Overview

This trial is active, not recruiting.

Condition spinal cord injury
Treatment autologous stem cell transplantation
Phase phase 1/phase 2
Sponsor Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
Collaborator Novagenesis Foundation
Start date July 2014
End date October 2018
Trial size 30 participants
Trial identifier NCT02326662, FMBA OPH1

Summary

This research investigates the use of autologous neural stem cells in patients with complete traumatic spinal cord injury.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Acute [1-6 mo.] patients (paraplegics) with major complete traumatic spinal cord injury that will undergo autologous neural stem cell transplantation including RMx Biomatrix as scaffold for the stem cells as needed Intervention: Autologous Stem Cell Transplantation with a 3D biomatrix.
autologous stem cell transplantation
Autologous neural stem cell transplantation Stem Cell Transplantation by intraspinal and intrathecal injection with 3D matrix as needed
(Experimental)
Sub-chronic [6-12 mo.] patients (paraplegics) with major complete traumatic spinal cord injury that will undergo autologous neural stem cell transplantation including RMx Biomatrix as scaffold for the stem cells as needed Intervention: Autologous Stem Cell Transplantation with a 3D biomatrix.
autologous stem cell transplantation
Autologous neural stem cell transplantation Stem Cell Transplantation by intraspinal and intrathecal injection with 3D matrix as needed
(Experimental)
Chronic [1- 5 years]) patients (paraplegics) with major complete traumatic spinal cord injury that will undergo autologous neural stem cell transplantation including RMx Biomatrix as scaffold for the stem cells as needed. Intervention: Autologous Stem Cell Transplantation with a 3D biomatrix.
autologous stem cell transplantation
Autologous neural stem cell transplantation Stem Cell Transplantation by intraspinal and intrathecal injection with 3D matrix as needed
(Experimental)
Acute [1-6 mo.] patients (tetraplegics) with major complete traumatic spinal cord injury that will undergo autologous neural stem cell transplantation including RMx Biomatrix as scaffold for the stem cells as needed Intervention: Autologous Stem Cell Transplantation with a 3D biomatrix.
autologous stem cell transplantation
Autologous neural stem cell transplantation Stem Cell Transplantation by intraspinal and intrathecal injection with 3D matrix as needed
(Experimental)
sub-chronic [6-12 mo.] patients (tetraplegics) with complete traumatic spinal cord injury that will undergo autologous neural stem cell transplantation including RMx Biomatrix as scaffold for the stem cells as needed. Intervention: Autologous Stem Cell Transplantation with a 3D biomatrix.
autologous stem cell transplantation
Autologous neural stem cell transplantation Stem Cell Transplantation by intraspinal and intrathecal injection with 3D matrix as needed
(Experimental)
Chronic [1- 5 years]) patients (tetraplegics) with major complete traumatic spinal cord injury that will undergo autologous neural stem cell transplantation including RMx Biomatrix as scaffold for the stem cells Intervention: Autologous Stem Cell Transplantation & Biomatrix
autologous stem cell transplantation
Autologous neural stem cell transplantation Stem Cell Transplantation by intraspinal and intrathecal injection with 3D matrix as needed

Primary Outcomes

Measure
Feasibility and safety of autologous Neural Stem Cell transplantation in patients with complete traumatic spinal cord injury as measured by reported side effects and surgery procedure
time frame: 24 months

Secondary Outcomes

Measure
324-point ASIA and other scoring incl. muscle control and voluntary movement and improvement of sphincters control
time frame: 3, 6,12, 24 months and 3 year follow-up
MRI Scan of Spinal Cord
time frame: 3, 6,12, 24 months and 3 year follow-up

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

Inclusion Criteria: - Age between 18 and 50 years old - Traumatic spinal cord injury at the neck, thoracic or lumbar level - Classification ASIA A and B with no significant further improvement with physical therapy/rehabilitation - A score of less than 200 in the 324-point ASIA scale - Injury duration 1 month to 5 years Exclusion Criteria: - An advanced, severe, or unstable disease of any type that may interfere with primary and secondary variable evaluations, including any medical condition that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical or mental status of the patient to a significant degree or put the patient at special risk (e.g., severe liver or kidney disease, malignancies/cancer) - Immune system disorder or dysfunction - Any major/serious infections up to 2 months prior to inclusion - A disability that may prevent the patient from completing all study requirements (e.g., blindness, deafness, severe language difficulty) - A current diagnosis of active, uncontrolled peptic ulceration within the last three months - A current diagnosis of acute, severe, or unstable asthmatic conditions [e.g., severe chronic obstructive pulmonary disease (COPD)] - Participated in any other investigational trial within 4 weeks of initial screening and within 7 weeks of study entry - History of regular alcohol intake or drug abuse in the previous 3 months and not able to sustain from alcohol intake during the trial Cardiovascular - A current diagnosis of severe or unstable cardiovascular disease - A current diagnosis of sick-sinus syndrome or conduction deficits (e.g., sino-atrial block, second or third degree atrio-ventricular block) - A current diagnosis of uncontrolled atrial fibrillation (>100 bpm) - A current diagnosis of moderate to severe heart failure [New York Heart Association (NYHA), Class III or more] - A myocardial infarction (MI) known to have occurred within the last 3 months - A current diagnosis of severe or unstable angina - Vital signs (supine) outside the following ranges - Systolic blood pressure below 90 or above 160 mmHg - Diastolic blood pressure below 55 or above 95 mmHg - Radial pulse below 50 or above 100 bpm CNS related - A recent history of up to one year or currently diagnosed with cerebrovascular disease (e.g., stroke transient ischemic attacks, aneurysms) - A current diagnosis of any primary neuro-degenerative disorder [e.g., Huntington's disease, Parkinson's disease etc.] - A current diagnosis of an active, uncontrolled seizure disorder Psychiatric - A current DSM-IV diagnosis of major depression - Any other DSM-IV Axis 1 diagnosis that may interfere with the response of the patient to study medication, including other primary degenerative dementia, schizophrenia, or bipolar disorder Laboratory abnormalities - Clinically significant abnormalities in routine laboratory examinations (hematology, electrolytes, biochemistry, liver and kidney function tests, urinanalysis) Concomitant therapy - Previous stem cell treatment - Ingested any of the following substances - An investigational drug during the past 6 months - A drug or treatment known to cause effect on the central nervous system [CNS] during the past four weeks - A drug or treatment known to cause major organ system toxicity during the past four weeks - Anticholinergic drugs at baseline - Medication for Parkinson's disease at baseline (e.g., selegiline, levodopa, amantadine, dopamine agonists, COMT inhibitors)

Additional Information

Official title Safety and Efficacy of Autologous Neural Stem Cell Transplantation in Patients With Traumatic Spinal Cord Injury
Principal investigator Alexander Averyanov, MD
Description The aim of this study is to evaluate Mesenchymal Stem Cells [MSC]-derived autologous neural stem cells transplantation as a safe and potentially beneficial treatment for patients with traumatic spinal cord injury.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Federal Research Clinical Center of Federal Medical & Biological Agency, Russia.