Safety Study of Local Administration of Autologous Bone Marrow Stromal Cells in Chronic Paraplegia (CME-LEM1)
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|ClinicalTrials.gov Identifier: NCT01909154|
Recruitment Status : Completed
First Posted : July 26, 2013
Results First Posted : March 29, 2019
Last Update Posted : March 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Biological: Mesenchymal stromal cell therapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Pilot Study to Evaluate the Security of Local Administration of Autologous Stem Cells Obtained From the Bone Marrow Stroma, in Traumatic Injuries of the Spinal Cord|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||March 2015|
Experimental: Mesenchymal stromal cell therapy
Autologous bone marrow adult mesenchymal stem cells expanded in vitro. Administered by Intrathecal injection (subarachnoid and intramedullary). Depending on centromedullary post-traumatic injury: bone marrow stromal stem cells administration (MSCs) at the minimum dose of 100x106 followed by subarachnoid administration of 30x106 MSCs,3 months later
Biological: Mesenchymal stromal cell therapy
Stem cells administration locally
Other Name: BMMSCs= Bone Marrow Mesenchymal Stem Cells
- Safety-Number of Adverse Events [ Time Frame: Up to 12 months ]
Clinical evaluation of possible adverse effects is performed daily at the first week after the first administration of stem cells and weekly until the 6 months follow-up visit and then at month 9 and 12. .
- During the first stem cells administration (during surgery): Changes in vital signs (ECG, Blood Pressure (BP), Heart Rate (HR) were evaluated
- During the second stem cells administration: Changes in vital signs (BP, HR), headache and meningeal irritation were evaluated
- During the first weeks, after the first and the second administrations, the possibility of meningeal irritation, headache and infectious complications were considerate.
MedDRA stardards are followed
- Efficacy-Sensitivity Recovery Using ASIA Scale [ Time Frame: sensitivity before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period) ]
Sensitivity recovery was measured using the ASIA (American Spinal Injury Association) scale to measure the Surface sensitivity (LTS), pain sensitivity (PPS), and the degree of motor function in key muscles (MS). The sum of MS, LTS, and PPS configure total ASIA score. A minimum possible score is 0 points. A maximum possible score is 224 points for a patient with normal sensation.
ASIA score was obtained before surgery, and 3, 6, 9 and 12 months after surgery. Mean and standard deviation for the 12 patients were obtained at all the time points and statistically analyzed.
- Efficacy-Changes in the Level of Chronic Pain Based on the IANR-SCIFRS Scale (Pain Section) [ Time Frame: Changes in the level of Chronic pain before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period) ]
Changes in the level of chronic pain, measured by the pain section of the IANR-SCIFRS (Spinal cord injury functional rating scale (SCI-FRS) of the international association of neuroestoratology (IANR). The minimum posible score is 0, and the máximum posible score is 48, being a score of 48 a normal functioning across all categories, and 0 a severe degree of functional hándicap (significant impact of daily life).
Pain is classified as no pain; mild pain, ordinary pain killer, effective;severe pain, narcotics required; extreme pain, uncontrolled.
- Efficacy- Changes in the Neurophysiological Parameters Measured as the Number of Patients With SSEPs (Somatosensory Evoked Potentials) [ Time Frame: Changes in the level neurophysiological parameters improvement (baseline visit) and 6, 12 months after surgery (follow-up period) ]Changes in the neurophysiological parameters (SSEPs, somatosensory evoked potentials) measured as number of patients WITH SSEPs, each patient through underwent neurophysiological studies before treatment, as well as six and 12 months after surgery, paying attention mainly to the presence or abscence of somatosensory evoked potentials (SSEPs), the presence or absence of motor evoked potentials (MEPs) elicited by magnetic stimulation over the scalp, and to electromyographic (EMG) recording of motor unit potentials in infralesional muscles. Previous to cell therapy in any of the patients SSEPs were recorded.
- Efficacy-Urodynamic Studies in Terms of máximum Cystometric Capacity [ Time Frame: Urodynamic studies before surgery and 12 months after surgery (follow-up period) ]Urodynamic studies in terms of voluntary micturition in flowmetry or in pressure/flow test, increase in bladder compliance. detrusor pressure (decrease on detrusor pressure is considered a clinical improvement). The neurogenic bladder is one of the biggest problems associated with SCI (spinal cord injury), with important personal and social implications.
- Efficacy-modification of Magnetic Resonance Imaging (MRI) [ Time Frame: changes in the spinal cord morphology on neuroimaging studies before surgery and 12 months after surgery (follow-up period) ]Number of patients with a decrease in volume and hyperintensity of intramedullary lesions. In general, in the areas of SCI, variable degree of spinal cord atrophy and hiperintense images are observed. These images corresponds to cysts, gliosis and myelomalacia. After cell administration a reduction of supposed cyst and a decrease or disappearance of hyperintense lesions suggest a patient improvement.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01909154
|Hospital Puerta de Hierro|
|Majadahonda, Madrid, Spain, 28222|
|Principal Investigator:||Jesus JV Vaquero Crespo, Dr.||Hospital Universitario Puerta de Hierro-Majadahonda|