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| Name | Class |
|---|---|
| Stem Cell Therapeutics Corp. | INDUSTRY |
| Hoag Memorial Hospital Presbyterian | OTHER |
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The purpose of this study is to assess the safety of Beta-hCG + Erythropoietin in patients with acute ischemic stroke.
Patients with a new stroke will be evaluated at the University of California Irvine Medical Center (UCIMC), a JCAHO-certified Stroke Center, and at Hoag Memorial Hospital Presbyterian. Standard stroke pathways will be used to identify such patients and to initiate standard of care therapy. Patients potentially eligible for study enrollment will be identified, screened, then consented and enrolled. Those meeting all entry criteria, and no exclusion criteria, will undergo additional baseline testing including brain MRI. A 9-day course of B-E therapy will then begin, always within 48 hours after stroke onset. This therapy will consist of hCG (3 once-daily IM doses at 10,000 IU per dose, one day apart, on days 1, 3 and 5 of study participation), followed by a one day washout period (day 6), followed by Epo (three once-daily i.v. doses at 30,000 IU per dose on days 7, 8, and 9 of study participation). Patients will be examined at several time points during therapy, as well as 6 weeks and 3 months after stroke onset. The primary outcome measures are related to safety, while secondary outcome measures are related to disability, neurological status, and MRI measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual Growth Factor | Experimental | All patients received erythropoietin and beta-hCG. This was the only treatment arm in the study, i.e., all enrollees received active therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual Growth Factor | Drug | 10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation 30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Safety through Day 90 was assessed through adverse event reporting, serial examinations, blood testing, and a leg vein Doppler at Day 42. Number of participants who experienced adverse events, had abnormality in serial examinations, blood testing, and a leg vein Doppler at Day 42. | 3 mo |
| Morbidity | attributable to experimental intervention | 3 mo |
| Mortality | attributable to experimental intervention | 3 mo |
| Measure | Description | Time Frame |
|---|---|---|
| Action Research Arm Test | The Action Research Arm Test is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty 1: Performs test partially 0: Can perform no part of test. Total scores range from 0-57 points, a higher score being better with 57 being considered "normal". |
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Inclusion Criteria:
Exclusion Criteria:
Pre-existing and active major psychiatric or other neurological disease
History of significant alcohol or drug abuse in the prior 3 years
Serum hemoglobin > 16 g/dL in a male patient or > 14 g/dL in a female patient; or a platelet count > 400,000/mm3 in either a male or female patient
Advanced liver, kidney, cardiac, or pulmonary disease; the former will be operationally defined as a serum bilirubin > 4 mg/dL, alkaline phosphatase > 250 U/L, SGOT > 150 U/L, SGPT >150 U/L, or creatinine > 3.5 mg/dL
Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years, using a test that reliably detects beta-hCG levels > 25 with normal levels being < 8 IU/L.
Contraindication to study participation on the basis of any of the following:
Current use of either beta-hCG or Erythropoietin
Other condition known to elevate beta-hCG, active in the prior 24 months, e.g., choriocarcinoma or germ cell tumor
Terminal medical diagnosis consistent with survival < 1 year
Known hypercoagulable state, which for the purposes of this study will deficiency of proteins C, S, or antithrombin III; activated protein C resistance; prothrombin gene mutation; or an anti-phospholipid antibody syndrome as based on clinical and laboratory measures.
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| Name | Affiliation | Role |
|---|---|---|
| Steven C. Cramer, MD, MMSc | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine Medical Center | Orange | California | 92868-4280 | United States |
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Subjects were consented and enrolled from September 2006 to February 2008 in accordance with local Institutional Review Boards at 3 North American sites: University of California Irvine Medical Center (n=11), Hoag Memorial Hospital Presbyterian (n=1), and the Foothills Hospital at University of Calgary (n=3).
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| ID | Title | Description |
|---|---|---|
| FG000 | Beta-hCG + Erythropoietin | Subjects received a 9-day course of beta-human chorionic gonadotropin (once daily on Days 1, 3, and 5 of study participation) followed by erythropoietin (once daily on Days 7, 8, and 9 of study participation) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Beta-hCG + Erythropoietin | Subjects received a 9-day course of beta-human chorionic gonadotropin (once daily on Days 1, 3, and 5 of study participation) followed by erythropoietin (once daily on Days 7, 8, and 9 of study participation) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety | Safety through Day 90 was assessed through adverse event reporting, serial examinations, blood testing, and a leg vein Doppler at Day 42. Number of participants who experienced adverse events, had abnormality in serial examinations, blood testing, and a leg vein Doppler at Day 42. | Posted | Number | participants | 3 mo |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Beta-hCG + Erythropoietin | Subjects received a 9-day course of beta-human chorionic gonadotropin (once daily on Days 1, 3, and 5 of study participation) followed by erythropoietin (once daily on Days 7, 8, and 9 of study participation) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven Cramer | University of California Irvine | (714) 456-6876 | scramer@uci.edu |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 3 mo |
| Fugl-Meyer Arm Scale | Fugl-Meyer arm scale is a measurement scale of the upper body with three sections being Proximal, Wrist/Hand, and Coordination/Speed. The scores can range from 0-66 with a higher score being better. A score of 66 is considered "normal" with no impairments. | 3 mo |
| Fugl-Meyer Leg Scale | Measure of leg motor impairment with three subsections which are Proximal, Hip/Knee, and Speed/Coordination. The scale ranges from 0-34 with a higher score being better. A score of 34 is considered "normal". | 3 mo. |
