Stroke, AcutePhase 2NCT01310114
Study of Human Placenta-derived Cells (PDA001) to Evaluate the Safety and Effectiveness for Patients With Ischemic Stroke
A Phase 2 study testing Human Placenta-Derived Cells PDA001- (cenplacel-L) in people with Stroke, Acute and Middle Cerebral Artery Stroke, run by Celularity Incorporated at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Acute, Middle Cerebral Artery Stroke, Posterior Cerebral Artery Stroke
- What is being tested?
- Human Placenta-Derived Cells PDA001- (cenplacel-L)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Mar 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females 18 years of age to 80 years of age at the time of signing of the informed consent document.
- Subject or subject's legal representative must understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures being conducted.
- Able to adhere to the study visit schedule and other protocol requirements.
- A female of childbearing potential (FCBP) must have a negative serum or urine pregnancy test within 48 ± 24 hours prior to treatment with study therapy. In addition, sexually active FCBP must agree to use two of the following adequate forms of contraception methods simultaneously such as: oral, injectable or implantable hormonal contraception; tubal ligation; intrauterine device; barrier contraceptive with spermicide; or vasectomized partner for the duration of the study and the follow-up period. Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with FCBP for the duration of the study and the follow-up period.
- Diagnosis of stroke involving the middle cerebral artery (MCA) territory (cortical and subcortical) or posterior cerebral artery (PCA) (PCA is limited to 3 subjects per cohort) ischemic stroke confirmed by magnetic resonance imaging (MRI)/ computerized tomography (CT). An ischemic stroke is death of an area of brain tissue (cerebral infarction) resulting from an inadequate supply of blood and oxygen to the brain.
- National Institute of Health Stroke Scale (NIHSS) score of ≥ 6 but < 20 at the time of screening and infusion. Subject should not have shown rapid improvement (≥ 8 point decrease) or deterioration (≥ 4 point increase) in the score from time of initial evaluation to pre-infusion. To the extent possible, the time from initial screening evaluation to reevaluation will be at least 24 hours.
- Subject must have had a normal neurologic status prior to ischemic episode defined as the absence of focal or global central neurological or psychiatric deficits of sufficient magnitude that it could not reasonably be expected that the subject could recover to the normal range based on the instruments used to assess the subject's response to treatment. The pre-stroke modified Rankin score should be between 0 and 2 inclusive.
- Treatment with tissue plasminogen activator (tPA) or Food and Drug Administration (FDA)-approved devices used to restore circulation are allowed but treatment must be completed at least 24 hours prior to administration of PDA001.
Who cannot join
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject or subject's legal representative from signing the informed consent form.
- Pregnant or lactating females.
- Any condition, including any medical or neuropsychiatric condition, including the presence of laboratory abnormalities, which in the judgment of the investigator places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study including (but not limited to):
- Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT ) > 2.5 x the upper limit of normal at screening.
- Serum creatinine concentration >1.5 times the upper limit of normal at screening.
- Bilirubin or alkaline phosphatase level > 2.5 x the upper limit of normal at screening.
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- Glucose < 50 mg/dL or > 250 mg/dL despite adequate antihyperglycemic treatment.
- Platelet count < 100 x 109 per liter.
- History of bacteremia or other serious bacterial or fungal infection requiring treatment with IV antibiotics within 84 days (12 weeks) prior to treatment with study therapy other than a treated urinary tract infection.
- Known infection with human immunodeficiency virus (HIV).
- Seropositive for hepatitis C or hepatitis B.
- Known history of seizures.
- Severe heart failure or evidence of acute myocardial infarction defined of having at least two of the following three features: (1) Chest pain suggestive of cardiac ischemia; (2)Electrocardiogram (ECG) findings of ST elevation of greater than 0.2 mV in 2 contiguous leads, new onset left bundle branch block, ST segment depression, or T-wave inversion; (3) Elevated troponin I. History of prior myocardial infarction within the previous 6 months.
