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Dose Escalation Study of AST-OPC1 in Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT02302157
Recruitment Status : Completed
First Posted : November 26, 2014
Results First Posted : July 13, 2021
Last Update Posted : July 14, 2021
Sponsor:
Information provided by (Responsible Party):
Lineage Cell Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cervical Spinal Cord Injury
Spine Injury
Spinal Cord Trauma
Intervention Biological: AST-OPC1
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AST-OPC1, Cohort 1 AST-OPC1, Cohort 2 AST-OPC1, Cohort 3 AST-OPC1, Cohort 4 AST-OPC1, Cohort 5
Hide Arm/Group Description n=3 subjects Dosage of 2 million cells AIS score A n=6 subjects Dosage 10 million cells AIS score A n=6 subjects Dosage of 20 million cells AIS score A n=6 subjects Dosage of 10 million AIS score B n=4 subjects Dosage of 20 million cells AIS score B
Period Title: Overall Study
Started 3 6 6 6 4
Completed 3 6 6 6 4
Not Completed 0 0 0 0 0
Arm/Group Title AST-OPC1, Cohort 1 AST-OPC1, Cohort 2 AST-OPC1, Cohort 3 AST-OPC1, Cohort 4 AST-OPC1, Cohort 5 Total
Hide Arm/Group Description n=3 Dosage of 2 million cells AIS score A n=6 Dosage of 10 million cells AIS score A n=6 Dosage of 20 million cells AIS score A n=6 Dosage of 10 million cells AIS score B n=4 Dosage of 20 million cells AIS score B Total of all reporting groups
Overall Number of Baseline Participants 3 6 6 6 4 25
Hide Baseline Analysis Population Description
The baseline characteristics and demographic are described separately by each cohorts per Age, gender, race, height, weight, BMI
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 6 participants 6 participants 6 participants 4 participants 25 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
4
 100.0%
25
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 6 participants 6 participants 6 participants 4 participants 25 participants
24.3  (6.1) 24.5  (7.4) 44.7  (14.7) 28.5  (14.1) 34.3  (20.7) 30.8  (14.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 6 participants 6 participants 6 participants 4 participants 25 participants
Female
0
   0.0%
1
  16.7%
1
  16.7%
0
   0.0%
2
  50.0%
4
  16.0%
Male
3
 100.0%
5
  83.3%
5
  83.3%
6
 100.0%
2
  50.0%
21
  84.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 6 participants 6 participants 6 participants 4 participants 25 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
1
   4.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
1
   4.0%
Black or African American
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.0%
White
3
 100.0%
5
  83.3%
6
 100.0%
6
 100.0%
2
  50.0%
22
  88.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 6 participants 6 participants 6 participants 4 participants 25 participants
3 6 6 6 4 25
The Abbreviated Injury Scale (AIS)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 6 participants 6 participants 6 participants 4 participants 25 participants
3
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
4
 100.0%
25
 100.0%
1.Primary Outcome
Title Number of Adverse Events Within 1 Year (365 Days) That Are Related to AST-OPC1 Injection
Hide Description Numbers of adverse events within 1 year (365 days) that are related to AST-OPC1 injection
Time Frame One Year
Hide Outcome Measure Data
Hide Analysis Population Description
All 25 subject experienced at least one (1) AEs. The population description described on comment [1] above.
Arm/Group Title AST-OPC1, Cohort 1 AST-OPC1, Cohort 2 AST-OPC1, Cohort 3 AST-OPC1, Cohort 4 AST-OPC1, Cohort 5
Hide Arm/Group Description:
n=3 Dosage of 2 million cells AIS score A
n=6 Dosage of 10 million cells AIS score A
n=6 Dosage of 20 million cells AIS score A
n=6 Dosage of 10 million cells AIS score B
n=4 Dosage of 20 million cells AIS score B
Overall Number of Participants Analyzed 3 6 6 6 4
Measure Type: Number
Unit of Measure: Adverse Events
92 122 133 118 69
2.Secondary Outcome
Title Neurological Function as Measured by Upper Extremity Motor Scores and Motor Level on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examinations as Secondary End Point - 365 Days After Injection of AST-OPC1
Hide Description

The scale is based on the ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury) that measures the severity of Spinal cord injury. The data was collected per time point during the first year (30,60,90,180,270,365). The 365-days time point was pre-specified as Secondary Outcome Measure. High score means better outcome. Units are "Scores on a scale".

The score is divided to motor scale (0-100) and sensor scale (0-224).

Motor scale is divided to subscale of upper extremity (0-50) and lower extremity (0-50).

Upper and lower extremity are divided to subscale of Right (0-25) + Left (0-25).

Each upper & lower extremity is divided to subscale of 5 motor nerve function (0-5).

Sensor scale is divided to subscale of light touch (0-112) and pin prick (0-112).

light touch and pin prick are divided to subscales of Right (0-56) + Left (0-56).

