Efficacy Assessment of the Cell Therapy Medicine NC1 in Patients With Post-traumatic Syringomyelia (CME-LEM4)

Majadahonda Iron Gate University

Status and phase

Completed

Phase 2

Conditions

Post-Traumatic Syringomyelia

Treatments

Biological: NC 1 cell therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02807142

CME-LEM4

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.