CompletedPhase 2

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

6 participantsStarted 2016-03

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Pretreatment, month 3 post treatment, month 6 post treatment

Trial details

NCT IDNCT02807142

SponsorPuerta de Hierro University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-02-07

View on ClinicalTrials.gov More Post-Traumatic Syringomyelia trials