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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005684-24 | Registry Identifier | 2011-005684-24 |
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The study goes on 24 months, with recruiting, treatment and follow period for all patients. The first day for each patient will be the first cellular administration. 3 doses will be administrated every 3 months from first dose.
When the clinical trial finishes, it will be done a completed check of all obtained parameters.
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) .10 patients will be included with this injury.
Primary objective: Analyze the possible clinical efficacy of administration of main adult mesenchymal autologous cells expanded "in vitro" in patients with incomplete and chronically established SCI.
Secondary objectives: Confirm the safety of treatment, and study possible changes in the cerebrospinal fluid (CSF) levels (Brain-derived neurotrophic factor (BDNF), glial cell line-derived neurotrophic factor (GDNF), nerve growth factor (NGF), ciliary neurotrophic factor (CNTF), Nerve Growth Factor 3 and 4(NT3 and NT4) after subarachnoid administration of BMMC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous Mesenchymal Bone Marrow Cell | Experimental | All patients will be treated with the same treatment: Adult Autologous Mesenchymal Bone Marrow Cell |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adult Autologous Mesenchymal Bone Marrow Cell | Biological | Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy-Sensivity Improvement Using the ASIA Score | Sensitivity improvement 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 10 patients were obtained at all the time points and statistically analyzed. | measure before treatment (baseline visit), 3, 6, 9 and 12 months after surgery |
| Efficacy- Changes in Functional Independence Measure Scale | - Changes in Functional Independence Measure scale (NIF scale), score at the beginning, through and the end of the treatment. Ranges score: 18 to 126. Being 18 total patient dependency and 126 total patient independence. | measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery |
| Efficacy-Change in Barthel Score | - Changes in Barthel score at the beginning, through and the end of the treatment. Ranges score: 0 to 100. Being 0 total patient dependency and 100 total patient independence. | measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery |
| Efficacy-IANC-SCIFRS Scale | -Changes in IANC-SCIFRS scale Ranges score: 0 to 48. Being 0 severe degree of disability and 48 normal value. | Changes in IANC-SCIFRS scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period) |
| Efficacy-Changes in PENN Score. | - Changes in PENN score at the beginning, through and the end of the treatment Ranges score: 0 to 4. Being 0 absence of spasms and 4 frequency greater than 10 spasms per hour. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events . | - The safety will be valued with number of adverse events related with administration of subarachnoid autologous Bone Marrow Expanded Mesenchymal Cells in Incomplete Spinal Cord Injury (SCI). | Up to 12 months |
| Efficacy- Expression of Neurotrophins in CSF (CerebroSpinal Fluid) Samples |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jesús JV Vaquero Crespo, M.D. | 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 |
|---|---|---|---|
| 21163325 | Background | Vaquero J, Zurita M. Functional recovery after severe CNS trauma: current perspectives for cell therapy with bone marrow stromal cells. Prog Neurobiol. 2011 Mar;93(3):341-9. doi: 10.1016/j.pneurobio.2010.12.002. Epub 2010 Dec 14. | |
| 21208021 | Background | Otero L, Zurita M, Bonilla C, Aguayo C, Vela A, Rico MA, Vaquero J. Late transplantation of allogeneic bone marrow stromal cells improves neurologic deficits subsequent to intracerebral hemorrhage. Cytotherapy. 2011 May;13(5):562-71. doi: 10.3109/14653249.2010.544720. Epub 2011 Jan 5. |
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Anonymized 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 | Autologous Mesenchymal Bone Marrow Cell | Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10^6 cells for each patient |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Autologous Mesenchymal Bone Marrow Cell | Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10^6 cells for each patient |
| 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 | Efficacy-Sensivity Improvement Using the ASIA Score | Sensitivity improvement 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 10 patients were obtained at all the time points and statistically analyzed. | Posted | Mean | Standard Deviation | units on a scale | measure before treatment (baseline visit), 3, 6, 9 and 12 months after surgery |
|
2 years
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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 | Autologous Mesenchymal Bone Marrow Cell | Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10^6 cells for each patient |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Acute Bronchitis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA (18.1) | Systematic Assessment | Hypertension |
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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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| measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery |
| Changes in ASHWORTH Score | - Changes in ASHWORTH score at the beginning, through and the end of the treatment Ranges score: 0 to 4. Being 0 when there isn´t increase in muscle tone when stretching, and 4 when there is rigid affected follow-up in flexion or extension | measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery |
