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Trial record 11 of 53 for:    stem cell Spinal Cord Injury AND Nervous

Neural Stem Cell Transplantation in Traumatic Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT02326662
Recruitment Status : Unknown
Verified October 2015 by Federal Research Clinical Center of Federal Medical & Biological Agency, Russia.
Recruitment status was:  Active, not recruiting
First Posted : December 29, 2014
Last Update Posted : October 27, 2015
Sponsor:
Collaborators:
Novagenesis Foundation
Ophiuchus Technologies AG
Information provided by (Responsible Party):
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

Tracking Information
First Submitted Date  ICMJE November 30, 2014
First Posted Date  ICMJE December 29, 2014
Last Update Posted Date October 27, 2015
Study Start Date  ICMJE July 2014
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02326662 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2014)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neural Stem Cell Transplantation in Traumatic Spinal Cord Injury
Official Title  ICMJE Safety and Efficacy of Autologous Neural Stem Cell Transplantation in Patients With Traumatic Spinal Cord Injury
Brief Summary This research investigates the use of autologous neural stem cells in patients with complete traumatic spinal cord injury.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injury
Intervention  ICMJE Biological: Autologous Stem Cell Transplantation
Autologous neural stem cell transplantation Stem Cell Transplantation by intraspinal and intrathecal injection with 3D matrix as needed
Study Arms  ICMJE
  • 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.
    Intervention: Biological: Autologous Stem Cell Transplantation
  • 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.
    Intervention: Biological: Autologous Stem Cell Transplantation
  • 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.

    Intervention: Biological: Autologous Stem Cell Transplantation
  • 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.
    Intervention: Biological: Autologous Stem Cell Transplantation
  • 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.

    Intervention: Biological: Autologous Stem Cell Transplantation
  • 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
    Intervention: Biological: Autologous Stem Cell Transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 22, 2014)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02326662
Other Study ID Numbers  ICMJE FMBA OPH1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
Study Sponsor  ICMJE Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
Collaborators  ICMJE
  • Novagenesis Foundation
  • Ophiuchus Technologies AG
Investigators  ICMJE
Principal Investigator: Alexander Averyanov, MD Federal Research Clinical Center FMBA of Russia
PRS Account Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP