Trial Outcomes & Findings for Subarachnoid Administrations of Adults Autologous Mesenchymal Stromal Cells in SCI (NCT NCT02165904)
NCT ID: NCT02165904
Last Updated: 2019-07-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
10 participants
Primary outcome timeframe
measure before treatment (baseline visit), 3, 6, 9 and 12 months after surgery
Results posted on
2019-07-19
Participant Flow
Participant milestones
| Measure |
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
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|---|---|
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Overall Study
STARTED
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10
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Subarachnoid Administrations of Adults Autologous Mesenchymal Stromal Cells in SCI
Baseline characteristics by cohort
| Measure |
Autologous Mesenchymal Bone Marrow Cell
n=10 Participants
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
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Age, Continuous
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42.2 years
STANDARD_DEVIATION 9.30 • n=5 Participants
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Sex: Female, Male
Female
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8 Participants
n=5 Participants
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Sex: Female, Male
Male
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2 Participants
n=5 Participants
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Region of Enrollment
Spain
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10 participants
n=5 Participants
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PRIMARY outcome
Timeframe: measure before treatment (baseline visit), 3, 6, 9 and 12 months after surgerySensitivity 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.
Outcome measures
| Measure |
Autologous Mesenchymal Bone Marrow Cell
n=10 Participants
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
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Efficacy-Sensivity Improvement Using the ASIA Score
before surgery
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188.2 units on a scale
Standard Deviation 60
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Efficacy-Sensivity Improvement Using the ASIA Score
3 months
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202.2 units on a scale
Standard Deviation 63.7
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Efficacy-Sensivity Improvement Using the ASIA Score
6 months
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218.4 units on a scale
Standard Deviation 57.5
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Efficacy-Sensivity Improvement Using the ASIA Score
9 months
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228.9 units on a scale
Standard Deviation 51.84
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Efficacy-Sensivity Improvement Using the ASIA Score
12 months
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235.5 units on a scale
Standard Deviation 49.35
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Autologous Mesenchymal Bone Marrow Cell
n=10 Participants
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
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Efficacy- Changes in Functional Independence Measure Scale
before surgery
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95.7 score on a scale
Standard Deviation 33.9
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Efficacy- Changes in Functional Independence Measure Scale
3 months
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95.7 score on a scale
Standard Deviation 33.9
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Efficacy- Changes in Functional Independence Measure Scale
6 months
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95.7 score on a scale
Standard Deviation 33.9
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Efficacy- Changes in Functional Independence Measure Scale
9 months
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96.10 score on a scale
Standard Deviation 33.42
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Efficacy- Changes in Functional Independence Measure Scale
12 months
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98.6 score on a scale
Standard Deviation 32.05
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Autologous Mesenchymal Bone Marrow Cell
n=10 Participants
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
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Efficacy-Change in Barthel Score
before surgery
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58 score on a scale
Standard Deviation 36.07
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Efficacy-Change in Barthel Score
3 months
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58 score on a scale
Standard Deviation 36.07
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Efficacy-Change in Barthel Score
6 months
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58 score on a scale
Standard Deviation 36.07
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Efficacy-Change in Barthel Score
9 months
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58 score on a scale
Standard Deviation 36.07
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Efficacy-Change in Barthel Score
12 months
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65 score on a scale
Standard Deviation 35.59
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Autologous Mesenchymal Bone Marrow Cell
n=10 Participants
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
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|---|---|
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Efficacy-IANC-SCIFRS Scale
before surgery
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29.10 score on a scale
Standard Deviation 9.96
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Efficacy-IANC-SCIFRS Scale
3 months
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31.5 score on a scale
Standard Deviation 8.89
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Efficacy-IANC-SCIFRS Scale
6 months
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33.90 score on a scale
Standard Deviation 9.73
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Efficacy-IANC-SCIFRS Scale
9 months
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35.9 score on a scale
Standard Deviation 9.01
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Efficacy-IANC-SCIFRS Scale
12 months
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36.9 score on a scale
Standard Deviation 8.21
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Autologous Mesenchymal Bone Marrow Cell
n=10 Participants
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
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|---|---|
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Efficacy-Changes in PENN Score.
before surgery
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1.20 score on a scale
Standard Deviation 1.14
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Efficacy-Changes in PENN Score.
3 months
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1.10 score on a scale
Standard Deviation 1.10
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Efficacy-Changes in PENN Score.
6 months
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0.90 score on a scale
Standard Deviation 0.88
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Efficacy-Changes in PENN Score.
