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Spinal Cord InjuryPhase 1/2NCT02326662

Neural Stem Cell Transplantation in Traumatic Spinal Cord Injury

A Phase 1/2 study testing Autologous Stem Cell Transplantation in people with Spinal Cord Injury, run by Federal Research Clinical Center of Federal Medical & Biological Agency, Russia at 1 site in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This research investigates the use of autologous neural stem cells in patients with complete traumatic spinal cord injury. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Spinal Cord Injury
What is being tested?
Autologous Stem Cell Transplantation
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteRussia
Study dates
Jul 2014to Dec 2018
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)]
Show all 31Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • Federal Research Clinical Center FMBA of Russia

    Moscow, 115682

Other trials in Russia

About this study

Official title: 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.

Read the 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.

Being tested
Autologous Stem Cell Transplantation
Keywords
spinal cord injury, neural stem cells, paraplegia, transplantation
Medical subject headings
Spinal Cord Injuries, Paraplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous Stem Cell TransplantationBiological

    Autologous neural stem cell transplantation Stem Cell Transplantation by intraspinal and intrathecal injection with 3D matrix as needed

Study groups in NCT02326662
Study groupRoleWhat they receive
Paraplegics AcuteExperimentalAcute [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.
Receives: Biological: Autologous Stem Cell Transplantation
Paraplegics Sub-chronicExperimentalSub-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.
Receives: Biological: Autologous Stem Cell Transplantation
Paraplegics ChronicExperimentalChronic [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.
Receives: Biological: Autologous Stem Cell Transplantation
Tetraplegics AcuteExperimentalAcute [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.
Receives: Biological: Autologous Stem Cell Transplantation
Tetraplegics Sub-chronicExperimentalsub-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.
Receives: Biological: Autologous Stem Cell Transplantation
Tetraplegics ChronicExperimentalChronic [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
Receives: Biological: Autologous Stem Cell Transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Side effects is recorded by the hospital staff, in the CRF and by the patient. Surgery procedure is documented by video and standard recording

    Measured: 24 months

Secondary outcomes (2)

  1. 324-point ASIA and other scoring incl. muscle control and voluntary movement and improvement of sphincters control

    Change from Baseline in ASIA Score. All patients are stable ASIA A.

    Measured: 3, 6,12, 24 months and 3 year follow-up

  2. MRI Scan of Spinal Cord

    Change from Baseline of Injury Area. All patients has spinal cord injuries visible on MRI

    Measured: 3, 6,12, 24 months and 3 year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionOct 2018 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02326662
Sponsor's protocol ID
FMBA OPH1
Status last verified
Oct 2015
First submitted
30 Nov 2014
Last updated
27 Oct 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Autologous Stem Cell Transplantation in people with Spinal Cord Injury, run by Federal Research Clinical Center of Federal Medical & Biological Agency, Russia at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02326662.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2015.

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