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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: 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 t

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.

Detailed Summary:
Sponsor: Celgene Corporation

Current Primary Outcome:

  • 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.
  • 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

    Original Primary Outcome:

    • Safety [ Time Frame: Up to 24 months ]
      Number of participants with adverse events
    • Efficacy - Clinical Response [ Time Frame: 91 days ]
      Clinical response defined by a ≥ 1 point decrease from baseline in the Modified Rankin Scale (mRS)
    • Efficacy - Clinical Response [ Time Frame: 181 days ]
      Clinical response defined by a ≥ 1 point decrease from baseline in the Modified Rankin Scale (mRS)


    Current Secondary Outcome:

    • Clinical response defined by a ≥ 1 point decrease from baseline in the Modified Rankin Scale (mRS) at 24 months post treatment [ Time Frame: Up to 24 months ]
      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 as a ≥ 4 point decrease from baseline in the National Institute of Health Stroke Scale (NIHSS) [ Time Frame: Up to 24 months ]

      The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.[1] The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.

      Score Stroke Severity:

      0 No Stroke Symptoms 1-4 Minor Stroke 5-15 Moderate Stroke 16-20 Moderate to Severe Stroke 21-42 Severe Stroke

    • Clinical response defined as a clinically significant improvement (at least 20-point increase from baseline) in the Barthel Index (BI) [ Time Frame: Up to 24 months ]
      The Barthel Index (BI) measures the extent to which a person can function independently and has mobility in their activities of daily living (ADL) ie feeding, bathing, groomig, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. The index also indicates the need for assistance in care. Total possible scores range from 0 - 20, with lower scores indicating increased disability. If used to measure improvement after rehabilitation, changes of more than two points in the total score reflect a probable genuine change, and change on one item from fully dependent to independent is also likely to be reliable.


    Original Secondary Outcome:

    • Efficacy - Clinical Response [ Time Frame: Up to 24 months ]
      Clinical response defined by a ≥ 1 point decrease from baseline in the Modified Rankin Scale (mRS)
    • Efficacy - Clinical response [ Time Frame: Up to 24 months ]
      Clinical response defined as a ≥ 4 point decrease from baseline in the National Institute of Health Stroke Scale (NIHSS)
    • Efficacy - Clinical response [ Time Frame: Up to 24 months ]
      Clinical response defined as a clinically significant improvement (at least 20-point increase from baseline) in the Barthel Index (BI)


    Information By: Celgene Corporation

    Dates:
    Date Received: February 25, 2011
    Date Started: March 2011
    Date Completion:
    Last Updated: March 30, 2016
    Last Verified: March 2016