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

Puerta de Hierro University Hospital6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Post-Traumatic Syringomyelia

Interventions

NC 1 cell therapyBIOLOGICAL

All patients will be treated with NC1

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)

Data from ClinicalTrials.gov

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