- Evidence of prior cerebral hemorrhage or ischemic stroke within the last 3 months or recent intracerebral hematomas by head CT or MRI. This exclusion does not include clinically insignificant petechial hemorrhages.
- Subjects with only lacunar infarcts on MRI or CT. A lacunar infarct is defined as a small (0.2 to 15 mm in diameter) noncortical infarct caused by occlusion of a single penetrating branch of a large cerebral artery.
- Persistent hypertension with systolic blood pressure (BP) greater than 185 mmHg or diastolic BP greater than 110 mmHg (mean of 3 consecutive arm cuff readings over 20-30 minutes), not controlled by antihypertensive therapy or requiring nitroprusside for control. Efforts should be made to bring systolic blood pressure (BP) to ≤ 160 or diastolic BP ≤ 100 mmHg at the time of IP administration.
- Clinically significant pulmonary dysfunction, including severe chronic obstructive pulmonary disease (COPD) and history of lung resection.
- High clinical suspicion of septic embolus.
- History of pulmonary emboli or deep vein thrombus
- History of major trauma at time of stroke
- History of malignancy within 5 years except basal cell or squamous cell carcinoma of the skin or remote history of cancer now considered cured or positive Pap smear with subsequent negative follow up.
- Known allergy to bovine or porcine products.
- Known allergy to both gadolinium and iodine based contrast agents for MRI or CT scan preventing the ability to conduct either one of these procedures.
- Subject has received an investigational agent -an agent or device not approved by FDA for marketed use in any indication-within 90 days (or 5 half-lives, whichever is longer) prior to treatment with study therapy or planned participation in another therapeutic trial prior to the completion of this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Chattanooga Center for Neurologic Research
Chattanooga, Tennessee, 37403
About this study
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 the Treatment of Adults Following Ischemic Stroke
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.
- Being tested
- Human Placenta-Derived Cells PDA001- (cenplacel-L), Placebo
- Keywords
- Human Placenta-Derived Cells, Stem cells, Stroke, PDA001, Celgene, cenplacel-L
- Medical subject headings
- Stroke, Infarction, Middle Cerebral Artery, Infarction, Posterior Cerebral Artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Placenta-Derived Cells PDA001- (cenplacel-L)Biological
240 mL of intravenous infusion
PlaceboDrug
Thawed placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 1 unit PDA001 [approximately 2 x 108 cells] in 240 mL per infusion on Day 1. Receives: Biological: Human Placenta-Derived Cells PDA001- (cenplacel-L) |
| Cohort 2A - Experimental | Experimental | 1 unit PDA001 [approximately 2 x 108 cells] or placebo in 240 mL per infusion on Day 1 Receives: Biological: Human Placenta-Derived Cells PDA001- (cenplacel-L); Drug: Placebo |
| Cohort 2B - Experimental | Experimental | 4 units PDA001 [approximately 8 x 108 cells] or placebo in 240 mL per infusion on Day 1 Receives: Biological: Human Placenta-Derived Cells PDA001- (cenplacel-L); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (Type, frequency, severity and potential relationship to study drug of adverse events)
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.
Measured: Up to 24 months
Clinical response defined by a ≥ 1 point decrease from baseline in the Modified Rankin Scale (mRS) at Day 91 post treatment
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.
Measured: Baseline to 91 days
Clinical response defined by a ≥ 1 point decrease from baseline in the Modified Rankin Scale (mRS) at Day 181 post treatment
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.
