Spinal Cord Injury
Conditions
Keywords
Analyze clinical efficacy of subarachnoid administration of, autologous BMSC expanded in vitro
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALAdult 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.
Sponsors
Puerta de Hierro University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Incomplete SCI 2. Neurological deficit clinically stable at least 12 months prior to treatment, and with a minimum of one-year evolution after SCI. 3. Neurophysiological confirmation of incomplete SCI. 4. The MRI study that morphologically evaluate the SCI. 5. Age between 18 and 70 years 6. Thread Men and women will compromise to use anticonceptive issues from first cell´s extraction to 6 months after last cell´s administration. 7. Ability to attend clinical follow-up and perform physical therapy through the treatment period. 8. Written and signed informed consent, according to the local regulation. 9. Hematologic and creatinin parameters, SGOT and SGPT, within the normal range, according to laboratory standards considering that small variations could be accepted based on clinical study team criteria.
Exclusion criteria
1. A classification in ASIA and FRANKEL clinical scales to evaluate the SCI. 2. Neurophysiological records that confirm the complete SCI. 3. Age below 18 years or above 70. 4. Pregnancy or lactation. 5. Malignancy disease diagnosed or treated within the last 5 years. 6. Patients with systemic disease that represents and additional risk to treatment. 7. Patients with uncertain commitment to follow the physical therapy and clinical visits as well as patient with a negative input in the previous phycological assessment. 8. Inability to assess the SCI features through MRI either noise due to spinal stabilization systems or any other cause. 9. Patients currently under hematopoietic growth factors treatment or who required or maintained anticoagulation. 10. Neurodegenerative disease additional. 11. History of substance abuse, psychiatric disease or allergy to the protein products used in the process of cell expansion. 12. Positive serology for HIV and syphilis. 13. Active Hepatitis B or Hepatitis C. 14. With other reason that would consider the patient ineligible for cell therapy according to the investigators judgment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy-modification of Magnetic Resonance Imaging (MRI) | before (baseline visit) and at 12 months | Number of patients with changes in morphology of injury compared with basal images |
| Efficacy-Urodynammic in Terms of Detrusor Pressure | Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up | Urodynamic studies in terms of detrusor pressure (decrease on detrusor pressure is considered a clinical improvement) |
| Efficacy-Urodynamic Studies Bladder Compliance | measure before treatment (baseline visit), 6 and 12 months after surgery | 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. |
| Efficacy-Sensivity Improvement Using the ASIA Score | measure before treatment (baseline visit), 3, 6, 9 and 12 months after surgery | 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. |
| Efficacy- Changes in Functional Independence Measure Scale | measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery | \- 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. |
| Efficacy-Change in Barthel Score | measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery | \- 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. |
| Efficacy-IANC-SCIFRS Scale | Changes in IANC-SCIFRS scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period) | -Changes in IANC-SCIFRS scale Ranges score: 0 to 48. Being 0 severe degree of disability and 48 normal value. |
| Efficacy-Changes in PENN Score. | measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery | \- 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. |
| Changes in ASHWORTH Score | measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery | \- 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 |
| Efficacy-Changes in EVA Score | measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery | • 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. |
| Efficacy- Changes in Geffner Score | Changes in Geffner scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period) | 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 |
| Efficacy- Changes in NBD Score | measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery | 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. |
| Efficacy-Urodynamic Studies Maximum Cystometric Capacity | Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up | Urodynamic studies in terms of Maximum cystometric capacity |
| Efficacy-Changes in the Neurophysiological Parameters (SSEPs, Somatosensory Evoked Potentials) | Efficacy-measure before treatment (baseline visit), 6, and 12 months after surgery | Changes in the neurophysiological parameters (SSEPs, somatosensory evoked potentials) measured as the number of patients that improved along the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy- Expression of Neurotrophins in CSF (CerebroSpinal Fluid) Samples | Basal and 10 months after the administration | 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. |
| Number of Adverse Events . | Up to 12 months | \- 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). |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Autologous Mesenchymal Bone Marrow Cell |
|---|---|
| Age, Continuous | 42.2 years STANDARD_DEVIATION 9.3 |
| Region of Enrollment Spain | 10 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 9 / 10 |
| serious Total, serious adverse events | 1 / 10 |
Outcome results
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
Time frame: measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Autologous Mesenchymal Bone Marrow Cell | Changes in ASHWORTH Score | before surgery | 1.4 score on a scale | Standard Deviation 0.81 |
| Autologous Mesenchymal Bone Marrow Cell | Changes in ASHWORTH Score | 3 months | 1.4 score on a scale | Standard Deviation 0.81 |
| Autologous Mesenchymal Bone Marrow Cell | Changes in ASHWORTH Score | 6 months | 1.4 score on a scale | Standard Deviation 0.81 |
| Autologous Mesenchymal Bone Marrow Cell | Changes in ASHWORTH Score | 9 months | 1.4 score on a scale | Standard Deviation 0.81 |
| Autologous Mesenchymal Bone Marrow Cell | Changes in ASHWORTH Score | 12 months | 1.10 score on a scale | Standard Deviation 0.99 |
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.
