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Study of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Ischemic Stroke (ACTIsSIMA)

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ClinicalTrials.gov Identifier: NCT02448641
Recruitment Status : Completed
First Posted : May 19, 2015
Results First Posted : April 17, 2020
Last Update Posted : October 8, 2020
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
SanBio, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Ischemic Stroke
Interventions Biological: SB623 Implant (2.5M)
Biological: SB623 Implant (5.0M)
Procedure: Sham surgery
Enrollment 163
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SB623 Implant (2.5M) SB623 Implant (5.0M) Sham Control
Hide Arm/Group Description

2.5 million SB623 cells

SB623 Implant (2.5M): 2.5 million SB623 cells

5 million SB623 cells

SB623 Implant (5.0M): 5 million SB623 cells

Control Group: Sham surgery
Period Title: Overall Study
Started 55 56 52
Completed 54 51 48
Not Completed 1 5 4
Arm/Group Title SB623 Implant (2.5M) SB623 Implant (5.0M) Sham Control Total
Hide Arm/Group Description 2.5 million SB623 cells 5 million SB623 cells Control Group: Sham surgery Total of all reporting groups
Overall Number of Baseline Participants 55 56 52 163
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants 56 participants 52 participants 163 participants
57.5  (11.08) 58.9  (9.99) 55.2  (11.57) 57.2  (10.92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 56 participants 52 participants 163 participants
Female
21
  38.2%
20
  35.7%
19
  36.5%
60
  36.8%
Male
34
  61.8%
36
  64.3%
33
  63.5%
103
  63.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 56 participants 52 participants 163 participants
Hispanic or Latino
3
   5.5%
3
   5.4%
0
   0.0%
6
   3.7%
Not Hispanic or Latino
52
  94.5%
53
  94.6%
52
 100.0%
157
  96.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 55 participants 56 participants 52 participants 163 participants
Asian 1 2 6 9
Native Hawaiian or Other Pacific Islander 0 0 1 1
Black or African American 6 1 2 9
White 45 51 42 138
Other 3 2 1 6
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 55 participants 56 participants 52 participants 163 participants
55 56 52 163
1.Primary Outcome
Title Proportion of Subjects Whose Fugl-Meyer Motor Total Score (FMMS) Improved by ≥ 10 Points at Month 6 From Baseline
Hide Description

The FMMS is used as a clinical measure of body function impairment after stroke that assesses several dimensions of motor impairment, including range of motion in both upper and lower limbs, reflex activity, volitional movement, and co-ordination.

The FMMS motor component consists of the 33-item upper extremity subscale (UE-FMMS) and the 17-item lower extremity subscale (LE-FMMS). Items were scored on a 3-point ordinal scale:

0= cannot perform; 1= partial motion; 2= full motion

Individual items were then summed to determine scores for the 2 subscale scores, as well as a motor total score (total of all item scores including the 2 subscales UE-FMMS and LE-FMMS). As a result, the UE-FMMS subscale score ranged from 0 to 66 and the LE-FMMS subscale score ranged from 0 to 34. The FMMS motor total score ranged from 0 (hemiplegia) to a maximum of 100 points (normal motor performance).

Responders: subjects whose FMMS motor total score improve by ≥10 points at Month 6 from Baseline

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (mITT) Population: Included all randomized subjects who completed the surgery treatment procedure. A total of 111 subjects received treatment with SB623; 55 subjects were randomized to receive 2.5 million SB623 cells and 56 subjects to receive 5 million SB623 cells.
Arm/Group Title SB623 Implant (2.5M) SB623 Implant (5.0M) Sham Control
Hide Arm/Group Description:

2.5 million SB623 cells

SB623 Implant (2.5M): 2.5 million SB623 cells

5 million SB623 cells

SB623 Implant (5.0M): 5 million SB623 cells

Sham surgery

Sham surgery

Overall Number of Participants Analyzed 55 56 52
Measure Type: Count of Participants
Unit of Measure: Participants
Responder
7
  12.7%
9
  16.1%
7
  13.5%
Non-responder
46
  83.6%
45
  80.4%
38
  73.1%
Unknown
2
   3.6%
2
   3.6%
7
  13.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SB623 Implant (2.5M), SB623 Implant (5.0M), Sham Control
Comments Combined SB623 Implant Vs Sham Surgery group at Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6743
Comments GLMM: Generalized Linear Mixed Model
Method Mixed Models Analysis
Comments A GLMM with FMMS responder as outcome, treatment, visit, treatment-visit interaction, pooled site, Baseline FMMS and Baseline mRS scores as covariates
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.33
Confidence Interval (2-Sided) 95%
0.35 to 5.09
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Modified Rankin Scale Response: The Proportion of Subjects That Improved at Least One Point on the mRS From Baseline
Hide Description

