physical therapy, one
hour daily five days per week during the treatment period.

- Patients should sign an written informed consent.

- Haematological and creatinin parameters, SGOT and SGPT into the normal ranges.

Exclusion Criteria:

- Patients under 18 or above 70 years old

- Pregnancy or breastfeeding

- Neoplasia in the last 5 years

- Patients with systemic diseases that increase the risk of the surgical intervention

- Genetics alterations that could conduct to cellular transformation during the cellular
expansion phase.

- Patients not really sure of their cooperation to follow the physical therapy or
clinical controls during the study.

- Additional neurodegenerative diseases

- Drug consuming, psychiatric disease or allergy to proteins used during cellular
expansion

- HIV or syphilis positive serologies

- Active Hepatitis B or c, based on serologies

- Any other reasons according to the investigator criteria.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Post-Traumatic Syringomyelia

Intervention(s)

Biological: NC 1 cell therapy

Primary Outcome(s)

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 [Time Frame: Pretreatment, month 3 post treatment, month 6 post treatment]

Secondary Outcome(s)

Efficacy of the treatment with NC1 in terms of improvement of neurological sequelae in patients with post traumatic syringomyelia in terms of defecatory function [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 assessed with the 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 studying the spinal cord morphology [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 [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 [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 [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 [Time Frame: Pretreatment, month 3 post treatment, month 6 post treatment]

Safety, by the assessment of the adverse events of the study [Time Frame: 1 year]

Efficacy of the treatment with NC1 in terms of improvement of neurological sequelae in patients with post traumatic syringomyelia in terms of spams frequency [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 [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 [Time Frame: Pretreatment, month 3 post treatment, month 6 post treatment]

Secondary ID(s)

CME-LEM4

Source(s) of Monetary Support

Please refer to primary and secondary sponsors