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Clinical Trials/NCT02807142
NCT02807142CompletedPhase 2

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

Puerta de Hierro University Hospital0 sites6 target enrollmentStarted: March 1, 2016Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
6
Primary Endpoint
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
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

NC 1 cell therapy

Experimental

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

Intervention: NC 1 cell therapy (Biological)

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

Time Frame: Pretreatment, month 3 post treatment, month 6 post treatment

Neurological evaluation is done using ASIA scale (American Spinal Injury Association)

Secondary Outcomes

  • Efficacy of the treatment with NC1 in terms of improvement of neurological sequelae in patients with post traumatic syringomyelia in terms of spams frequency(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)(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(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(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(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(Pretreatment, month 3 post treatment, month 6 post treatment)
  • Safety, by the assessment of the adverse events of the study(1 year)
  • Efficacy of the treatment with NC1 in terms of improvement of neurological sequelae in patients with post traumatic syringomyelia using the Behavior Dimensions Scale(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(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(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(Pretreatment, month 3 post treatment, month 6 post treatment)

Investigators

Sponsor
Puerta de Hierro University Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jesús Vaquero Crespo, M.D.

M.D.

Puerta de Hierro University Hospital

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