Responders: The subjects that improved at least one point on the mRS from Baseline

Modified Rankin Scale (mRS): This scale is used to measure the degree of disability or dependence in the daily activities of people who had suffered a stroke. The mRS is an ordinal scale from 0 (no symptoms at all) to 5 (severe disability; requiring constant nursing care and attention, bedridden, incontinent) with a sixth category of death.

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (mITT) Population: Included all randomized subjects who completed the surgery treatment procedure. A total of 111 subjects received treatment with SB623; 55 subjects were randomized to receive 2.5 million SB623 cells and 56 subjects to receive 5 million SB623 cells.
Arm/Group Title SB623 Implant (2.5M) SB623 Implant (5.0M) Sham Control
Hide Arm/Group Description:
2.5 million SB623 cells
5 million SB623 cells
Sham surgery Group
Overall Number of Participants Analyzed 55 56 52
Measure Type: Count of Participants
Unit of Measure: Participants
Responder
6
  10.9%
10
  17.9%
9
  17.3%
Non-responder
43
  78.2%
42
  75.0%
35
  67.3%
Unknown
6
  10.9%
4
   7.1%
8
  15.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SB623 Implant (2.5M), SB623 Implant (5.0M), Sham Control
Comments Combined SB623 Implant Vs Sham Surgery group at Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1000
Comments GLMM: Generalized Linear Mixed Model
Method Mixed Models Analysis
Comments A GLMM with mRS responder as outcome, treatment, visit, treatment-visit interaction, pooled site and Baseline mRS scores as covariates
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.43
Confidence Interval (2-Sided) 95%
0.15 to 1.18
Estimation Comments [Not Specified]
3.Secondary Outcome
Title The Proportion of Subjects That Improved at Least 6 Points From Baseline on the ARAT Total Score at the Affected Side
Hide Description

Responders: The subjects that improved at least 6 points from Baseline on the ARAT total score at the affected side.

Action Research Arm Test (ARAT): The test was scored for left and right side separately. Performance on each item was rated on a 4-point ordinal scale ranging from: 3 (performed test normally in less than 5 seconds); 2 (completed test, but took abnormally long or had great difficult, with time varying from 5 to 60 seconds; 1 (performed test partially); 0 (could perform no part of the test). The ARAT is a 19-item measure divided into 4 subtests: Grasp subscale (with 6 items and a score range of 0 to 18); Grip subscale with 4 items and a score range of 0 to 12); Pinch subscale with 6 items and a score range of 0 to 18); Gross arm movement subscale (with 3 items and a score range of 0 to 9). The maximum score on the ARAT is 57 points (possible range 0 to 57) for each side.

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (mITT) Population: Included all randomized subjects who completed the surgery treatment procedure. A total of 111 subjects received treatment with SB623; 55 subjects were randomized to receive 2.5 million SB623 cells and 56 subjects to receive 5 million SB623 cells.
Arm/Group Title SB623 Implant (2.5M) SB623 Implant (5.0M) Sham Control
Hide Arm/Group Description:
2.5 million SB623 cells
5 million SB623 cells
Sham surgery Group (Control)
Overall Number of Participants Analyzed 55 56 52
Measure Type: Count of Participants
Unit of Measure: Participants
Responder
6
  10.9%
9
  16.1%
9
  17.3%
Non-responder
47
  85.5%
45
  80.4%
37
  71.2%
Unknown
2
   3.6%
2
   3.6%
6
  11.5%
4.Secondary Outcome
Title The Proportion of Subjects That Improved at Least 1 Functional Level From Baseline on Gait Velocity
Hide Description

Responders: The subjects that improved at least 1 functional level (eg, from < 0.4 m/s to 0.4-0.8 m/s or from 0.4-0.8 m/s to > 0.8 m/s) from Baseline on Gait Velocity.

