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Neural Stem Cell Transplantation in Traumatic Spinal Cord Injury

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02326662
First Posted: December 29, 2014
Last Update Posted: October 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Novagenesis Foundation
Ophiuchus Technologies AG
Information provided by (Responsible Party):
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
  Purpose
This research investigates the use of autologous neural stem cells in patients with complete traumatic spinal cord injury.

Condition Intervention Phase
Spinal Cord Injury Biological: Autologous Stem Cell Transplantation Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Autologous Neural Stem Cell Transplantation in Patients With Traumatic Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Federal Research Clinical Center of Federal Medical & Biological Agency, Russia:

Primary Outcome Measures:
  • 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 ]
    Side effects is recorded by the hospital staff, in the CRF and by the patient. Surgery procedure is documented by video and standard recording


Secondary Outcome Measures:
  • 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 ]
    Change from Baseline in ASIA Score. All patients are stable ASIA A.

  • MRI Scan of Spinal Cord [ Time Frame: 3, 6,12, 24 months and 3 year follow-up ]
    Change from Baseline of Injury Area. All patients has spinal cord injuries visible on MRI


Estimated Enrollment: 30
Study Start Date: July 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paraplegics Acute
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.
Biological: Autologous Stem Cell Transplantation
Autologous neural stem cell transplantation Stem Cell Transplantation by intraspinal and intrathecal injection with 3D matrix as needed
Experimental: Paraplegics Sub-chronic
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.
Biological: Autologous Stem Cell Transplantation
Autologous neural stem cell transplantation Stem Cell Transplantation by intraspinal and intrathecal injection with 3D matrix as needed
Experimental: Paraplegics Chronic

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.

Biological: Autologous Stem Cell Transplantation
Autologous neural stem cell transplantation Stem Cell Transplantation by intraspinal and intrathecal injection with 3D matrix as needed
Experimental: Tetraplegics Acute
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.
Biological: Autologous Stem Cell Transplantation
Autologous neural stem cell transplantation Stem Cell Transplantation by intraspinal and intrathecal injection with 3D matrix as needed
Experimental: Tetraplegics Sub-chronic

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.

Biological: Autologous Stem Cell Transplantation
Autologous neural stem cell transplantation Stem Cell Transplantation by intraspinal and intrathecal injection with 3D matrix as needed
Experimental: Tetraplegics Chronic
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
Biological: Autologous Stem Cell Transplantation
Autologous neural stem cell transplantation Stem Cell Transplantation by intraspinal and intrathecal injection with 3D matrix as needed

Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02326662


Locations
Russian Federation
Federal Research Clinical Center FMBA of Russia
Moscow, Russian Federation, 115682
Sponsors and Collaborators
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
Novagenesis Foundation
Ophiuchus Technologies AG
Investigators
Principal Investigator: Alexander Averyanov, MD Federal Research Clinical Center FMBA of Russia
  More Information

Responsible Party: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
ClinicalTrials.gov Identifier: NCT02326662     History of Changes
Other Study ID Numbers: FMBA OPH1
First Submitted: November 30, 2014
First Posted: December 29, 2014
Last Update Posted: October 27, 2015
Last Verified: October 2015

Keywords provided by Federal Research Clinical Center of Federal Medical & Biological Agency, Russia:
spinal cord injury
neural stem cells
paraplegia
transplantation

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System