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

Stem Cell Therapeutics

Status and phase

Terminated

Phase 2

Conditions

Stroke

Treatments

Drug: Saline Placebo

Drug: human chorionic gonadotropin (hCG), then epoetin alfa (EPO)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00938314

NTx®-265-CP-202-IS

Details and patient eligibility

About

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.

Enrollment

96 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

96 participants in 4 patient groups, including a placebo group

NTx®-265 Low Dose

Experimental group

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

Treatment:

Drug: human chorionic gonadotropin (hCG), then epoetin alfa (EPO)

NTx®-265 Medium Dose

Experimental group

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

Treatment:

Drug: human chorionic gonadotropin (hCG), then epoetin alfa (EPO)

NTx®-265 High Dose

Experimental group

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