Gait Velocity was measured on a standard 10 meter walk. Two trials were tested and the average result from both was used for analysis

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (mITT) Population: Included all randomized subjects who completed the surgery treatment procedure. A total of 111 subjects received treatment with SB623; 55 subjects were randomized to receive 2.5 million SB623 cells and 56 subjects to receive 5 million SB623 cells.
Arm/Group Title SB623 Implant (2.5M) SB623 Implant (5.0M) Sham Control
Hide Arm/Group Description:

2.5 million SB623 cells

SB623 Implant (2.5M): 2.5 million SB623 cells

5 million SB623 cells

SB623 Implant (5.0M): 5 million SB623 cells

Sham surgery

Sham surgery

Overall Number of Participants Analyzed 55 56 52
Measure Type: Count of Participants
Unit of Measure: Participants
Responder
7
  12.7%
6
  10.7%
5
   9.6%
Non-respinder
39
  70.9%
43
  76.8%
36
  69.2%
Unknown
9
  16.4%
7
  12.5%
11
  21.2%
5.Secondary Outcome
Title Neurological Quality of Life Response: T-scores of the Change From Baseline in the 2 Sub-domains (Upper Extremity Function and Lower Extremity Function)
Hide Description The Neurological Quality of Life (NeuroQOL) was used as a measure of change in the levels of Quality of Life, Satisfaction and Participation, secondary to improvements in the subject's upper and lower extremity motor function. NeuroQOL is summation of item scores for upper extremity (8 terms: score 8 - 40) and lower extremity (8 items: score 8 - 40) separately. The item scores are on a 1 to 5 scale (1 = unable to do; 2 = with much difficulty; 3 = with some difficulty; 4 = with little difficulty; 5 = without any difficulty). The result provided here shows NeuroQOL score converted to T-score. The range for Upper extremity T-score and Lower extremity T-score are 12.8 to 53.8 and 16.5 to 58.6 respectively.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (mITT) Population: Included all randomized subjects who completed the surgery treatment procedure. A total of 111 subjects received treatment with SB623; 55 subjects were randomized to receive 2.5 million SB623 cells and 56 subjects to receive 5 million SB623 cells.
Arm/Group Title SB623 Implant (2.5 M) SB623 Implant (5.0M) Sham Surgery
Hide Arm/Group Description:
2.5 million SB623 cells SB623 Implant (2.5M): 2.5 million SB623 cells
5.0 million SB623 cells SB623 Implant (5.0M): 5.0 million SB623 cells
Sham surgery: Control Group
Overall Number of Participants Analyzed 55 56 52
Least Squares Mean (Standard Error)
Unit of Measure: Change in score on a scale from baseline
Upper Extremity Function 0.14  (2.018) -1.08  (2.000) -0.11  (1.946)
Lower Extremity Function 1.61  (1.343) 2.74  (1.331) 1.60  (1.301)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SB623 Implant (2.5 M), SB623 Implant (5.0M), Sham Surgery
Comments Statistical analysis: NeuroQOL score for the Upper Extremity Function (Represents Mean Change from Baseline in T-Scores at Month 6)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7788
Comments Combined SB623 vs. Sham at month 6 MMRM: Mixed Model for Repeated Measures
Method Mixed Models Analysis
Comments MMRM included treatment, visit, pooled site, corresponding Baseline sub-domain T-score, Baseline mRS score, and the treatment-by-visit interaction
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.36
Confidence Interval (2-Sided) 95%
-2.90 to 2.17
Estimation Comments LSMD (Least square mean difference) (SE): -0.36 (1.283)
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SB623 Implant (2.5 M), SB623 Implant (5.0M), Sham Surgery
Comments Statistical Analysis: NeuroQOL score for Lower Extremity Function (Represents Mean Change from Baseline in T-Scores at Month 6)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5347
Comments Combined SB623 vs. Sham at month 6 MMRM: Mixed Model for Repeated Measures
Method Mixed Models Analysis
Comments MMRM included treatment, visit, pooled site, corresponding Baseline sub-domain T-score, Baseline mRS score, and the treatment-by-visit interaction
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.58
Confidence Interval (2-Sided) 95%
-1.26 to 2.43
Estimation Comments LSMD (Least square mean difference) (SE): 0.58 (0.934)
6.Secondary Outcome
Title Global Rating of Perceived Change (GRPC): The Proportion of Subjects Scoring Either 7 or 6 on the Global Rating of Perceived Change by Both Subject and Clinician
Hide Description

