A Phase 2A, Prospective, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults Following Ischemic Stroke
Overview
- Phase
- Phase 2
- Intervention
- Human Placenta-Derived Cells PDA001- (cenplacel-L)
- Conditions
- Stroke, Acute
- Sponsor
- Celularity Incorporated
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Clinical response defined by a ≥ 1 point decrease from baseline in the Modified Rankin Scale (mRS) at Day 91 post treatment
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief Summary
The primary objective of the study is to assess the safety and tolerability of Human Placenta-Derived Cells (PDA001) at 3 different dose levels versus placebo (vehicle control) administered intravenously in subjects following ischemic stroke. The secondary objective of the study is to assess the effect of PDA001 on improvement in clinical function following ischemic stroke.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Cohort 1
1 unit PDA001 \[approximately 2 x 108 cells\] in 240 mL per infusion on Day 1.
Intervention: Human Placenta-Derived Cells PDA001- (cenplacel-L)
Cohort 2A - Experimental
1 unit PDA001 \[approximately 2 x 108 cells\] or placebo in 240 mL per infusion on Day 1
Intervention: Human Placenta-Derived Cells PDA001- (cenplacel-L)
Cohort 2A - Experimental
1 unit PDA001 \[approximately 2 x 108 cells\] or placebo in 240 mL per infusion on Day 1
Intervention: Placebo
Cohort 2B - Experimental
4 units PDA001 \[approximately 8 x 108 cells\] or placebo in 240 mL per infusion on Day 1
Intervention: Human Placenta-Derived Cells PDA001- (cenplacel-L)
Cohort 2B - Experimental
4 units PDA001 \[approximately 8 x 108 cells\] or placebo in 240 mL per infusion on Day 1
Intervention: Placebo
Outcomes
Primary Outcomes
Clinical response defined by a ≥ 1 point decrease from baseline in the Modified Rankin Scale (mRS) at Day 91 post treatment
Time Frame: Baseline to 91 days
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of participants who have suffered a stroke or other causes of neurological disability, and it has become the most widely used clinical outcome measure for stroke clinical trials. The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1 - No significant disability. Able to carry out all usual activities, despite some symptoms. 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.
Clinical response defined by a ≥ 1 point decrease from baseline in the Modified Rankin Scale (mRS) at Day 181 post treatment
Time Frame: 181 days
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of participants who have suffered a stroke or other causes of neurological disability, and it has become the most widely used clinical outcome measure for stroke clinical trials. The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1 - No significant disability. Able to carry out all usual activities, despite some symptoms. 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.
Safety (Type, frequency, severity and potential relationship to study drug of adverse events)
Time Frame: Up to 24 months
A Treatment-emergent AE was any AE that began or worsened in grade after the start of study drug through 30 days after the last dose of study drug or end of study whichever is later. Treatment related toxicity was one considered by the investigator to be possibly, probably or definitely related to study drug. AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death. A serious adverse event (SAE) is any AE occurring at any dose that: results in death; is fatal or life-threatening; results in persistent or significant disability or incapacity; requires or prolongs in-patient hospitalization; is a congenital anomaly/birth defect in the offspring of a patient; and constitutes an important medical event.
Secondary Outcomes
- Clinical response defined by a ≥ 1 point decrease from baseline in the Modified Rankin Scale (mRS) at 24 months post treatment(Up to 24 months)
- Clinical response defined as a ≥ 4 point decrease from baseline in the National Institute of Health Stroke Scale (NIHSS)(Up to 24 months)
- Clinical response defined as a clinically significant improvement (at least 20-point increase from baseline) in the Barthel Index (BI)(Up to 24 months)