Neural Stem Cell Transplantation in Traumatic Spinal Cord Injury

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02326662
• Other study ID #: FMBA OPH1
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: November 30, 2014
• Last updated: October 26, 2015
• Start date: July 2014
• Est. completion date: December 2018

Study information

• Verified date: October 2015
• Source: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Federal Research Clinical Center FMBA of Russia	Moscow

Sponsors (3)

Lead Sponsor	Collaborator
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia	Novagenesis Foundation, Ophiuchus Technologies AG

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	3, 6,12, 24 months and 3 year follow-up	No
Secondary	MRI Scan of Spinal Cord	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	No