Responders: Participants who scored either 7 [much better] or 6 [a little better, meaningful])

Global Rating of Perceived Change from Baseline: Subjects and Clinicians were asked about perceived changes in their motor function by comparing "how well they are doing compared to before the surgical procedure". The Subject Global Rating of Perceived Change was completed by the subject (or by the caregiver using the subject's answers). The following 7-point Likert scale was used: Score 7 (much better); Score 6 (a little better, meaningful); Score 5 (a little better, not meaningful); Score 4 (about the same); Score 3 (a little worse, not meaningful); Score 2 (a little worse, meaningful); Score 1 (much worse)

Time Frame 6 Months (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (mITT) Population: Included all randomized subjects who completed the surgery treatment procedure. A total of 111 subjects received treatment with SB623; 55 subjects were randomized to receive 2.5 million SB623 cells and 56 subjects to receive 5 million SB623 cells.
Arm/Group Title SB623 Implant (2.5M) SB623 Implant (5.0M) Sham Control
Hide Arm/Group Description:

2.5 million SB623 cells

SB623 Implant (2.5M): 2.5 million SB623 cells

5 million SB623 cells

SB623 Implant (5.0M): 5 million SB623 cells

Sham surgery

Sham surgery

Overall Number of Participants Analyzed 55 56 52
Measure Type: Count of Participants
Unit of Measure: Participants
As per Clinician Responder
15
  27.3%
18
  32.1%
13
  25.0%
Non-responder
39
  70.9%
38
  67.9%
39
  75.0%
Unknown
1
   1.8%
0
   0.0%
0
   0.0%
As per Subject Responder
18
  32.7%
25
  44.6%
22
  42.3%
Non-responder
37
  67.3%
31
  55.4%
30
  57.7%
Unknown
0
   0.0%
0
   0.0%
0
   0.0%
7.Other Pre-specified Outcome
Title Additional Analysis (MMRM), Fugl-Meyer Motor Scale (FMMS)
Hide Description An additional analysis using mixed model for repeated measures (MMRM) was performed treating the change from Baseline in FMMS total score as a continuous outcome (dependent) variable. The independent variables were treatment, visit, treatment-by-visit interaction, and pooled surgical site as effects, and Baseline FMMS total score and Baseline mRS score as covariates. Least-squares means (LS-mean) with SE was calculated for the change from baseline measurements.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (mITT) Population: Included all randomized subjects who completed the surgery treatment procedure. A total of 111 subjects received treatment with SB623; 55 subjects were randomized to receive 2.5 million SB623 cells and 56 subjects to receive 5 million SB623 cells.
Arm/Group Title SB623 Implant (2.5 M) SB623 Implant (5.0M) Sham Surgery
Hide Arm/Group Description:
2.5 million SB623 cells SB623 Implant (2.5M): 2.5 million SB623 cells
5.0 million SB623 cells SB623 Implant (5.0M): 5.0 million SB623 cells
Sham surgery: Control Group
Overall Number of Participants Analyzed 55 56 52
Least Squares Mean (Standard Error)
Unit of Measure: Change in score on a scale from baseline
5.3  (1.64) 4.5  (1.62) 3.6  (1.59)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SB623 Implant (2.5 M), SB623 Implant (5.0M), Sham Surgery
Comments

Change from Baseline at Month 6

Between-group Effect size is calculated as the LS mean difference divided by the model estimate of the pooled SD, obtained from the square root of the diagonal element, associated with the analysis visit summarized, from the covariance matrix.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2959
Comments MMRM: Mixed effect Model Repeat Measurement
Method Mixed Models Analysis
Comments MMRM included treatment, visit, pooled site, corresponding Baseline sub-domain T-score, Baseline mRS score, and the treatment-by-visit interaction
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
-1.1 to 3.6
Estimation Comments LSMD (Least square mean difference) (SE): 1.2 (1.18)
8.Other Pre-specified Outcome
Title Proportion of Subjects Whose FMMS Motor Total Score Improve by ≥10 Points at Month 6 From Baseline (Per Protocol Population)
Hide Description Responders: subjects whose FMMS motor total score improve by ≥10 points at Month 6 from Baseline
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (PP) Population: The PP population included all subjects in the mITT population who did not have important protocol deviations.
Arm/Group Title SB623 Implant (2.5M) SB623 Implant (5.0M) Sham Control
Hide Arm/Group Description:

