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

S

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)
Drug: human chorionic gonadotropin (hCG), then epoetin alfa (EPO)
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)
Drug: human chorionic gonadotropin (hCG), then epoetin alfa (EPO)
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
Treatment:
Drug: 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)
Saline Placebo
Placebo Comparator group
Treatment:
Drug: Saline Placebo

Trial contacts and locations

23

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Data sourced from clinicaltrials.gov

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