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Trial · Interventional

TerminatedPhase 2Results postedRegistry data

Study of NTx®-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients

Short name REGENESIS-LED

NCTNCT00938314 (opens ClinicalTrials.gov in a new tab)Other idNTx®-265-CP-202-IS
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 2
Enrollment
96 participants (actual)
Sponsor
Stem Cell Therapeutics Corp. · Industry
Design
Randomized · Double masking
Countries
3 countries

United States, Canada, India

Start
Aug 2009
Primary completion
Apr 2010
Completion
Apr 2010
First posted
13 Jul 2009 (estimated)
Last update posted
29 Nov 2011 (estimated)
Conditions
Stroke

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200920102011
  1. Ph 2

    REGENESIS-LED

    NCT00938314

    Aug 2009 to Apr 2010

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is: * To assess the neurological outcome in acute ischemic stroke patients treated with NTx®-265, when compared with patients given a placebo control. * To assess the safety and tolerability of NTx®-265 when given to acute ischemic stroke patients.

Interventions

  • human chorionic gonadotropin (hCG), then epoetin alfa (EPO)Drug
  • human chorionic gonadotropin (hCG), then epoetin alfa (EPO)Drug
  • human chorionic gonadotropin (hCG), then epoetin alfa (EPO)Drug
  • Saline PlaceboDrug

Arms4

  • Experimental

    NTx®-265 Low Dose

    hCG 385 µg (10,000 international unit \[IU\]), subcutaneously (SC), on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, intravenously (IV), on Day 7, 8, and 9 of study participation

  • Experimental

    NTx®-265 Medium Dose

    hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation

  • Experimental

    NTx®-265 High Dose

    hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation

  • Placebo comparator

    Saline Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. National Institutes of Health Stroke Scale (NIHSS) Change From Baseline at Day 90

    Time frame · Baseline and Day 90

    Registry description

    The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead).

Secondary outcomes(11)

  1. NIHSS Response >=4 at Day 90

    Time frame · Baseline and Day 90

    Registry description

    The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead). NIHSS Response \>=4 is defined as a \>=4 change from baseline at Day 90.

  2. NIHSS Change From Baseline at Day 30

    Time frame · Baseline and Day 30

    Registry description

    The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead).

  3. Modified Rankin Scale (mRS) Response <=2 at Day 90

    Time frame · Day 90

    Registry description

    The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0 (perfect health without symptoms) to 6 (dead). mRS response \<=2 is defined as the mRS score \<=2 at Day 90.

  4. Barthel Index at Day 90

    Time frame · Day 90

    Registry description

    The Barthel Index measures 10 activities of daily living and mobility. A score of 100 = is best (able to live at home with a degree of independence), 0 is worst.

  5. Action Research Arm Test (ARAT) Change From Baseline at Day 90

    Time frame · Baseline and Day 90

    Registry description

    The ARAT assesses recovery of arm function following stroke through a series of subtests judging ability to grasp, grip, pinch, or move the arm; scores are on a scale; The total maximum (best) score is 57 and the total minimum (worst) score is 0.

  6. Gait Velocity Test Change From Baseline at Day 90

    Time frame · Baseline and Day 90

    Registry description

    The Gait Velocity Test assesses ability to walk as measured by the time (seconds) it takes a patient to walk 10 meters.

  7. Boston Naming Test (BNT) Change From Baseline at Day 90

    Time frame · Baseline and Day 90

    Registry description

    The BNT assesses impairment of language ability by asking patients to identify 20 different pictures each time the test is taken. A score of 20 is best, 0 is worst.

  8. Line Cancellation Test Change From Baseline at Day 90

    Time frame · Baseline and Day 90

    Registry description

    The Line Cancellation Test detects the loss of awareness of one side of the body. A score of 0.00 (no units) is normal (patient favors neither right nor left side). A score of +1.00 indicates severe unawareness of the left side. A score of -1.00 indicates severe unawareness of the right side.

  9. Trails A Test Change From Baseline at Day 90

    Time frame · Baseline and Day 90

    Registry description

    The Trails A test measures visual scanning, numeric sequencing, and visual-motor coordination; the test score is the time (seconds) required to connect 25 numbers (e.g., 1, 2, 3, 4…)

  10. Trails B Test Change From Baseline at Day 90

    Time frame · Baseline and Day 90

    Registry description

    The Trails B test measures visual scanning, numeric sequencing, and visual-motor coordination; the test score is the time (seconds) required to connect 25 alpha numeric circles (e.g., 1, A, 2, B, 3, C, 4, D)

  11. Geriatric Depression Scale at Day 90

    Time frame · Day 90

    Registry description

    The Geriatric Depression Scale is commonly used to assess depression in stroke patients of any age by asking 15 yes/no questions, and then scored. A score of 0 - 5 is normal, whereas a score of 6 -15 suggests depression.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline and Day 90

National Institutes of Health Stroke Scale (NIHSS) Change From Baseline at Day 90

