The purpose of this research study is to investigate the safety and potential therapeutic effects of autologous, culture-expanded, adipose derived mesenchymal stem cell intrathecal injections in the treatment of spinal cord injury.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Observation while undergoing Occupational and Physical Therapy for 6 months
The mesenchymal stem cells will be collected and expanded from the patients' adipose tissue.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
•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: up to 12 months post injection
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, up to 12 months post injection
change in Neurogenic Bladder Symptom Score (NBSS)
Neurogenic Bladder Symptom Score (NBSS) The NBSS was designed as an objective and validated way to assess bladder symptoms in patients with neurogenic bladder dysfunction as a result of spinal cord injury, multiple sclerosis, and spinal bifida. The NBSS consists of 24 questions. The first question classifies patients by bladder management, but does not make up part of the numeric score. The remaining questions address 3 domains: incontinence, storage and voiding, and consequences. The final question is an overall quality of life question. The total score can range from 0 (no symptoms at all) to 74 (maximum symptoms).
Time frame: up to 24 months post injection
change in Neurogenic Bowel Symptom Score
The Adult Neurogenic Bowel Dysfunction Score¹, also known as the Adult NBD score has been designed to help healthcare professionals evaluate the effectiveness of their patient's current bowel management routine by assessing the impact it has on the patient's quality of life. By having your patients answer 10 simple questions, the Adult NBD Score can help identify and quantify severity of bowel dysfunction in the adult patients. The Adult NBD score consists of 10 questions and is a symptom-score where each symptom is weighted based on its impact on quality of life. The scores from each question are added together and a total score is calculated. The maximum score is 47 while minimum is 0. Score Severity of bowel dysfunction 0-6 Very minor 7-9 Minor 10-13 Moderate 14+ Severe
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Time frame: up to 24 months post injection
Incidence of abnormal CSF composition
Composition in reference to normal laboratory values.
Time frame: up to 4 weeks post injection
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: up to 12 months post injection
Correlation 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: up to 4 weeks post injection