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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-02-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Post-Traumatic Syringomyelia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NC 1 cell therapy

All patients will be treated with the same treatment: NC1 cell therapy

Group Type EXPERIMENTAL

NC 1 cell therapy

Intervention Type BIOLOGICAL

All patients will be treated with NC1

Interventions

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NC 1 cell therapy

All patients will be treated with NC1

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No