Time frame: measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-Change in Barthel Score | before surgery | 58 score on a scale | Standard Deviation 36.07 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-Change in Barthel Score | 3 months | 58 score on a scale | Standard Deviation 36.07 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-Change in Barthel Score | 6 months | 58 score on a scale | Standard Deviation 36.07 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-Change in Barthel Score | 9 months | 58 score on a scale | Standard Deviation 36.07 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-Change in Barthel Score | 12 months | 65 score on a scale | Standard Deviation 35.59 |
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.
Time frame: measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-Changes in EVA Score | before surgery | 1.70 score on a scale | Standard Deviation 3.13 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-Changes in EVA Score | 3 months | 0.70 score on a scale | Standard Deviation 1.16 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-Changes in EVA Score | 6 months | 0.60 score on a scale | Standard Deviation 0.97 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-Changes in EVA Score | 9 months | 0.40 score on a scale | Standard Deviation 0.84 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-Changes in EVA Score | 12 months | 0.40 score on a scale | Standard Deviation 0.84 |
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.
Time frame: measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Autologous Mesenchymal Bone Marrow Cell | Efficacy- Changes in Functional Independence Measure Scale | before surgery | 95.7 score on a scale | Standard Deviation 33.9 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy- Changes in Functional Independence Measure Scale | 3 months | 95.7 score on a scale | Standard Deviation 33.9 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy- Changes in Functional Independence Measure Scale | 6 months | 95.7 score on a scale | Standard Deviation 33.9 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy- Changes in Functional Independence Measure Scale | 9 months | 96.10 score on a scale | Standard Deviation 33.42 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy- Changes in Functional Independence Measure Scale | 12 months | 98.6 score on a scale | Standard Deviation 32.05 |
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
Time frame: Changes in Geffner scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Autologous Mesenchymal Bone Marrow Cell | Efficacy- Changes in Geffner Score | before surgery | 3.30 score on a scale | Standard Deviation 1.34 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy- Changes in Geffner Score | 3 months | 3.60 score on a scale | Standard Deviation 1.26 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy- Changes in Geffner Score | 6 months | 3.80 score on a scale | Standard Deviation 1.14 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy- Changes in Geffner Score | 9 months | 3.90 score on a scale | Standard Deviation 1.1 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy- Changes in Geffner Score | 12 months | 4.20 score on a scale | Standard Deviation 1.23 |
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.
Time frame: measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Autologous Mesenchymal Bone Marrow Cell | Efficacy- Changes in NBD Score | before surgery | 10.60 score on a scale | Standard Deviation 6.64 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy- Changes in NBD Score | 3 months | 6.10 score on a scale | Standard Deviation 4.15 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy- Changes in NBD Score | 6 months | 5.70 score on a scale | Standard Deviation 4.35 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy- Changes in NBD Score | 9 months | 4.40 score on a scale | Standard Deviation 3.86 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy- Changes in NBD Score | 12 months | 4.20 score on a scale | Standard Deviation 3.88 |
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.
Time frame: measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-Changes in PENN Score. | before surgery | 1.20 score on a scale | Standard Deviation 1.14 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-Changes in PENN Score. | 3 months | 1.10 score on a scale | Standard Deviation 1.1 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-Changes in PENN Score. | 6 months | 0.90 score on a scale | Standard Deviation 0.88 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-Changes in PENN Score. | 9 months | 0.90 score on a scale | Standard Deviation 0.88 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-Changes in PENN Score. | 12 months | 0.90 score on a scale | Standard Deviation 0.88 |
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.
