Neural Stem Cell Transplantation in Traumatic Spinal Cord Injury

NCT02326662 | Unknown Phase 1 DMC

• 1 other identifier: FMBA OPH1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spinal Cord Injury

Keywords

spinal cord injury; neural stem cells; paraplegia; transplantation

Outcome Measures

Primary Outcomes (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

  24 months

Secondary Outcomes (2)

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

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

• MRI Scan of Spinal Cord

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

Study Arms (6)

Paraplegics Acute

EXPERIMENTAL

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

Paraplegics Sub-chronic

EXPERIMENTAL

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

Paraplegics Chronic

EXPERIMENTAL

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

Tetraplegics Acute

EXPERIMENTAL

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

Tetraplegics Sub-chronic

EXPERIMENTAL

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

Tetraplegics Chronic

EXPERIMENTAL

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

Interventions

Autologous Stem Cell Transplantation BIOLOGICAL

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

Paraplegics Acute; Paraplegics Chronic; Paraplegics Sub-chronic; Tetraplegics Acute; Tetraplegics Chronic; Tetraplegics Sub-chronic

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Federal Research Clinical Center of Federal Medical & Biological Agency, Russia: lead
• Novagenesis Foundation: collaborator
• Ophiuchus Technologies AG: collaborator

Study Sites (1)

Federal Research Clinical Center FMBA of Russia

Moscow, 115682, Russia

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Paraplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexander Averyanov, MD

  Federal Research Clinical Center FMBA of Russia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2014
• First Posted: December 29, 2014
• Study Start: July 1, 2014
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 27, 2015

Record last verified: 2015-10

Locations

RU (1)