| Boston Naming Test | Measure of aphasia or other language disturbance caused by stroke or other dementing disorders. It consists of 60 line drawings graded in difficulty in which patients are to name each picture. | 3 mo |
| Line Cancellation Test | Measure of spatial neglect where patients must cross out lines placed in a random orientation. Missed lines may indicate areas of spatial neglect. | 3 mo |
| NIH Stroke Scale | Measure of global impairment post stroke. It includes 11 items to examine levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The scoring scale is between 0-42 where a higher score is indicative of a more severe stroke. | 3 mo |
| Geriatric Depression Scale Short Form | Measure of depression done as a self-report. It is a series of 15 questions designed to be a screen for depression. The scores range from 0-15 with a higher score being more indicative of depression. | 3 mo |
| Barthel Index | Measure of disability in terms of performance of activities of daily living (ADL). The scores range from 0-100 with a higher score being associated with a higher level of independence. | 3 mo |
| Infarct Volume Using Anatomical MRI | Measurement of infarct volume and percent change from baseline to Day 90. | 3 mo |
| Trail Making A Test | Measure of memory and executive function where one is asked to connect dots consecutively based on the number of the dot. Test taker is allowed 2 minutes to connect the dots with a maximum score of 25 for all dots connected correctly. | 3 mo |
| Trail Making B Test | Measure of memory and executive function where one is asked to connect dots with letters and numbers alternating between number and letter and connecting dots consecutively. Test taker is allowed 4 minutes to connect the dots with a maximum score of 25 for all dots connected correctly. | 3 mo. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| History of Hypertension | Number | participants |
|
| History of Hyperlipidemia | Number | participants |
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| History of Diabetes Mellitus | Number | participants |
|
| History of Prior Stroke | Number | participants |
|
| History of Atrial Fibrillation | Number | participants |
|
| Participants |
|
|
| Primary | Morbidity | attributable to experimental intervention | Posted | Number | participants | 3 mo |
|
|
|
| Primary | Mortality | attributable to experimental intervention | Posted | Number | participants | 3 mo |
|
|
|
| Secondary | Action Research Arm Test | The Action Research Arm Test is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty 1: Performs test partially 0: Can perform no part of test. Total scores range from 0-57 points, a higher score being better with 57 being considered "normal". | This number (9) is the total # subjects who could complete the test at all study time points; some subjects were unable to complete this test at one of the time points, especially the acute stroke assessment. | Posted | Median | Full Range | Units on a scale | 3 mo |
|
|
|
| Secondary | Fugl-Meyer Arm Scale | Fugl-Meyer arm scale is a measurement scale of the upper body with three sections being Proximal, Wrist/Hand, and Coordination/Speed. The scores can range from 0-66 with a higher score being better. A score of 66 is considered "normal" with no impairments. | Posted | Median | Full Range | Units on a scale | 3 mo |
|
|
|
| Secondary | Fugl-Meyer Leg Scale | Measure of leg motor impairment with three subsections which are Proximal, Hip/Knee, and Speed/Coordination. The scale ranges from 0-34 with a higher score being better. A score of 34 is considered "normal". | Posted | Median | Full Range | Units on a scale | 3 mo. |
|
|
|
| Secondary | Boston Naming Test | Measure of aphasia or other language disturbance caused by stroke or other dementing disorders. It consists of 60 line drawings graded in difficulty in which patients are to name each picture. | Posted | Median | Full Range | Units on a scale | 3 mo |
|
|
|
| Secondary | Line Cancellation Test | Measure of spatial neglect where patients must cross out lines placed in a random orientation. Missed lines may indicate areas of spatial neglect. | Posted | Median | Full Range | ratio of canceled lines on each side | 3 mo |
|
|
|
| Secondary | NIH Stroke Scale | Measure of global impairment post stroke. It includes 11 items to examine levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The scoring scale is between 0-42 where a higher score is indicative of a more severe stroke. | Posted | Median | Full Range | Units on a scale | 3 mo |
|
|
|
| Secondary | Geriatric Depression Scale Short Form | Measure of depression done as a self-report. It is a series of 15 questions designed to be a screen for depression. The scores range from 0-15 with a higher score being more indicative of depression. | Posted | Median | Full Range | Units on a scale | 3 mo |
|
|
|
| Secondary | Barthel Index | Measure of disability in terms of performance of activities of daily living (ADL). The scores range from 0-100 with a higher score being associated with a higher level of independence. | Posted | Median | Full Range | Units on a scale | 3 mo |
|
|
|
| Secondary | Infarct Volume Using Anatomical MRI | Measurement of infarct volume and percent change from baseline to Day 90. | Posted | Mean | Standard Error | percent change | 3 mo |
|
|
|
| Secondary | Trail Making A Test | Measure of memory and executive function where one is asked to connect dots consecutively based on the number of the dot. Test taker is allowed 2 minutes to connect the dots with a maximum score of 25 for all dots connected correctly. | Posted | Median | Full Range | correct connections | 3 mo |
|
|
|
| Secondary | Trail Making B Test | Measure of memory and executive function where one is asked to connect dots with letters and numbers alternating between number and letter and connecting dots consecutively. Test taker is allowed 4 minutes to connect the dots with a maximum score of 25 for all dots connected correctly. | Posted | Median | Full Range | correct connections | 3 mo. |
|
|
|
| 6 |
| 15 |
| 0 |
| 15 |
| Deep Vein Thrombosis | Vascular disorders | Systematic Assessment |
|
| Cerebral embolism | Nervous system disorders | Systematic Assessment |
|
| Mediastinal sepsis | Infections and infestations | Systematic Assessment |
|
| Retroperitoneal hemorrhage | General disorders | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |