Study of Human Placenta-derived Cells (PDA001) to Evaluate the Safety and Effectiveness for Patients With Ischemic Stroke

Terminated

Phase 2 Results N/A

Trial Description

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.

Trial Stopped: Study terminated by sponsor

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Thawed placebo
    ARM 1: Kind: Experimental
    Label: Cohorts 2A and 2B - Placebo
    Description: 5 subjects will receive placebo (vehicle control) on Day 1 and Day 8
    ARM 2: Kind: Experimental
    Label: Cohort 2A - Experimental
    Description: 15 subjects will receive 1 unit PDA001 [approximately 2 x 108 cells] in 240 mL per infusion on Day 1 and Day 8.
    ARM 3: Kind: Experimental
    Label: Cohort 2B - Experimental
    Description: 15 subjects will receive 4 units PDA001 [approximately 8 x 108 cells] in 240 mL per infusion on Day 1 and Day 8.
    ARM 4: Kind: Experimental
    Label: Cohorts 2A and 2B - Placebo
    Description: 5 subjects will receive placebo (vehicle control) on Day 1 and Day 8
  • Human Placenta-Derived Cells PDA001- (cenplacel-L) Biological
    Intervention Desc: 240 mL of intravenous infusion
    ARM 1: Kind: Experimental
    Label: Cohort 1
    Description: 4 subjects will receive 1 unit PDA001 [approximately 2 x 108 cells] in 240 mL per infusion on Day 1.
    ARM 2: Kind: Experimental
    Label: Cohort 2A - Experimental
    Description: 15 subjects will receive 1 unit PDA001 [approximately 2 x 108 cells] in 240 mL per infusion on Day 1 and Day 8.
    ARM 3: Kind: Experimental
    Label: Cohort 2B - Experimental
    Description: 15 subjects will receive 4 units PDA001 [approximately 8 x 108 cells] in 240 mL per infusion on Day 1 and Day 8.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Safety Up to 24 months Yes
Primary Efficacy - Clinical Response 91 days No
Primary Safety (Type, frequency, severity and potential relationship to study drug of adverse events) Up to 24 months Yes
Primary Clinical response defined by a ≥ 1 point decrease from baseline in the Modified Rankin Scale (mRS) at Day 91 post treatment Baseline to 91 days No
Primary Clinical response defined by a ≥ 1 point decrease from baseline in the Modified Rankin Scale (mRS) at Day 181 post treatment 181 days No
Secondary 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 No
Secondary Clinical response defined as a ≥ 4 point decrease from baseline in the National Institute of Health Stroke Scale (NIHSS) Up to 24 months No
Secondary Clinical response defined as a clinically significant improvement (at least 20-point increase from baseline) in the Barthel Index (BI) Up to 24 months No

Sponsors