Overview

This trial is active, not recruiting.

Condition post-traumatic syringomyelia
Treatment nc 1 cell therapy
Phase phase 2
Sponsor Puerta de Hierro University Hospital
Start date March 2016
End date March 2017
Trial size 6 participants
Trial identifier NCT02807142, CME-LEM4

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
All patients will be treated with the same treatment: NC1 cell therapy
nc 1 cell therapy
All patients will be treated with NC1

Primary Outcomes

Measure
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
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 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 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 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 in terms of 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
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 by 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
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
time frame: Pretreatment, month 3 post treatment, month 6 post treatment

Secondary Outcomes

Measure
Safety, by the assessment of the adverse events of the study
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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.

Additional Information

Official title Efficacy Assessment of the Cell Therapy Medicine NC1 in Patients With Post-traumatic Syringomyelia
Principal investigator Jesús Vaquero Crespo, M.D.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Puerta de Hierro University Hospital.