Neural Stem Cell Transplantation in Traumatic Spinal Cord Injury

NCT ID: NCT02326662

Last Updated: 2015-10-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2018-12-31

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.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Autologous Stem Cell Transplantation

Intervention Type: BIOLOGICAL

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

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.

Group Type: EXPERIMENTAL

Autologous Stem Cell Transplantation

Intervention Type: BIOLOGICAL

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

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.

Group Type: EXPERIMENTAL

Autologous Stem Cell Transplantation

Intervention Type: BIOLOGICAL

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

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.

Group Type: EXPERIMENTAL

Autologous Stem Cell Transplantation

Intervention Type: BIOLOGICAL

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

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.

Group Type: EXPERIMENTAL

Autologous Stem Cell Transplantation

Intervention Type: BIOLOGICAL

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

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

Group Type: EXPERIMENTAL

Autologous Stem Cell Transplantation

Intervention Type: BIOLOGICAL

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

Interventions

Autologous Stem Cell Transplantation

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

Intervention Type: BIOLOGICAL

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novagenesis Foundation

UNKNOWN

Sponsor Role: collaborator

Ophiuchus Technologies AG

UNKNOWN

Sponsor Role: collaborator

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

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander Averyanov, MD

Role: PRINCIPAL_INVESTIGATOR

Federal Research Clinical Center FMBA of Russia

Locations

Federal Research Clinical Center FMBA of Russia

Moscow, , Russia

Countries

Russia

Other Identifiers

FMBA OPH1

Identifier Type: -

Identifier Source: org_study_id