| Efficacy-Changes in EVA Score | • Changes in EVA score at the beginning, through and the end of the treatment Ranges score: 0 to 10. Being 0 absence of pain and 10 the worst pain. | measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery |
| Efficacy- Changes in Geffner Score | changes in Geffner score before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period) Ranges score: 0 to 6. Being 0 absence of bladder control and 6 total control of bladder | Changes in Geffner scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period) |
| Efficacy- Changes in NBD Score | changes in NBD score before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period) Ranges score: 0 to 47. 0-6 is very minor dysfunction. 7-9 is minor dysfunction. 10-13 is moderate dysfunction; and 14 or more is severe dysfunction. | measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery |
| Efficacy-Changes in the Neurophysiological Parameters (SSEPs, Somatosensory Evoked Potentials) | Changes in the neurophysiological parameters (SSEPs, somatosensory evoked potentials) measured as the number of patients that improved along the study. | Efficacy-measure before treatment (baseline visit), 6, and 12 months after surgery |
| Efficacy-Urodynammic in Terms of Detrusor Pressure | Urodynamic studies in terms of detrusor pressure (decrease on detrusor pressure is considered a clinical improvement) | Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up |
| Efficacy-Urodynamic Studies Bladder Compliance | Urodynamic studies in terms of Bladder compliance. Bladder compliance is the result of a mathematical calculation of volume responsible for 1 cm H2O pressure rise measured during a cystometric filling . It gives an indication on how the different mechanisms in the bladder wall react on stretching. It is obvious that compliance figures can vary widely in groups which makes it difficult to define limits of normality. | measure before treatment (baseline visit), 6 and 12 months after surgery |
| Efficacy-Urodynamic Studies Maximum Cystometric Capacity | Urodynamic studies in terms of Maximum cystometric capacity | Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up |
| Efficacy-modification of Magnetic Resonance Imaging (MRI) | Number of patients with changes in morphology of injury compared with basal images | before (baseline visit) and at 12 months |
Changes in expression of neurotrophins in CSF (CerebroSpinal Fluid) samples obtained previously to first administration of cell therapy, and previously to the last administration, at month 10, in order to study the variability in the expression of neurotrophins along time. The mean+SD (standard deviation) at each time point was obtained. The tested neurotrophins were: BDNF. |
| Basal and 10 months after the administration |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Efficacy- Changes in Functional Independence Measure Scale | - Changes in Functional Independence Measure scale (NIF scale), score at the beginning, through and the end of the treatment. Ranges score: 18 to 126. Being 18 total patient dependency and 126 total patient independence. | Posted | Mean | Standard Deviation | score on a scale | measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery |
|
|
|
| Primary | Efficacy-Change in Barthel Score | - Changes in Barthel score at the beginning, through and the end of the treatment. Ranges score: 0 to 100. Being 0 total patient dependency and 100 total patient independence. | Posted | Mean | Standard Deviation | score on a scale | measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery |
|
|
|
| Primary | Efficacy-IANC-SCIFRS Scale | -Changes in IANC-SCIFRS scale Ranges score: 0 to 48. Being 0 severe degree of disability and 48 normal value. | Posted | Mean | Standard Deviation | score on a scale | Changes in IANC-SCIFRS scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period) |
|
|
|
| Primary | Efficacy-Changes in PENN Score. | - Changes in PENN score at the beginning, through and the end of the treatment Ranges score: 0 to 4. Being 0 absence of spasms and 4 frequency greater than 10 spasms per hour. | Posted | Mean | Standard Deviation | score on a scale | measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery |
|
|
|
| Primary | Changes in ASHWORTH Score | - Changes in ASHWORTH score at the beginning, through and the end of the treatment Ranges score: 0 to 4. Being 0 when there isn´t increase in muscle tone when stretching, and 4 when there is rigid affected follow-up in flexion or extension | Posted | Mean | Standard Deviation | score on a scale | measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery |
|
|
|
| Primary | Efficacy-Changes in EVA Score | • Changes in EVA score at the beginning, through and the end of the treatment Ranges score: 0 to 10. Being 0 absence of pain and 10 the worst pain. | Posted | Mean | Standard Deviation | score on a scale | measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery |
|
|
|
| Primary | Efficacy- Changes in Geffner Score | changes in Geffner score before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period) Ranges score: 0 to 6. Being 0 absence of bladder control and 6 total control of bladder | Posted | Mean | Standard Deviation | score on a scale | Changes in Geffner scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period) |
|
|
|
| Primary | Efficacy- Changes in NBD Score | changes in NBD score before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period) Ranges score: 0 to 47. 0-6 is very minor dysfunction. 7-9 is minor dysfunction. 10-13 is moderate dysfunction; and 14 or more is severe dysfunction. | Posted | Mean | Standard Deviation | score on a scale | measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery |
|
|
|
| Primary | Efficacy-Changes in the Neurophysiological Parameters (SSEPs, Somatosensory Evoked Potentials) | Changes in the neurophysiological parameters (SSEPs, somatosensory evoked potentials) measured as the number of patients that improved along the study. | Posted | Number | number of patients improved in SSEPs | Efficacy-measure before treatment (baseline visit), 6, and 12 months after surgery |
|
|
|
| Primary | Efficacy-Urodynammic in Terms of Detrusor Pressure | Urodynamic studies in terms of detrusor pressure (decrease on detrusor pressure is considered a clinical improvement) | Posted | Mean | Standard Deviation | cm/H2O | Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up |
|
|
|
| Primary | Efficacy-Urodynamic Studies Bladder Compliance | Urodynamic studies in terms of Bladder compliance. Bladder compliance is the result of a mathematical calculation of volume responsible for 1 cm H2O pressure rise measured during a cystometric filling . It gives an indication on how the different mechanisms in the bladder wall react on stretching. It is obvious that compliance figures can vary widely in groups which makes it difficult to define limits of normality. | Posted | Mean | Standard Deviation | mL/cm H2O | measure before treatment (baseline visit), 6 and 12 months after surgery |
|
|
|
| Primary | Efficacy-Urodynamic Studies Maximum Cystometric Capacity | Urodynamic studies in terms of Maximum cystometric capacity | Posted | Mean | Standard Deviation | mL | Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up |
|
|
|
| Primary | Efficacy-modification of Magnetic Resonance Imaging (MRI) | Number of patients with changes in morphology of injury compared with basal images | Posted | Number | number of patients | before (baseline visit) and at 12 months |
|
|
|
| Secondary | Number of Adverse Events . | - The safety will be valued with number of adverse events related with administration of subarachnoid autologous Bone Marrow Expanded Mesenchymal Cells in Incomplete Spinal Cord Injury (SCI). | Posted | Number | Adverse events | Up to 12 months |
|
|
|
| Secondary | Efficacy- Expression of Neurotrophins in CSF (CerebroSpinal Fluid) Samples | Changes in expression of neurotrophins in CSF (CerebroSpinal Fluid) samples obtained previously to first administration of cell therapy, and previously to the last administration, at month 10, in order to study the variability in the expression of neurotrophins along time. The mean+SD (standard deviation) at each time point was obtained. The tested neurotrophins were: BDNF. | Posted | Mean | Standard Deviation | pg/ml | Basal and 10 months after the administration |
|
|
|
| 0 |
| 10 |
| 1 |
| 10 |
| 9 |
| 10 |
|
| Local pain | General disorders | MedDRA (18.1) | Systematic Assessment | Local pain |
|
| Leg pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment | Leg pain |
|
| Urinary tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment | Urinary tract infection |
|
| Headache | Nervous system disorders | MedDRA (18.1) | Systematic Assessment | Headache |
|
| Hyperthermia | General disorders | MedDRA (18.1) | Systematic Assessment | Hyperthermia |
|
| Wound | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment | Wound |
|
| Infected pressure ulcer | Infections and infestations | MedDRA (18.1) | Systematic Assessment | Infected pressure ulcer |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment | Arthralgia |
|
| Syncope | Nervous system disorders | MedDRA (18.1) | Systematic Assessment | Syncope |
|
| Pain in coccyx | Nervous system disorders | MedDRA (18.1) | Systematic Assessment | Pain in coccyx |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment | Neck pain |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment | Back pain |
|
| Nasopharingytis | Infections and infestations | MedDRA (18.1) | Systematic Assessment | Nasopharingytis |
|
| Bronchitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment | Bronchitis |
|
| Urinary retention | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment | Urinary retention |
|
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| D014947 | Wounds and Injuries |
| Title | Measurements |
|---|---|
|
| 9 months |
|
| 12 months |
|
| Title | Measurements |
|---|---|
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| 9 months |
|
| 12 months |
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| Title | Measurements |
|---|---|
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| 9 months |
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| 12 months |
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| Title | Measurements |
|---|---|
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| 9 months |
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| 12 months |
|
| Title | Measurements |
|---|---|
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| 9 months |
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| 12 months |
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| Title | Measurements |
|---|---|
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| 9 months |
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| 12 months |
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| Title | Measurements |
|---|---|
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| 9 months |
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| 12 months |
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| Title | Measurements |
|---|---|
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| 9 months |
|
| 12 months |
|
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
|