GroupValue (scores on a scale)Spread
NTx®-265 Low Dose6.794.22
NTx®-265 Medium Dose6.504.53
NTx®-265 High Dose6.083.30
Saline Placebo7.174.24
Secondary and other outcome results(7)
Secondary outcomeNumber· Baseline and Day 90

NIHSS Response >=4 at Day 90

GroupValue (participants)
NTx®-265 Low Dose6
NTx®-265 Medium Dose7
NTx®-265 High Dose5
Saline Placebo5
Secondary outcomeMean· Baseline and Day 30

NIHSS Change From Baseline at Day 30

GroupValue (scores on a scale)Spread
NTx®-265 Low Dose4.674.53
NTx®-265 Medium Dose4.293.37
NTx®-265 High Dose5.002.98
Saline Placebo5.333.33
Secondary outcomeNumber· Day 90

Modified Rankin Scale (mRS) Response <=2 at Day 90

GroupValue (participants)
NTx®-265 Low Dose11
NTx®-265 Medium Dose11
NTx®-265 High Dose15
Saline Placebo18
Secondary outcomeMean· Day 90

Barthel Index at Day 90

GroupValue (Scores on a scale)Spread
NTx®-265 Low Dose68.1829.62
NTx®-265 Medium Dose80.1722.04
NTx®-265 High Dose85.2520.28
Saline Placebo90.8912.69
Secondary outcomeMean· Baseline and Day 90

Action Research Arm Test (ARAT) Change From Baseline at Day 90

GroupValue (scores on a scale)Spread
NTx®-265 Low Dose10.6713.37
NTx®-265 Medium Dose33.5026.12
NTx®-265 High Dose30.3316.80
Saline Placebo23.7520.27
Secondary outcomeMean· Baseline and Day 90

Gait Velocity Test Change From Baseline at Day 90

GroupValue (seconds)Spread
NTx®-265 Low Dose-22.7541.60
NTx®-265 Medium Dose-50.3348.95
NTx®-265 High Dose-6.407.37
Saline Placebo-53.8054.15
Secondary outcomeMean· Baseline and Day 90

Boston Naming Test (BNT) Change From Baseline at Day 90

GroupValue (Scores on a scale)Spread
NTx®-265 Low Dose3.933.10
NTx®-265 Medium Dose4.174.11
NTx®-265 High Dose0.202.74
Saline Placebo3.693.82

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
NTx®-265 Low DosehCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation–2 / 249 / 24
NTx®-265 Medium DosehCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation–4 / 2419 / 24
NTx®-265 High DosehCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation–3 / 242 / 24
Saline Placebosaline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation–2 / 2410 / 24

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedCramer SC, Hill MD; REGENESIS-LED Investigators. Human choriogonadotropin and epoetin alfa in acute ischemic stroke patients (REGENESIS-LED trial). Int J Stroke. 2014 Apr;9(3):321-7. doi: 10.1111/ijs.12260. Epub 2014 Mar 3. PMID 24588854

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Age 18-85 * NIHSS score 8-20 * Stroke is ischemic in origin, supratentorial, and radiologically confirmed * Patient is 24-48 hours from time of stroke onset when the first dose of NTx®-265 therapy is administered * Reasonable expectation of availability to receive the full 9 day NTx®- 265 therapy and subsequent follow-up visits * Reasonable expectation that patient will receive standard post-stroke physical, occupational, speech, and cognitive therapy as indicated * Female patient is either not of childbearing potential or agrees to use two of the effective separate non-hormonal forms of contraception throughout the study Exclusion Criteria: * Patients presenting with lacunar, hemorrhagic and/or brain stem stroke * Patients who have received tissue plasminogen activator (tPA)following the index stroke * Patients classified as comatose * Women who have tested positive for pregnancy, or are breast-feeding, or are not using a birth control * Serum hemoglobin \> 16 grams(g)/deciliter (dL)(males) or \> 14 g/dL (females); or platelet count \> 400,000/cubic millimeters(mm3) * Advanced liver, kidney, cardiac, or pulmonary disease * Elevated serum bilirubin,alkaline phosphatase, aspartate aminotransferase (AST) or alanine transaminase (ALT),creatinine, or prostate-specific antigen (PSA) levels * Patients with a known history of hypercoagulability * Expected survival \< 1 year * Allergy or other contraindication to hCG or EPO * A known diagnosis of cancer in the previous 5 years * Uncontrolled hypertension * Use of either hCG or epoetin alfa within the previous 90 days * Any condition known to elevate hCG * Patients with a pre-stroke/pre-morbid modified Rankin Score (mRS)≥ 2 * Any patients not living independently * Any other medical condition or degree of stroke such that, in the investigator's opinion, the patient should not be included in the trial * With the exception of the qualifying stroke, any other stroke within the previous 3 months * Patients who cannot take anti-platelet or anti-coagulant therapy * Pre-existing and active major psychiatric or other chronic neurological disease * Alcohol abuse or have a history of substance abuse or dependency within 12 months prior to the study * Currently participating in another investigational study

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