A Phase 1 interventional study of Autologous, Adipose derived Mesenchymal Stem Cells in Spinal Cord Injuries and Paralysis, sponsored by Mohamad Bydon. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-30.
Sponsored by Mohamad Bydon · Phase 1, Interventional, and Treatment
The purpose of this study is to determine if mesenchymal stem cells (MSC) derived from the fat tissue can be safely administered into the cerebrospinal fluid (CSF) of patients with spinal cord injury. Adipose-derived mesenchymal stem cells (AD-MSCs) have been used in previous research studies at the Mayo Clinic. All subjects enrolled in this study will receive AD-MSC treatment, which is still experimental and is not approved by the U.S. Food and Drug Administration (FDA) for large scale use. However, the FDA has allowed the use of this agent in this research study.
The proposed study is an open label, prospective Phase I safety and feasibility study of the intrathecal injection of autologous culture-expanded AD-MSCs in patients with severe traumatic spinal cord injury (SCI). All subjects will receive the same dosage of stem cells via intrathecal injection. Enrolled subjects will first undergo a minor surgical procedure in which a sample of the patient's adipose tissue will be harvested from a small incision in the patient's abdomen or thigh. The subject's adipose tissue will then be used to derive and culture-expand AD-MSCs for 4-6 weeks. Autologous AD-MSCs will be transplanted through intrathecal injection at the level of L4-5 under fluoroscopic guidance at a single dose of 100 million cells. Patients will be evaluated at set intervals following the injection: day 2, day 3, week 1, week 2, week 4, week 24, weeks 48, week 72 and week 96.
Male or female aged 18 years and older
Exclusion Criteria:
Patients will receive a single dose of 100 million autologous, adipose derived mesenchymal stem cells. The cells are isolated from patient's adipose tissue and expanded for intrathecal delivery.
Biological: Autologous, Adipose derived Mesenchymal Stem Cells
The mesenchymal stem cells will be collected and expanded from the subjects adipose tissue.
Incidence of acute adverse events
An adverse event is defined any untoward or undesirable medical occurrence in the form of signs, symptoms, abnormal findings, or diseases that emerge or worsen relative to baseline (i.e., if present upon study entry) during the study regardless of causal relationship to the study drug
Time frame: up to 4 weeks post treatment
Incidence of delayed adverse events
An adverse event is defined any untoward or undesirable medical occurrence in the form of signs, symptoms, abnormal findings, or diseases that emerge or worsen relative to baseline (i.e., if present upon study entry) during the study regardless of causal relationship to the study drug.
Time frame: 48 weeks post treatment
Severity of adverse events
The severity of adverse events will be graded into the following categories: mild, moderate, and severe.
Time frame: 4 weeks post-treatment
Relationship of adverse events to study drug
The relationship of adverse events to study drug will be graded into the following categories: probable, possible, unlikely, unrelated.
Time frame: 4 weeks post-treatment
Incidence of serious adverse events (SAE)
SAE is defined as adverse events that result in death, life threatening adverse experiences, hospitalization, new or prolonged disability/incapacity.
Time frame: 48 weeks post-treatment
Change in sensory and motor function following completion of treatment as measured by the American Spinal Injury Association (ASIA) Impairment Scale (AIS)
The ASIA Impairment Scale describes a person's functional impairment (both motor and sensory) as a result of their spinal cord injury. The scale has 5 levels, ranging from A (complete) to E (normal).
Time frame: baseline, 96 weeks
Change in sensory and motor function following completion of treatment as measured by motor evoked potentials (MEP)
Motor Evoked Potentials (MEP) are electrical responses recorded either from muscles, or from axons of the descending motor tract, in response to electrical or magnetic stimulation of nervous system structures that govern movement. While there are many different methods for stimulation and recording, the most common approach involves transcranial electrical stimulation of the motor pathway, using subdermal needle electrodes positioned in the scalp above primary motor cortex.
Time frame: baseline, 96 weeks post-treatment
Change in sensory and motor function following completion of treatment as measured by Somatosensory Evoked Potentials (SSEPs)
Somatosensory Evoked Potentials (SSEPs) are electrical responses recorded from the nervous system following electrical stimulation of a peripheral nerve. For example, stimulation of the median nerve at the wrist produces electrical activity that travels along the sensory pathway on its way to the brain. This activity can be recorded with electrodes positioned along that pathway.
Time frame: baseline, 96 weeks post-treatment
Number of subjects who develop a new pathologic mass at the spinal cord area of injection or anywhere along the spinal cord.