Each right and left light touch and pin prick are divided to subscales of 28 sensor nerve function (0-2)

Time Frame One Year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AST-OPC1, Cohort 1 AST-OPC1, Cohort 2 AST-OPC1, Cohort 3 AST-OPC1, Cohort 4 AST-OPC1, Cohort 5
Hide Arm/Group Description:
n=3 Dosage of 2 million AIS A
n=6 Dosage of 10 million AIS A
n=6 Dosage of 20 million AIS A
n=6 Dosage of 10 million AIS B
n=4 Dosage of 20 million AIS B
Overall Number of Participants Analyzed 3 6 6 6 4
Mean (Full Range)
Unit of Measure: Score on a scale
UEMS (Upper Extremities Motor Scale) - Baseline
19
(0 to 50)
21
(0 to 50)
17
(0 to 50)
22
(0 to 50)
18
(0 to 50)
UEMS (Upper Extremities Motor Scale) - Day 365
24
(0 to 50)
34
(0 to 50)
26
(0 to 50)
28
(0 to 50)
24
(0 to 50)
LEMS (Lower Extremities Motor Scale) - Baseline
0
(0 to 50)
0
(0 to 50)
0
(0 to 50)
0
(0 to 50)
0
(0 to 50)
LEMS (Lower Extremities Motor Scale) - Day 365
0
(0 to 50)
0
(0 to 50)
0
(0 to 50)
1
(0 to 50)
1
(0 to 50)
LT (Light Touch) - Baseline
21
(0 to 112)
27
(0 to 112)
22
(0 to 112)
35
(0 to 112)
53
(0 to 112)
LT (Light Touch) - Day 365
21
(0 to 112)
32
(0 to 112)
31
(0 to 112)
46
(0 to 112)
65
(0 to 112)
PP (Pin Prick) - Baseline
22
(0 to 112)
23
(0 to 112)
19
(0 to 112)
25
(0 to 112)
22
(0 to 112)
PP (Pin Prick) - Day 365
20
(0 to 112)
25
(0 to 112)
21
(0 to 112)
28
(0 to 112)
34
(0 to 112)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AST-OPC1, Cohort 1 AST-OPC1, Cohort 2 AST-OPC1, Cohort 3 AST-OPC1, Cohort 4 AST-OPC1, Cohort 5
Hide Arm/Group Description n=3 Dosage of 2 million cells AIS score A n=6 Dosage of 10 million cells AIS score A n=6 Dosage of 20 million cells AIS score A n=6 Dosage of 10 million cells AIS score B n=4 Dosage of 20 million cells AIS score B
All-Cause Mortality
AST-OPC1, Cohort 1 AST-OPC1, Cohort 2 AST-OPC1, Cohort 3 AST-OPC1, Cohort 4 AST-OPC1, Cohort 5
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/4 (0.00%)    
Hide Serious Adverse Events
AST-OPC1, Cohort 1 AST-OPC1, Cohort 2 AST-OPC1, Cohort 3 AST-OPC1, Cohort 4 AST-OPC1, Cohort 5
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/3 (66.67%)      2/6 (33.33%)      4/6 (66.67%)      2/6 (33.33%)      1/4 (25.00%)    
Blood and lymphatic system disorders           
Hypokalemia  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0
Cardiac disorders           
Atrial Fibrillation  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1
Gastrointestinal disorders           
Bilateral Decubitus Ulcers  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0
Gastrointestinal Bleeding  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0
General disorders           
Altered Mental Status  1  0/3 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0 0/4 (0.00%)  0
Infections and infestations           
Aspiration Pneumonia  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0
Bilateral Pyelonephritis due to UTI  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0
Buttock Abscess  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0
Escherichia Coli Urinary Sepsis  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0
Infected Epidural Fluid  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0
Sepsis  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0
Urosepsis  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0
Urinary Tract Infection (UTI)  1  2/3 (66.67%)  2 1/6 (16.67%)  1 2/6 (33.33%)  2 2/6 (33.33%)  2 0/4 (0.00%)  0
Wound Infection  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0
Injury, poisoning and procedural complications           
Cerebrospinal Fluid Leak  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Bilateral Hip Effusions  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0
Left Femoral Shaft Fracture  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0
Renal and urinary disorders           
Acute Renal Failure  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0
Non-Traumatic Kidney Injury  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1
Respiratory, thoracic and mediastinal disorders           
Acute respiratory failure  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0
Vascular disorders           
Pulmonary Embolism  1  0/3 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0 0/4 (0.00%)  0
1
Term from vocabulary, MedDRA (18.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AST-OPC1, Cohort 1 AST-OPC1, Cohort 2 AST-OPC1, Cohort 3 AST-OPC1, Cohort 4 AST-OPC1, Cohort 5
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/4 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Avi Ben Shabat, MD
Organization: Lineage
Phone: +972-509105205
EMail: avi@cellcure.co.il
Layout table for additonal information
Responsible Party: Lineage Cell Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02302157    
Other Study ID Numbers: AST-OPC1-01
First Submitted: November 24, 2014
First Posted: November 26, 2014
Results First Submitted: December 15, 2020
Results First Posted: July 13, 2021
Last Update Posted: July 14, 2021