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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023285-46 | EudraCT Number |
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The purpose of this study is to confirm the security, and detect the effect of the local administration in damaged nervous tissue, of autologous bone marrow stromal cells.
It is a clinical trial phase I, single center, non-randomized, uncontrolled, open prospective follow-up of a cohort of patients with chronic spinal cord injury (SCI) who were treated with autologous stromal cells of the bone marrow administrated locally (subarachnoid and intramedullar) by intrathecal microinjection and three months later, by lumbar subarachnoid administration. The minimum follow-up duration for each patient is 12 months after the first administration, or until death, if it occurs it before.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenchymal stromal cell therapy | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal stromal cell therapy | Biological | Stem cells administration locally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety-Number of Adverse Events | 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. .
MedDRA stardards are followed | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy-Sensitivity Recovery Using ASIA Scale | 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. |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jesus JV Vaquero Crespo, Dr. | Hospital Universitario Puerta de Hierro Majadahonda | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Puerta de Hierro | Majadahonda | Madrid | 28222 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19364066 | Background | Geffner LF, Santacruz P, Izurieta M, Flor L, Maldonado B, Auad AH, Montenegro X, Gonzalez R, Silva F. Administration of autologous bone marrow stem cells into spinal cord injury patients via multiple routes is safe and improves their quality of life: comprehensive case studies. Cell Transplant. 2008;17(12):1277-93. doi: 10.3727/096368908787648074. |
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nonymized individual data of participants will be shared with Authorities at the end of the Clinical Development Plan by the CTD (Common Technical Document). Results will be published in a scientific publication.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 100x10^6 followed by subarachnoid administration of 30x10^6 MSCs,3 months later Mesenchymal stromal cell therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 100x10^6 followed by subarachnoid administration of 30x10^6 MSCs,3 months later Mesenchymal stromal cell therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety-Number of Adverse Events | 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. .
MedDRA stardards are followed | 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 | Posted | Number | Adverse events | Up to 12 months |
|
Along the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 100x10^6 followed by subarachnoid administration of 30x10^6 MSCs,3 months later Mesenchymal stromal cell therapy |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| High level of cholesterol in blood | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vaquero Crespo | Hospital Universitario Puerta de Hierro Majadahonda, Madrid | 91 191 7760 | jesus.vaquero@salud.madrid.org |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| sensitivity before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period) |
| Efficacy-Changes in the Level of Chronic Pain Based on the IANR-SCIFRS Scale (Pain Section) | 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. | Changes in the level of Chronic pain before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period) |
| Efficacy- Changes in the Neurophysiological Parameters Measured as the Number of Patients With SSEPs (Somatosensory Evoked Potentials) | 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. | Changes in the level neurophysiological parameters improvement (baseline visit) and 6, 12 months after surgery (follow-up period) |
| Efficacy-Urodynamic Studies in Terms of máximum Cystometric Capacity | 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. | Urodynamic studies before surgery and 12 months after surgery (follow-up period) |
| Efficacy-modification of Magnetic Resonance Imaging (MRI) | 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. | changes in the spinal cord morphology on neuroimaging studies before surgery and 12 months after surgery (follow-up period) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | 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 Mesenchymal stromal cell therapy |
|
|
| Secondary | Efficacy-Sensitivity Recovery Using ASIA Scale | 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. | Posted | Mean | Standard Deviation | units on a scale | sensitivity before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period) |
|
|
|
| Secondary | Efficacy-Changes in the Level of Chronic Pain Based on the IANR-SCIFRS Scale (Pain Section) | 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. | Posted | Mean | Standard Deviation | units on a scale | Changes in the level of Chronic pain before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period) |
|
|
|
| Secondary | Efficacy- Changes in the Neurophysiological Parameters Measured as the Number of Patients With SSEPs (Somatosensory Evoked Potentials) | 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. | Posted | Number | number of patients with SSEPs | Changes in the level neurophysiological parameters improvement (baseline visit) and 6, 12 months after surgery (follow-up period) |
|
|
|
| Secondary | Efficacy-Urodynamic Studies in Terms of máximum Cystometric Capacity | 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. | Posted | Mean | Standard Deviation | cm/H2O | Urodynamic studies before surgery and 12 months after surgery (follow-up period) |
|
|
|
| Secondary | Efficacy-modification of Magnetic Resonance Imaging (MRI) | 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. | Posted | Number | Patients | changes in the spinal cord morphology on neuroimaging studies before surgery and 12 months after surgery (follow-up period) |
|
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|
| 0 |
| 12 |
| 12 |
| 12 |
| Pain | General disorders | MedDRA (18.1) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| High level of alkaline phosphatase in blood | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
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| Perineal abscess | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Infectious mononucleosis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Subcutaneous seroma | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
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| Hemorrhoidectomy | Surgical and medical procedures | MedDRA (18.1) | Systematic Assessment |
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| Pressure ulcer | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Iron deficiency anemia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
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| Intercostal nerualgia | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Saline extravasation | General disorders | MedDRA (18.1) | Systematic Assessment |
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| Local edema | General disorders | MedDRA (18.1) | Systematic Assessment |
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| Hyperthermia | General disorders | MedDRA (18.1) | Systematic Assessment |
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| Thoracic pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Muscle contracture | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
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| Urinary disconfort | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
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| D014947 | Wounds and Injuries |
| Title | Measurements |
|---|---|
|
| 9 months after surgery |
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| 12 months after surgery |
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| Title | Measurements |
|---|---|
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| 9 months after surgery |
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| 12 months after surgery |
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| Title | Measurements |
|---|---|
|