9 months
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0.90 score on a scale
Standard Deviation 0.88
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Efficacy-Changes in PENN Score.
12 months
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0.90 score on a scale
Standard Deviation 0.88
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PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Autologous Mesenchymal Bone Marrow Cell
n=10 Participants
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
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|---|---|
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Changes in ASHWORTH Score
before surgery
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1.4 score on a scale
Standard Deviation 0.81
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Changes in ASHWORTH Score
3 months
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1.4 score on a scale
Standard Deviation 0.81
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Changes in ASHWORTH Score
6 months
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1.4 score on a scale
Standard Deviation 0.81
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Changes in ASHWORTH Score
9 months
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1.4 score on a scale
Standard Deviation 0.81
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Changes in ASHWORTH Score
12 months
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1.10 score on a scale
Standard Deviation 0.99
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Autologous Mesenchymal Bone Marrow Cell
n=10 Participants
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
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|---|---|
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Efficacy-Changes in EVA Score
before surgery
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1.70 score on a scale
Standard Deviation 3.13
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Efficacy-Changes in EVA Score
3 months
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0.70 score on a scale
Standard Deviation 1.16
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Efficacy-Changes in EVA Score
6 months
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0.60 score on a scale
Standard Deviation 0.97
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Efficacy-Changes in EVA Score
9 months
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0.40 score on a scale
Standard Deviation 0.84
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Efficacy-Changes in EVA Score
12 months
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0.40 score on a scale
Standard Deviation 0.84
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PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Autologous Mesenchymal Bone Marrow Cell
n=10 Participants
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
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Efficacy- Changes in Geffner Score
3 months
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3.60 score on a scale
Standard Deviation 1.26
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Efficacy- Changes in Geffner Score
before surgery
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3.30 score on a scale
Standard Deviation 1.34
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Efficacy- Changes in Geffner Score
6 months
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3.80 score on a scale
Standard Deviation 1.14
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Efficacy- Changes in Geffner Score
9 months
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3.90 score on a scale
Standard Deviation 1.10
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Efficacy- Changes in Geffner Score
12 months
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4.20 score on a scale
Standard Deviation 1.23
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PRIMARY outcome
Timeframe: measure before treatment (baseline visit), 3, 6,9 and 12 months after surgerychanges 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.
Outcome measures
| Measure |
Autologous Mesenchymal Bone Marrow Cell
n=10 Participants
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
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|---|---|
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Efficacy- Changes in NBD Score
before surgery
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10.60 score on a scale
Standard Deviation 6.64
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Efficacy- Changes in NBD Score
3 months
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6.10 score on a scale
Standard Deviation 4.15
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Efficacy- Changes in NBD Score
6 months
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5.70 score on a scale
Standard Deviation 4.35
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Efficacy- Changes in NBD Score
9 months
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4.40 score on a scale
Standard Deviation 3.86
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Efficacy- Changes in NBD Score
12 months
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4.20 score on a scale
Standard Deviation 3.88
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PRIMARY outcome
Timeframe: Efficacy-measure before treatment (baseline visit), 6, and 12 months after surgeryChanges in the neurophysiological parameters (SSEPs, somatosensory evoked potentials) measured as the number of patients that improved along the study.
Outcome measures
| Measure |
Autologous Mesenchymal Bone Marrow Cell
n=10 Participants
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
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|---|---|
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Efficacy-Changes in the Neurophysiological Parameters (SSEPs, Somatosensory Evoked Potentials)
6 months
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7 number of patients improved in SSEPs
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Efficacy-Changes in the Neurophysiological Parameters (SSEPs, Somatosensory Evoked Potentials)
12 months
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8 number of patients improved in SSEPs
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PRIMARY outcome
Timeframe: Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-upUrodynamic studies in terms of detrusor pressure (decrease on detrusor pressure is considered a clinical improvement)
Outcome measures
| Measure |
Autologous Mesenchymal Bone Marrow Cell
n=10 Participants
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
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|---|---|
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Efficacy-Urodynammic in Terms of Detrusor Pressure
before surgery
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68.6 cm/H2O
Standard Deviation 20.08
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Efficacy-Urodynammic in Terms of Detrusor Pressure
6 months
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53.8 cm/H2O
Standard Deviation 20.8
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Efficacy-Urodynammic in Terms of Detrusor Pressure
12 months
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51.5 cm/H2O
Standard Deviation 37.22
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PRIMARY outcome
Timeframe: measure before treatment (baseline visit), 6 and 12 months after surgeryUrodynamic 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.
