Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury

Study Overview
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Brief Summary
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Human Umbilical Cord-derived Mesenchymal Stem Cells (UC-MSC) and Bone Marrow Mononuclear Cells (BMMC) from the patient injected into the spinal fluid intrathecally and injected intravenously (IV) is a safe and therapeutic procedure for spinal cord injury (SCI) patients.

Detailed Description
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The proposed study will assess primary safety and secondary efficacy endpoints of autologous bone marrow mononuclear cells and allogeneic human umbilical cord-derived mesenchymal stem cells administered to 20 male and female subjects between ages of 18-50 with spinal cord injury. These cells will be administered intrathecally and intravenously multiple times over the course of one month. The primary objective is freedom from treatment-associated adverse events at 3 and 12 months post-treatment. Secondary objective will be efficacy at baseline, 3 months and 12 months and will be quantified based on the following: American Spinal Cord Injury Association (ASIA) classification and the Frankel Scale.

Official Title
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Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Biological: Intravenous and intrathecal human umbilical cord tissue-derived mesenchymal stem cells and bone marrow mononuclear cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women between age 18 and 50 Paraplegics and quadriplegics with complete or incomplete spinal cord injuries. Willingness to undergo bone marrow derived autologous cell therapy. Ability and willingness to make regular visits to hospital and follow ups during the protocol procedure and comply with all medical instructions Traumatic Injury of spinal cord with complete or partial damage by Magnetic Resonance Imaging (MRI) and injury level below C4 ASIA impairment scale from A - C Must have proof of health insurance in country of residence. Signed informed consent Exclusion Criteria: Pre- existing or current systemic disease such as lung, liver (exception: history of uncomplicated hepatitis A), gastrointestinal, cardiac, Human Immunodeficiency Virus (HIV) History of life threatening allergic- or immune-mediated reaction Hemodynamic instability Peripheral muscular dystrophy Lactating or pregnant woman Women capable of childbearing unwilling to use multiple forms of contraception Alcohol drug abuse /dependence Positive test result for hepatitis A and Hepatitis B OR C Major-traumatic brain injury and psychiatric illness Open injuries Active infectious diseases Life expectancy of less than one year due to terminal condition Neurodegenerative diseases Primary hematologic diseases Any of the following medications that cannot be discontinued one week prior to the first stem cell administration and throughout the course of treatment. (1 week before visit 2 through one week after visit 12) Antibiotics Antifungals Antivirals Blood thinners (to avoid bleeding risk during bone marrow aspiration and IT procedures) High doses of Vitamin D or fish oils (since these might prolong bleeding times) Bone reflecting increased risk for spinal puncture Hepatic dysfunction Other medical complications that contraindicate surgery, including major respiratory complications Participation in another clinical trial Coagulopathies Uncorrected coagulopathy during the baseline period defined as: International Normalized Ratio (INR) > 1.4; Partial Thromboplastin Time (PTT) > 35 sec; Platelet Count (PLT) < 100,000. Pre-injury history of seizure disorder and/or neurological impairment where participation in age-appropriate pain rating scales would not be practical or possible Subject does not sign informed consent form

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV and IT UC-MSC and BMMC<br>Intravenous and intrathecal human umbilical cord tissue-derived mesenchymal stem cells and bone marrow mononuclear cells | Biological: Intravenous and intrathecal human umbilical cord tissue-derived mesenchymal stem cells and bone marrow mononuclear cells<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events | 12 and 52 weeks after final treatment | 12 weeks, 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with a change in American Spinal Injury Association (ASIA) score from baseline | 12 and 52 weeks after final treatment | 12 weeks, 52 weeks | 
| Number of subjects with a change in Frankel Scale score from baseline | 12 and 52 weeks from final treatment | 12 weeks, 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mesenchymal, spinal cord injury, bone marrow, mononuclear cells, stem cells, umbilical cord