Neural Stem Cell Transplantation in Traumatic Spinal Cord Injury

October 26, 2015 updated by: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

Safety and Efficacy of Autologous Neural Stem Cell Transplantation in Patients With Traumatic Spinal Cord Injury

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 115682
        • Federal Research Clinical Center FMBA of Russia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Change from Baseline of Injury Area. All patients has spinal cord injuries visible on MRI
3, 6,12, 24 months and 3 year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

Collaborators

Novagenesis Foundation
Ophiuchus Technologies AG

Investigators

  • Principal Investigator: Alexander Averyanov, MD, Federal Research Clinical Center FMBA of Russia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (ANTICIPATED)

October 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

November 30, 2014

First Submitted That Met QC Criteria

December 22, 2014

First Posted (ESTIMATE)

December 29, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

October 27, 2015

Last Update Submitted That Met QC Criteria

October 26, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMBA OPH1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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