Patients will undergo Magnetic Resonance Imaging of the spine and the spinal cord with and without contrast.
Time frame: approximately 96 weeks post-treatment
Change in number of red blood cells following treatment
Blood will be drawn in order to monitor for markers of systemic inflammation. The normal range of red blood cells varies slightly between laboratories but is generally between 4.2 - 5.9 million cells/cmm. This can also be referred to as the erythrocyte count and can be expressed in international units as 4.2 - 5.9 x 10\^12 cells per liter.
Time frame: baseline, 4 weeks post-treatment
Change in white blood cells with differential following treatment
Serological test - Automated white cell differential. A machine generated percentage of the different types of white blood cells, usually split into granulocytes, lymphocytes, monocytes, eosinophils, and basophils.
Time frame: baseline, 4 weeks post-treatment
Change in number of platelets following treatment
Serological test: Platelets are not complete cells, but actually fragments of cytoplasm from a cell found in the bone marrow called a megakaryocyte. Platelets play a vital role in blood clotting. Normal range varies slightly between laboratories but is in the range of 150,000 - 400,000/ cmm (150 - 400 x 10\^9/liter).
Time frame: baseline, 4 weeks post-treatment
Change in Serum C-Reactive Protein (CRP)
Serological test: C-reactive protein (CRP) is produced by the liver. The level of CRP rises when there is inflammation throughout the body. It is one of a group of proteins called acute phase reactants that go up in response to inflammation. C-reactive protein is measured in milligrams of CRP per liter of blood (mg/L). Normal CRP levels are below 3.0 mg/dL.
Time frame: baseline, 4 weeks post-treatment
Change in Erythrocyte Sedimentation Rate (ESR)
Serological test. The erythrocyte sedimentation rate (ESR) is the rate at which red blood cells sediment in a period of one hour. It is a common hematology test, and is a non-specific measure of inflammation. The normal range is 0-22 mm/hr for men and 0-29 mm/hr for women.
Time frame: baseline, 4 weeks post-treatment
Change in Blood Urea Nitrogen (BUN)
Serological test - basic metabolic panel. A blood urea nitrogen (BUN) test measures the amount of nitrogen in the blood that comes from the waste product urea. Urea is made when protein is broken down in the body. Urea is made in the liver and passed out of the body in the urine. A BUN test is done to see how well the kidneys are working. Results of the blood urea nitrogen test are measured in milligrams per deciliter (mg/dL).
Time frame: baseline, 4 weeks post-treatment
Change in Creatinine
Serological test - basic metabolic panel. Creatinine is a waste product produced by muscles from the breakdown of a compound called creatine. Almost all creatinine is filtered from the blood by the kidneys and released into the urine, so blood levels are usually a good indicator of how well the kidneys are working. Results are reported in mg/dL.
Time frame: baseline, 4 weeks post-treatment
Change in Sodium
Serological test - basic metabolic panel. A sodium blood test allows the doctor to see how much sodium is in the subject's blood. It helps maintain normal blood pressure, supports the work of your nerves and muscles, and regulates your body's fluid balance. A normal sodium level is between 135 and 145 milliequivalents per liter (mEq/L) of sodium.
Time frame: baseline, 4 weeks post-treatment
Change in Potassium
Serological test - basic metabolic panel. The normal potassium level in the blood is 3.5-5.0 milliEquivalents per liter (mEq/L).
Time frame: baseline, 4 weeks post-treatment
Change in Chloride
Serological test - basic metabolic panel. The normal blood reference range of chloride for adults in most labs is 96 to 106 milliequivalents (mEq) per liter.
Time frame: baseline, 4 weeks post-treatment
Change in Aspartate Aminotransferase (AST)
Serological test - basic metabolic panel. Inflamed or injured liver cells leak higher than normal amounts of certain chemicals, including liver enzymes, into the bloodstream, which can result in elevated liver enzymes on blood tests. The reference range for aspartate aminotransferase (AST) is as follows: Males: 6-34 IU/L, Females: 8-40 IU/L.
Time frame: baseline, 4 weeks post-treatment
Change in Glucose
Serological test - basic metabolic panel. For a subject without diabetes, a fasting blood sugar on awakening should be under 100 mg/dl.
Time frame: baseline, 4 weeks post-treatment
Change in Carbon Dioxide
Serological test - basic metabolic panel. The normal range for carbon dioxide is 23 to 29 mEq/L (milliequivalent units per liter of blood).
Time frame: baseline, 4 weeks post-treatment
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