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The purpose of this study is to evaluate the safety of cross sequential escalating doses of AST-OPC1 administered among 5 cohorts at a single time-point between 21 and 42 days post injury, inclusively, to subjects with subacute cervical spinal cord injuries (SCI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AST-OPC1 | Experimental | Open label, dose escalation, cross-sequential cohort of subjects who receive an injection or two injections of AST-OPC1 at a single time-point |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AST-OPC1 | Biological | One injection of 2 million or 10 million AST-OPC1 cells, or 2 injections of 10 million AST-OPC1 cells for a total of 20 million cells; cohort dependent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events Within 1 Year (365 Days) That Are Related to AST-OPC1 Injection | Numbers of adverse events within 1 year (365 days) that are related to AST-OPC1 injection | One Year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) |
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Major Inclusion Criteria:
Major Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward D Wirth III, MD, PhD | Asterias Biotherapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ. of California at San Diego | La Jolla | California | 92093 | United States | ||
| Rancho Los Amigos/USC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35901693 | Derived | Fessler RG, Ehsanian R, Liu CY, Steinberg GK, Jones L, Lebkowski JS, Wirth ED, McKenna SL. A phase 1/2a dose-escalation study of oligodendrocyte progenitor cells in individuals with subacute cervical spinal cord injury. J Neurosurg Spine. 2022 Jul 8;37(6):812-820. doi: 10.3171/2022.5.SPINE22167. Print 2022 Dec 1. | |
| 35364569 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | AST-OPC1, Cohort 1 | n=3 subjects Dosage of 2 million cells AIS score A |
| FG001 | AST-OPC1, Cohort 2 | n=6 subjects Dosage 10 million cells AIS score A |
| FG002 | AST-OPC1, Cohort 3 | n=6 subjects Dosage of 20 million cells AIS score A |
| FG003 | AST-OPC1, Cohort 4 | n=6 subjects Dosage of 10 million AIS score B |
| FG004 | AST-OPC1, Cohort 5 | n=4 subjects Dosage of 20 million cells AIS score B |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The baseline characteristics and demographic are described separately by each cohorts per Age, gender, race, height, weight, BMI
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| ID | Title | Description |
|---|---|---|
| BG000 | AST-OPC1, Cohort 1 | n=3 Dosage of 2 million cells AIS score A |
| BG001 | AST-OPC1, Cohort 2 | n=6 Dosage of 10 million cells AIS score A |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Adverse Events Within 1 Year (365 Days) That Are Related to AST-OPC1 Injection | Numbers of adverse events within 1 year (365 days) that are related to AST-OPC1 injection | All 25 subject experienced at least one (1) AEs. The population description described on comment [1] above. | Posted | Number | Adverse Events | One Year |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AST-OPC1, Cohort 1 | n=3 Dosage of 2 million cells AIS score A | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Renal Failure | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
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Open label study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Avi Ben Shabat, MD | Lineage | +972-509105205 | avi@cellcure.co.il |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 7, 2017 | Dec 3, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 3, 2018 | Dec 3, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D013124 | Spinal Injuries |
| D013119 | Spinal Cord Injuries |
| D010243 | Paralysis |
| D011782 | Quadriplegia |
| ID | Term |
|---|---|
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
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| One Year |
| Los Angeles |
| California |
| United States |
| Stanford University/Santa Clara Valley Medical Center | San Jose | California | 95128 | United States |
| Shepherd Center | Atlanta | Georgia | 30309 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Thomas Jefferson University/Magee Rehabilitation | Philadelphia | Pennsylvania | 19107 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| McKenna SL, Ehsanian R, Liu CY, Steinberg GK, Jones L, Lebkowski JS, Wirth E, Fessler RG. Ten-year safety of pluripotent stem cell transplantation in acute thoracic spinal cord injury. J Neurosurg Spine. 2022 Apr 1;37(3):321-330. doi: 10.3171/2021.12.SPINE21622. Print 2022 Sep 1. |
| BG002 | AST-OPC1, Cohort 3 | n=6 Dosage of 20 million cells AIS score A |
| BG003 | AST-OPC1, Cohort 4 | n=6 Dosage of 10 million cells AIS score B |
| BG004 | AST-OPC1, Cohort 5 | n=4 Dosage of 20 million cells AIS score B |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| The Abbreviated Injury Scale (AIS) | Count of Participants | Participants |
|
| AST-OPC1, Cohort 3 |
n=6 Dosage of 20 million cells AIS score A |
| OG003 | AST-OPC1, Cohort 4 | n=6 Dosage of 10 million cells AIS score B |
| OG004 | AST-OPC1, Cohort 5 | n=4 Dosage of 20 million cells AIS score B |
|
|
| Secondary | 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 | 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) | Posted | Mean | Full Range | Score on a scale | One Year |
|
|
|
| 3 |
| 2 |
| 3 |
| 0 |
| 3 |
| EG001 | AST-OPC1, Cohort 2 | n=6 Dosage of 10 million cells AIS score A | 0 | 6 | 2 | 6 | 0 | 6 |
| EG002 | AST-OPC1, Cohort 3 | n=6 Dosage of 20 million cells AIS score A | 0 | 6 | 4 | 6 | 0 | 6 |
| EG003 | AST-OPC1, Cohort 4 | n=6 Dosage of 10 million cells AIS score B | 0 | 6 | 2 | 6 | 0 | 6 |
| EG004 | AST-OPC1, Cohort 5 | n=4 Dosage of 20 million cells AIS score B | 0 | 4 | 1 | 4 | 0 | 4 |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Altered Mental Status | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Aspiration Pneumonia | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
|
| Bilateral Decubitus Ulcers | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Bilateral Hip Effusions | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Bilateral Pyelonephritis due to UTI | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Buttock Abscess | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Cerebrospinal Fluid Leak | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Escherichia Coli Urinary Sepsis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Gastrointestinal Bleeding | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Hypokalemia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Infected Epidural Fluid | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Left Femoral Shaft Fracture | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Non-Traumatic Kidney Injury | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
|
| Pulmonary Embolism | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Urinary Tract Infection (UTI) | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Wound Infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
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| D009422 |
| Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| UEMS (Upper Extremities Motor Scale) - Day 365 |
|
| LEMS (Lower Extremities Motor Scale) - Baseline |
|
| LEMS (Lower Extremities Motor Scale) - Day 365 |
|
| LT (Light Touch) - Baseline |
|
| LT (Light Touch) - Day 365 |
|
| PP (Pin Prick) - Baseline |
|
| PP (Pin Prick) - Day 365 |
|