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

Primary Purpose

Stroke

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
human chorionic gonadotropin (hCG), then epoetin alfa (EPO)
human chorionic gonadotropin (hCG), then epoetin alfa (EPO)
human chorionic gonadotropin (hCG), then epoetin alfa (EPO)
Saline Placebo
Sponsored by
Stem Cell Therapeutics Corp.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, Irvine Medical Center
  • Foothills Medical Center , University of Calgary
  • Queen Elizabeth II Health Sciences Center
  • Sunnybrook Health Sciences Centre
  • Montreal Neurological Institute
  • Lalitha Super Specialty Hospitals Pvt.Ltd
  • Care Hospital
  • Krishna Institute of Medical Sciences
  • St.Theresa's General Hospital
  • Apollo Hospitals
  • Owaisi Hospital and Research Centre
  • Mediciti Hospital
  • Kamineni Hospital
  • DBR & SK Super Speciality Hospital
  • Latha Superspecialities Hospital
  • Suraksha Neuro Centre
  • Max Super Speciality Hospital
  • M S Ramaiah Memorial Hospital
  • J.S.S Medical College & Hospital
  • Ananthapuri Hospitals and Research Institute
  • Christian Medical College and Hospital
  • Vijaya Health Center
  • Christian Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

NTx®-265 Low Dose

NTx®-265 Medium Dose

NTx®-265 High Dose

Saline Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

NIHSS Response >=4 at Day 90
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.
NIHSS Change From Baseline at Day 30
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).
Modified Rankin Scale (mRS) Response <=2 at Day 90
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.
Barthel Index at Day 90
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.
Action Research Arm Test (ARAT) Change From Baseline at Day 90
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.
Gait Velocity Test Change From Baseline at Day 90
The Gait Velocity Test assesses ability to walk as measured by the time (seconds) it takes a patient to walk 10 meters.
Boston Naming Test (BNT) Change From Baseline at Day 90
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.
Line Cancellation Test Change From Baseline at Day 90
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.
Trails A Test Change From Baseline at Day 90
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…)
Trails B Test Change From Baseline at Day 90
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)
Geriatric Depression Scale at Day 90
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.

Full Information

First Posted
July 9, 2009
Last Updated
November 24, 2011
Sponsor
Stem Cell Therapeutics Corp.
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1. Study Identification

Unique Protocol Identification Number
NCT00938314
Brief Title
Study of NTx®-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients
Acronym
REGENESIS-LED
Official Title
A Phase IIb Prospective, Randomized, Double-blind, Placebo Controlled, Multicenter, Dose Escalation Study of NTx®-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients (REGENESIS-LED)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Terminated
Why Stopped
Slow Enrollment
Study Start Date
August 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stem Cell Therapeutics Corp.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NTx®-265 Low Dose
Arm Type
Experimental
Arm Description
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
Arm Title
NTx®-265 Medium Dose
Arm Type
Experimental
Arm Description
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
Arm Title
NTx®-265 High Dose
Arm Type
Experimental
Arm Description
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
Arm Title
Saline Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
human chorionic gonadotropin (hCG), then epoetin alfa (EPO)
Other Intervention Name(s)
Ovidrel, Ovitrelle, Epogen, Eprex
Intervention Description
hCG 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
Intervention Type
Drug
Intervention Name(s)
human chorionic gonadotropin (hCG), then epoetin alfa (EPO)
Other Intervention Name(s)
Ovidrel, Ovitrelle, Epogen, Eprex
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
human chorionic gonadotropin (hCG), then epoetin alfa (EPO)
Other Intervention Name(s)
Ovidrel, Ovitrelle, Epogen, Eprex
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Saline Placebo
Other Intervention Name(s)
Sodium Chloride 0.9%
Intervention Description
Saline SC, on Day 1, 3, and 5 of study participation, then Saline IV, on Day 7, 8, and 9 of study participation
Primary Outcome Measure Information:
Title
National Institutes of Health Stroke Scale (NIHSS) Change From Baseline at Day 90
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).
Time Frame
Baseline and Day 90
Secondary Outcome Measure Information:
Title
NIHSS Response >=4 at Day 90
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.
Time Frame
Baseline and Day 90
Title
NIHSS Change From Baseline at Day 30
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).
Time Frame
Baseline and Day 30
Title
Modified Rankin Scale (mRS) Response <=2 at Day 90
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.
Time Frame
Day 90
Title
Barthel Index at Day 90
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.
Time Frame
Day 90
Title
Action Research Arm Test (ARAT) Change From Baseline at Day 90
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.
Time Frame
Baseline and Day 90
Title
Gait Velocity Test Change From Baseline at Day 90
Description
The Gait Velocity Test assesses ability to walk as measured by the time (seconds) it takes a patient to walk 10 meters.
Time Frame
Baseline and Day 90
Title
Boston Naming Test (BNT) Change From Baseline at Day 90
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.
Time Frame
Baseline and Day 90
Title
Line Cancellation Test Change From Baseline at Day 90
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.
Time Frame
Baseline and Day 90
Title
Trails A Test Change From Baseline at Day 90
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…)
Time Frame
Baseline and Day 90
Title
Trails B Test Change From Baseline at Day 90
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)
Time Frame
Baseline and Day 90
Title
Geriatric Depression Scale at Day 90
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.
Time Frame
Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven C Cramer, MD
Organizational Affiliation
Department of Neurology, University of California, Irvine Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael D Hill, MD
Organizational Affiliation
Department of Clinical Neurosciences, University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Foothills Medical Center , University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Montreal Neurological Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
Lalitha Super Specialty Hospitals Pvt.Ltd
City
Guntur
State/Province
Andhra Pradesh
ZIP/Postal Code
522001
Country
India
Facility Name
Care Hospital
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500001
Country
India
Facility Name
Krishna Institute of Medical Sciences
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500003
Country
India
Facility Name
St.Theresa's General Hospital
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500018
Country
India
Facility Name
Apollo Hospitals
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500023
Country
India
Facility Name
Owaisi Hospital and Research Centre
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500059
Country
India
Facility Name
Mediciti Hospital
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500063
Country
India
Facility Name
Kamineni Hospital
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500068
Country
India
Facility Name
DBR & SK Super Speciality Hospital
City
Tirupati
State/Province
Andhra Pradesh
ZIP/Postal Code
517501
Country
India
Facility Name
Latha Superspecialities Hospital
City
Vijayawada
State/Province
Andhra Pradesh
ZIP/Postal Code
520002
Country
India
Facility Name
Suraksha Neuro Centre
City
Vijayawada
State/Province
Andhra Pradesh
ZIP/Postal Code
520002
Country
India
Facility Name
Max Super Speciality Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110017
Country
India
Facility Name
M S Ramaiah Memorial Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560054
Country
India
Facility Name
J.S.S Medical College & Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
570004
Country
India
Facility Name
Ananthapuri Hospitals and Research Institute
City
Thiruvananthapuram
State/Province
Kerala
ZIP/Postal Code
695024
Country
India
Facility Name
Christian Medical College and Hospital
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141008
Country
India
Facility Name
Vijaya Health Center
City
Chennai
State/Province
Tamilnadu
ZIP/Postal Code
600026
Country
India
Facility Name
Christian Medical College Hospital
City
Vellore
State/Province
Tamilnadu
ZIP/Postal Code
632004
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
24588854
Citation
Cramer 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.
Results Reference
derived

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

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