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

Phase 2

Terminated

• Conditions: Posterior Cerebral Artery Stroke; Stroke, Acute; Middle Cerebral Artery Stroke
• Interventions: Biological: Human Placenta-Derived Cells PDA001- (cenplacel-L); Drug: Placebo

• Registration Number: NCT01310114
• Lead Sponsor: Celularity Incorporated

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 Description

Not available

Study Timeline

• Study First Submitted: 2011-02-25
• Study Start: 2011-03
• Study First Submitted QC: 2011-03-04
• Study First Posted: 2011-03-08
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Disposition First Submitted: 2013-08-12
• Disposition First Submitted QC: 2013-08-12
• Disposition First Posted: 2013-08-21
• Status Verified: 2016-03
• Last Update Submitted: 2018-02-27
• Last Update Posted: 2018-03-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2B - Experimental	Placebo	4 units PDA001 \[approximately 8 x 108 cells\] or placebo in 240 mL per infusion on Day 1
Cohort 1	Human Placenta-Derived Cells PDA001- (cenplacel-L)	1 unit PDA001 \[approximately 2 x 108 cells\] in 240 mL per infusion on Day 1.
Cohort 2A - Experimental	Human Placenta-Derived Cells PDA001- (cenplacel-L)	1 unit PDA001 \[approximately 2 x 108 cells\] or placebo in 240 mL per infusion on Day 1
Cohort 2A - Experimental	Placebo	1 unit PDA001 \[approximately 2 x 108 cells\] or placebo in 240 mL per infusion on Day 1
Cohort 2B - Experimental	Human Placenta-Derived Cells PDA001- (cenplacel-L)	4 units PDA001 \[approximately 8 x 108 cells\] or placebo in 240 mL per infusion on Day 1

Primary Outcome Measures

Name	Time	Method
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	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	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)	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 Outcome Measures

Name	Time	Method
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	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)	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)	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.

Trial Locations

Locations (1)

Chattanooga Center for Neurologic Research; 🇺🇸 Chattanooga, Tennessee, United States