Outcome measures
| Measure |
Autologous Mesenchymal Bone Marrow Cell
n=10 Participants
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
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|---|---|
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Efficacy-Urodynamic Studies Bladder Compliance
before surgery
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3.88 mL/cm H2O
Standard Deviation 3.24
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Efficacy-Urodynamic Studies Bladder Compliance
6 months
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6.14 mL/cm H2O
Standard Deviation 3.36
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Efficacy-Urodynamic Studies Bladder Compliance
12 months
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8.28 mL/cm H2O
Standard Deviation 6.41
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PRIMARY outcome
Timeframe: Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-upUrodynamic studies in terms of Maximum cystometric capacity
Outcome measures
| Measure |
Autologous Mesenchymal Bone Marrow Cell
n=10 Participants
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
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|---|---|
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Efficacy-Urodynamic Studies Maximum Cystometric Capacity
before surgery
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234.9 mL
Standard Deviation 156.26
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Efficacy-Urodynamic Studies Maximum Cystometric Capacity
6 months
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292.4 mL
Standard Deviation 110.93
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Efficacy-Urodynamic Studies Maximum Cystometric Capacity
12 months
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292.6 mL
Standard Deviation 183.6
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PRIMARY outcome
Timeframe: before (baseline visit) and at 12 monthsNumber of patients with changes in morphology of injury compared with basal images
Outcome measures
| Measure |
Autologous Mesenchymal Bone Marrow Cell
n=10 Participants
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
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|---|---|
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Efficacy-modification of Magnetic Resonance Imaging (MRI)
baseline
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0 number of patients
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Efficacy-modification of Magnetic Resonance Imaging (MRI)
12 months
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0 number of patients
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SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Autologous Mesenchymal Bone Marrow Cell
n=10 Participants
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
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|---|---|
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Number of Adverse Events .
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20 Adverse events
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SECONDARY outcome
Timeframe: Basal and 10 months after the administrationChanges 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.
Outcome measures
| Measure |
Autologous Mesenchymal Bone Marrow Cell
n=10 Participants
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
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|---|---|
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Efficacy- Expression of Neurotrophins in CSF (CerebroSpinal Fluid) Samples
BDNF before administration
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19.14 pg/ml
Standard Deviation 4.58
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Efficacy- Expression of Neurotrophins in CSF (CerebroSpinal Fluid) Samples
BDNF in month 10 after administration
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33.82 pg/ml
Standard Deviation 49.65
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Adverse Events
Autologous Mesenchymal Bone Marrow Cell
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Autologous Mesenchymal Bone Marrow Cell
n=10 participants at risk
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
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|---|---|
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Respiratory, thoracic and mediastinal disorders
Bronchitis
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10.0%
1/10 • Number of events 1 • 2 years
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Other adverse events
| Measure |
Autologous Mesenchymal Bone Marrow Cell
n=10 participants at risk
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
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|---|---|
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Vascular disorders
Hypertension
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10.0%
1/10 • Number of events 1 • 2 years
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General disorders
Local pain
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10.0%
1/10 • Number of events 1 • 2 years
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Musculoskeletal and connective tissue disorders
Leg pain
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10.0%
1/10 • Number of events 1 • 2 years
|
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Infections and infestations
Urinary tract infection
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20.0%
2/10 • Number of events 2 • 2 years
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Nervous system disorders
Headache
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30.0%
3/10 • Number of events 4 • 2 years
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General disorders
Hyperthermia
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10.0%
1/10 • Number of events 1 • 2 years
|
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Injury, poisoning and procedural complications
Wound
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10.0%
1/10 • Number of events 1 • 2 years
|
|
Infections and infestations
Infected pressure ulcer
|
10.0%
1/10 • Number of events 1 • 2 years
|
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Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Number of events 1 • 2 years
|
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Nervous system disorders
Syncope
|
10.0%
1/10 • Number of events 1 • 2 years
|
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Nervous system disorders
Pain in coccyx
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10.0%
1/10 • Number of events 1 • 2 years
|
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Musculoskeletal and connective tissue disorders
Neck pain
|
10.0%
1/10 • Number of events 1 • 2 years
|
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Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Infections and infestations
Nasopharingytis
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Infections and infestations
Bronchitis
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Urinary retention
|
10.0%
1/10 • Number of events 1 • 2 years
|
Additional Information
Dr. Vaquero Crespo
Hospital Universitario Puerta de Hierro Majadahonda, Madrid
Phone: 91 191 7760
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place