Time frame: Efficacy-measure before treatment (baseline visit), 6, and 12 months after surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-Changes in the Neurophysiological Parameters (SSEPs, Somatosensory Evoked Potentials) | 6 months | 7 number of patients improved in SSEPs |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-Changes in the Neurophysiological Parameters (SSEPs, Somatosensory Evoked Potentials) | 12 months | 8 number of patients improved in SSEPs |
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.
Time frame: Changes in IANC-SCIFRS scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-IANC-SCIFRS Scale | before surgery | 29.10 score on a scale | Standard Deviation 9.96 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-IANC-SCIFRS Scale | 3 months | 31.5 score on a scale | Standard Deviation 8.89 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-IANC-SCIFRS Scale | 6 months | 33.90 score on a scale | Standard Deviation 9.73 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-IANC-SCIFRS Scale | 9 months | 35.9 score on a scale | Standard Deviation 9.01 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-IANC-SCIFRS Scale | 12 months | 36.9 score on a scale | Standard Deviation 8.21 |
Primary
Efficacy-modification of Magnetic Resonance Imaging (MRI)
Number of patients with changes in morphology of injury compared with basal images
Time frame: before (baseline visit) and at 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-modification of Magnetic Resonance Imaging (MRI) | baseline | 0 number of patients |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-modification of Magnetic Resonance Imaging (MRI) | 12 months | 0 number of patients |
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.
Time frame: measure before treatment (baseline visit), 3, 6, 9 and 12 months after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-Sensivity Improvement Using the ASIA Score | before surgery | 188.2 units on a scale | Standard Deviation 60 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-Sensivity Improvement Using the ASIA Score | 3 months | 202.2 units on a scale | Standard Deviation 63.7 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-Sensivity Improvement Using the ASIA Score | 6 months | 218.4 units on a scale | Standard Deviation 57.5 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-Sensivity Improvement Using the ASIA Score | 9 months | 228.9 units on a scale | Standard Deviation 51.84 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-Sensivity Improvement Using the ASIA Score | 12 months | 235.5 units on a scale | Standard Deviation 49.35 |
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.
Time frame: measure before treatment (baseline visit), 6 and 12 months after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-Urodynamic Studies Bladder Compliance | before surgery | 3.88 mL/cm H2O | Standard Deviation 3.24 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-Urodynamic Studies Bladder Compliance | 6 months | 6.14 mL/cm H2O | Standard Deviation 3.36 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-Urodynamic Studies Bladder Compliance | 12 months | 8.28 mL/cm H2O | Standard Deviation 6.41 |
Primary
Efficacy-Urodynamic Studies Maximum Cystometric Capacity
Urodynamic studies in terms of Maximum cystometric capacity
Time frame: Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-Urodynamic Studies Maximum Cystometric Capacity | before surgery | 234.9 mL | Standard Deviation 156.26 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-Urodynamic Studies Maximum Cystometric Capacity | 6 months | 292.4 mL | Standard Deviation 110.93 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-Urodynamic Studies Maximum Cystometric Capacity | 12 months | 292.6 mL | Standard Deviation 183.6 |
Primary
Efficacy-Urodynammic in Terms of Detrusor Pressure
Urodynamic studies in terms of detrusor pressure (decrease on detrusor pressure is considered a clinical improvement)
Time frame: Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-Urodynammic in Terms of Detrusor Pressure | before surgery | 68.6 cm/H2O | Standard Deviation 20.08 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-Urodynammic in Terms of Detrusor Pressure | 6 months | 53.8 cm/H2O | Standard Deviation 20.8 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy-Urodynammic in Terms of Detrusor Pressure | 12 months | 51.5 cm/H2O | Standard Deviation 37.22 |
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.
Time frame: Basal and 10 months after the administration
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Autologous Mesenchymal Bone Marrow Cell | Efficacy- Expression of Neurotrophins in CSF (CerebroSpinal Fluid) Samples | BDNF before administration | 19.14 pg/ml | Standard Deviation 4.58 |
| Autologous Mesenchymal Bone Marrow Cell | Efficacy- Expression of Neurotrophins in CSF (CerebroSpinal Fluid) Samples | BDNF in month 10 after administration | 33.82 pg/ml | Standard Deviation 49.65 |
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).
Time frame: Up to 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Autologous Mesenchymal Bone Marrow Cell | Number of Adverse Events . | 20 Adverse events |