2.5 million SB623 cells

SB623 Implant (2.5M): 2.5 million SB623 cells

5 million SB623 cells

SB623 Implant (5.0M): 5 million SB623 cells

Sham surgery

Sham surgery

Overall Number of Participants Analyzed 41 46 46
Measure Type: Count of Participants
Unit of Measure: Participants
Responder
6
  14.6%
9
  19.6%
7
  15.2%
Non-responder
34
  82.9%
35
  76.1%
35
  76.1%
Unknown
1
   2.4%
2
   4.3%
4
   8.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SB623 Implant (2.5M), SB623 Implant (5.0M), Sham Control
Comments Combined SB623 Implant Vs Sham Surgery group at Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6854
Comments GLMM: Generalized Linear Mixed Model
Method Mixed Models Analysis
Comments A GLMM with FMMS responder as outcome, treatment, visit, treatment-visit interaction, pooled site, Baseline FMMS and Baseline mRS scores as covariates
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.36
Confidence Interval (2-Sided) 95%
0.31 to 5.92
Estimation Comments [Not Specified]
Time Frame Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SB623 Implant (2.5M) SB623 Implant (5.0M) Sham Control
Hide Arm/Group Description

2.5 million SB623 cells

SB623 Implant (2.5M): 2.5 million SB623 cells

5 million SB623 cells

SB623 Implant (5.0M): 5 million SB623 cells

Control Group: Sham surgery Group
All-Cause Mortality
SB623 Implant (2.5M) SB623 Implant (5.0M) Sham Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)      1/56 (1.79%)      0/52 (0.00%)    
Hide Serious Adverse Events
SB623 Implant (2.5M) SB623 Implant (5.0M) Sham Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/55 (27.27%)      15/56 (26.79%)      10/52 (19.23%)    
Blood and lymphatic system disorders       
Haemorrhagic anaemia   1/55 (1.82%)  1 0/56 (0.00%)  0 0/52 (0.00%)  0
Leukocytosis   0/55 (0.00%)  0 1/56 (1.79%)  1 0/52 (0.00%)  0
Cardiac disorders       
Atrial fibrillation   0/55 (0.00%)  0 1/56 (1.79%)  1 0/52 (0.00%)  0
Pericardial effusion   1/55 (1.82%)  1 0/56 (0.00%)  0 0/52 (0.00%)  0
Ventricular tachycardia   1/55 (1.82%)  1 0/56 (0.00%)  0 0/52 (0.00%)  0
Bradycardia   0/55 (0.00%)  0 0/56 (0.00%)  0 1/52 (1.92%)  1
Ear and labyrinth disorders       
Vertigo   1/55 (1.82%)  1 0/56 (0.00%)  0 0/52 (0.00%)  0
Gastrointestinal disorders       
Nausea   2/55 (3.64%)  2 0/56 (0.00%)  0 0/52 (0.00%)  0
Abdominal pain   1/55 (1.82%)  1 0/56 (0.00%)  0 0/52 (0.00%)  0
Vomiting   1/55 (1.82%)  1 0/56 (0.00%)  0 0/52 (0.00%)  0
Pancreatitis   0/55 (0.00%)  0 0/56 (0.00%)  0 1/52 (1.92%)  1
General disorders       
Pyrexia   0/55 (0.00%)  0 2/56 (3.57%)  2 0/52 (0.00%)  0
Asthenia   0/55 (0.00%)  0 1/56 (1.79%)  1 0/52 (0.00%)  0
Chest pain   1/55 (1.82%)  1 0/56 (0.00%)  0 0/52 (0.00%)  0
Infections and infestations       
Pneumonia   2/55 (3.64%)  3 0/56 (0.00%)  0 0/52 (0.00%)  0