Measured: 181 days
Secondary outcomes (3)
Clinical response defined by a ≥ 1 point decrease from baseline in the Modified Rankin Scale (mRS) at 24 months post treatment
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
Measured: Up to 24 months
Clinical response defined as a ≥ 4 point decrease from baseline in the National Institute of Health Stroke Scale (NIHSS)
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
Measured: Up to 24 months
Clinical response defined as a clinically significant improvement (at least 20-point increase from baseline) in the Barthel Index (BI)
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.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Study terminated by sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celularity Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Monica E Luchi, MD, Study director, Celularity Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310114
- Sponsor's protocol ID
- CCT-PDA001-SK-001
- Status last verified
- Mar 2016
- First submitted
- 25 Feb 2011
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 the Treatment of Adults Following Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01310114
- Acronym / sponsor ID
- CCT-PDA001-SK-001
- Keywords
- Human Placenta-Derived Cells, Stem cells, Stroke, PDA001, Celgene, cenplacel-L
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated by sponsor
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Celularity IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- Celgene Corporation
- Study start
- Mar 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 8 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: 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 | Experimental | Biological: Human Placenta-Derived Cells PDA001- (cenplacel-L), Drug: Placebo1 unit PDA001 [approximately 2 x 108 cells] or placebo in 240 mL per infusion on Day 1 |
| Cohort 2B - Experimental | Experimental | Biological: Human Placenta-Derived Cells PDA001- (cenplacel-L), Drug: Placebo4 units PDA001 [approximately 8 x 108 cells] or placebo in 240 mL per infusion on Day 1 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and females 18 years of age to 80 years of age at the time of signing of the informed consent document.
- Subject or subject's legal representative must understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures being conducted.
- Able to adhere to the study visit schedule and other protocol requirements.
- A female of childbearing potential (FCBP) must have a negative serum or urine pregnancy test within 48 ± 24 hours prior to treatment with study therapy. In addition, sexually active FCBP must agree to use two of the following adequate forms of contraception methods simultaneously such as: oral, injectable or implantable hormonal contraception; tubal ligation; intrauterine device; barrier contraceptive with spermicide; or vasectomized partner for the duration of the study and the follow-up period. Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with FCBP for the duration of the study and the follow-up period.
- Diagnosis of stroke involving the middle cerebral artery (MCA) territory (cortical and subcortical) or posterior cerebral artery (PCA) (PCA is limited to 3 subjects per cohort) ischemic stroke confirmed by magnetic resonance imaging (MRI)/ computerized tomography (CT). An ischemic stroke is death of an area of brain tissue (cerebral infarction) resulting from an inadequate supply of blood and oxygen to the brain.
Key exclusion criteria (24 listed)
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject or subject's legal representative from signing the informed consent form.
- Pregnant or lactating females.
- Any condition, including any medical or neuropsychiatric condition, including the presence of laboratory abnormalities, which in the judgment of the investigator places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study including (but not limited to):
- Severe heart failure or evidence of acute myocardial infarction defined of having at least two of the following three features: (1) Chest pain suggestive of cardiac ischemia; (2)Electrocardiogram (ECG) findings of ST elevation of greater than 0.2 mV in 2 contiguous leads, new onset left bundle branch block, ST segment depression, or T-wave inversion; (3) Elevated troponin I. History of prior myocardial infarction within the previous 6 months.
- Evidence of prior cerebral hemorrhage or ischemic stroke within the last 3 months or recent intracerebral hematomas by head CT or MRI. This exclusion does not include clinically insignificant petechial hemorrhages.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Placenta-Derived Cells PDA001- (cenplacel-L)240 mL of intravenous infusion | Biological | Cohort 1, Cohort 2A - Experimental, Cohort 2B - Experimental |
| PlaceboThawed placebo | Drug | Cohort 2A - Experimental, Cohort 2B - Experimental |
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 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.
3 secondary outcomes
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
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
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
Results and safety
The study was stopped early (reason given: Study terminated by sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica E Luchi, MD study director
Celularity Incorporated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Human Placenta-Derived Cells PDA001- (cenplacel-L) in people with Stroke, Acute and Middle Cerebral Artery Stroke, run by Celularity Incorporated at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study terminated by sponsor). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (Type, frequency, severity and potential relationship to study drug of adverse events) (time frame: Up to 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.