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

Condition(s) targeted: Stroke

Intervention: 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 Placebo (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Stem Cell Therapeutics Corp.

Official(s) and/or principal investigator(s):
Steven C Cramer, MD, Principal Investigator, Affiliation: Department of Neurology, University of California, Irvine Medical Center
Michael D Hill, MD, Principal Investigator, Affiliation: Department of Clinical Neurosciences, University of Calgary

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.

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

Secondary outcome:

NIHSS Response >=4 at Day 90

NIHSS Change From Baseline at Day 30

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

Barthel Index at Day 90

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

Gait Velocity Test Change From Baseline at Day 90

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

Line Cancellation Test Change From Baseline at Day 90

Trails A Test Change From Baseline at Day 90

Trails B Test Change From Baseline at Day 90

Geriatric Depression Scale at Day 90

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

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

Foothills Medical Center , University of Calgary, Calgary, Alberta T2N 2T9, Canada

Lalitha Super Specialty Hospitals Pvt.Ltd, Guntur, Andhra Pradesh 522001, India

Apollo Hospitals, Hyderabad, Andhra Pradesh 500023, India

Care Hospital, Hyderabad, Andhra Pradesh 500001, India

Kamineni Hospital, Hyderabad, Andhra Pradesh 500068, India

Krishna Institute of Medical Sciences, Hyderabad, Andhra Pradesh 500003, India

Mediciti Hospital, Hyderabad, Andhra Pradesh 500063, India

Owaisi Hospital and Research Centre, Hyderabad, Andhra Pradesh 500059, India

St.Theresa's General Hospital, Hyderabad, Andhra Pradesh 500018, India

DBR & SK Super Speciality Hospital, Tirupati, Andhra Pradesh 517501, India

Latha Superspecialities Hospital, Vijayawada, Andhra Pradesh 520002, India

Suraksha Neuro Centre, Vijayawada, Andhra Pradesh 520002, India

University of California, Irvine Medical Center, Orange, California 92868, United States

Max Super Speciality Hospital, New Delhi, Delhi 110017, India

J.S.S Medical College & Hospital, Bangalore, Karnataka 570004, India

M S Ramaiah Memorial Hospital, Bangalore, Karnataka 560054, India

Ananthapuri Hospitals and Research Institute, Thiruvananthapuram, Kerala 695024, India

Queen Elizabeth II Health Sciences Center, Halifax, Nova Scotia B3H 3A7, Canada

Sunnybrook Health Sciences Centre, Toronto, Ontario M4N 3M5, Canada

Christian Medical College and Hospital, Ludhiana, Punjab 141008, India

Montreal Neurological Institute, Montreal, Quebec H3A 2B4, Canada

Vijaya Health Center, Chennai, Tamilnadu 600026, India

Christian Medical College Hospital, Vellore, Tamilnadu 632004, India

Starting date: August 2009
Last updated: November 24, 2011