Sepsis   1/55 (1.82%)  2 0/56 (0.00%)  0 1/52 (1.92%)  1
Pancreas infection   0/55 (0.00%)  0 1/56 (1.79%)  1 0/52 (0.00%)  0
Urinary tract infection   0/55 (0.00%)  0 1/56 (1.79%)  1 0/52 (0.00%)  0
Wound infection   1/55 (1.82%)  1 0/56 (0.00%)  0 0/52 (0.00%)  0
Bronchopneumonia   0/55 (0.00%)  0 0/56 (0.00%)  0 1/52 (1.92%)  1
Cellulitis   0/55 (0.00%)  0 0/56 (0.00%)  0 1/52 (1.92%)  1
Influenza   0/55 (0.00%)  0 0/56 (0.00%)  0 1/52 (1.92%)  1
Intervertebral discitis   0/55 (0.00%)  0 0/56 (0.00%)  0 1/52 (1.92%)  1
Staphylococcal osteomyelitis   0/55 (0.00%)  0 0/56 (0.00%)  0 1/52 (1.92%)  1
Injury, poisoning and procedural complications       
Subdural haematoma   3/55 (5.45%)  3 1/56 (1.79%)  1 0/52 (0.00%)  0
Subdural haemorrhage   0/55 (0.00%)  0 2/56 (3.57%)  2 0/52 (0.00%)  0
Contusion   1/55 (1.82%)  1 0/56 (0.00%)  0 0/52 (0.00%)  0
Crush injury   1/55 (1.82%)  1 0/56 (0.00%)  0 0/52 (0.00%)  0
Fall   0/55 (0.00%)  0 1/56 (1.79%)  1 0/52 (0.00%)  0
Hip fracture   0/55 (0.00%)  0 1/56 (1.79%)  1 0/52 (0.00%)  0
Humerus fracture   1/55 (1.82%)  1 0/56 (0.00%)  0 0/52 (0.00%)  0
Incision site complication   1/55 (1.82%)  1 0/56 (0.00%)  0 0/52 (0.00%)  0
Ligament sprain   1/55 (1.82%)  1 0/56 (0.00%)  0 0/52 (0.00%)  0
Pneumocephalus   0/55 (0.00%)  0 1/56 (1.79%)  1 0/52 (0.00%)  0
Upper limb fracture   1/55 (1.82%)  1 0/56 (0.00%)  0 0/52 (0.00%)  0
Wound dehiscence   1/55 (1.82%)  1 0/56 (0.00%)  0 0/52 (0.00%)  0
Investigations       
Anti factor X antibody positive   1/55 (1.82%)  1 0/56 (0.00%)  0 0/52 (0.00%)  0
Metabolism and nutrition disorders       
Hyponatraemia   0/55 (0.00%)  0 1/56 (1.79%)  1 0/52 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Muscle haemorrhage   1/55 (1.82%)  1 0/56 (0.00%)  0 0/52 (0.00%)  0
Rhabdomyolysis   0/55 (0.00%)  0 1/56 (1.79%)  1 0/52 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Bladder cancer   0/55 (0.00%)  0 1/56 (1.79%)  1 0/52 (0.00%)  0
Basal cell carcinoma   0/55 (0.00%)  0 0/56 (0.00%)  0 1/52 (1.92%)  1
Nervous system disorders       
Seizure   4/55 (7.27%)  4 4/56 (7.14%)  5 3/52 (5.77%)  4
Basal ganglia haemorrhage   1/55 (1.82%)  1 0/56 (0.00%)  0 0/52 (0.00%)  0
Generalised tonic-clonic seizure   1/55 (1.82%)  1 0/56 (0.00%)  0 0/52 (0.00%)  0
Seizure like phenomena   1/55 (1.82%)  1 0/56 (0.00%)  0 0/52 (0.00%)  0
Syncope   0/55 (0.00%)  0 1/56 (1.79%)  1 0/52 (0.00%)  0
Encephalopathy   0/55 (0.00%)  0 0/56 (0.00%)  0 1/52 (1.92%)  1
Transient ischaemic attack   0/55 (0.00%)  0 0/56 (0.00%)  0 1/52 (1.92%)  1
Psychiatric disorders       
Suicidal ideation   1/55 (1.82%)  2 0/56 (0.00%)  0 0/52 (0.00%)  0
Renal and urinary disorders       
Renal failure   0/55 (0.00%)  0 1/56 (1.79%)  1 0/52 (0.00%)  0
Urinary retention   1/55 (1.82%)  1 0/56 (0.00%)  0 0/52 (0.00%)  0
Acute kidney injury   0/55 (0.00%)  0 0/56 (0.00%)  0 1/52 (1.92%)  1
Respiratory, thoracic and mediastinal disorders       
Respiratory failure   0/55 (0.00%)  0 0/56 (0.00%)  0 1/52 (1.92%)  1
Vascular disorders       
Hypotension   1/55 (1.82%)  1 0/56 (0.00%)  0 0/52 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SB623 Implant (2.5M) SB623 Implant (5.0M) Sham Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   52/55 (94.55%)      53/56 (94.64%)      51/52 (98.08%)    
Eye disorders       
Eye swelling   3/55 (5.45%)  3 1/56 (1.79%)  1 1/52 (1.92%)  1
Gastrointestinal disorders       
Nausea   13/55 (23.64%)  13 12/56 (21.43%)  12 3/52 (5.77%)  3
Vomiting   10/55 (18.18%)  10 6/56 (10.71%)  6 1/52 (1.92%)  1
Constipation   5/55 (9.09%)  5 2/56 (3.57%)  2 4/52 (7.69%)  5
Diarrhoea   3/55 (5.45%)  3 1/56 (1.79%)  1 1/52 (1.92%)  1
General disorders       
Fatigue   3/55 (5.45%)  3 3/56 (5.36%)  3 4/52 (7.69%)  4
Pyrexia   1/55 (1.82%)  1 3/56 (5.36%)  3 1/52 (1.92%)  1
Pain   0/55 (0.00%)  0 3/56 (5.36%)  3 0/52 (0.00%)  0
Infections and infestations       
Urinary tract infection   2/55 (3.64%)  3 5/56 (8.93%)  5 0/52 (0.00%)  0
Upper respiratory tract infection   0/55 (0.00%)  0 4/56 (7.14%)  5 2/52 (3.85%)  2
Nasopharyngitis   1/55 (1.82%)  1 2/56 (3.57%)  2 3/52 (5.77%)  3
Injury, poisoning and procedural complications       
Procedural headache   8/55 (14.55%)  9 9/56 (16.07%)  9 13/52 (25.00%)  13
Procedural pain   11/55 (20.00%)  11 5/56 (8.93%)  5 6/52 (11.54%)  6
Fall   5/55 (9.09%)  8 5/56 (8.93%)  5 4/52 (7.69%)  12
Incision site pain   5/55 (9.09%)  5 5/56 (8.93%)  5 10/52 (19.23%)  10
Contusion   2/55 (3.64%)  4 3/56 (5.36%)  3 1/52 (1.92%)  1
Skin abrasion   1/55 (1.82%)  1 3/56 (5.36%)  3 2/52 (3.85%)  3
Musculoskeletal and connective tissue disorders       
Back pain   1/55 (1.82%)  1 4/56 (7.14%)  4 1/52 (1.92%)  1
Arthralgia   0/55 (0.00%)  0 4/56 (7.14%)  4 5/52 (9.62%)  5
Nervous system disorders       
Headache   35/55 (63.64%)  42 41/56 (73.21%)  48 32/52 (61.54%)  35
Paraesthesia   1/55 (1.82%)  1 3/56 (5.36%)  4 2/52 (3.85%)  2
Dizziness   0/55 (0.00%)  0 3/56 (5.36%)  5 1/52 (1.92%)  1
Psychiatric disorders       
Depression   6/55 (10.91%)  7 3/56 (5.36%)  3 0/52 (0.00%)  0
Skin and subcutaneous tissue disorders       
Swelling face   2/55 (3.64%)  3 2/56 (3.57%)  2 5/52 (9.62%)  5
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bijan Nejadnik M.D.; Chief Medical Officer
Organization: SanBio, Inc.
Phone: 650-625-2205
EMail: Bijan.Nejadnik@sanbio.com
Layout table for additonal information
Responsible Party: SanBio, Inc.
ClinicalTrials.gov Identifier: NCT02448641    
Other Study ID Numbers: SB-STR02
First Submitted: May 15, 2015
First Posted: May 19, 2015
Results First Submitted: December 20, 2019
Results First Posted: April 17, 2020
Last Update Posted: October 8, 2020