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REGENESIS (CA): A Study of NTxâ„¢-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients

Summary

Primary objective: To assess the neurological outcome in acute ischemic stroke patients
treated with NTxâ„¢-265, when compared with patients given a placebo control.

Secondary objective: To assess the safety and tolerability of NTxâ„¢-265 when given to acute
ischemic stroke patients.

Study Design

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

Conditions

Stroke

Intervention

NTxâ„¢-265: rhCG, then rEPO, Saline placebo

Location

Department of Clinical Neurosciences, Univeristy of Calgary
Calgary
Alberta
Canada
T2N 2T9

Status

Terminated

Source

Stem Cell Therapeutics Corp.

Results (where available)

View Results

Links

MESH Definitions

Haloarcula

A genus of HALOBACTERIACEAE distinguished from other genera in the family by the presence of specific derivatives of TGD-2 polar lipids. Haloarcula are found in neutral saline environments such as salt lakes, marine salterns, and saline soils.

Halomonadaceae

A family of gram-negative, moderately halophilic bacteria in the order Oceanospirillales. Members of the family have been isolated from temperate and Antarctic saline lakes, solar salt facilities, saline soils, and marine environments.

Stroke

A group of pathological conditions characterized by sudden, non-convulsive loss of neurological function due to BRAIN ISCHEMIA or INTRACRANIAL HEMORRHAGES. Stroke is classified by the type of tissue NECROSIS, such as the anatomic location, vasculature involved, etiology, age of the affected individual, and hemorrhagic vs. non-hemorrhagic nature. (From Adams et al., Principles of Neurology, 6th ed, pp777-810)

Therapeutic Misconception

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

Heat Stroke

A condition caused by the failure of body to dissipate heat in an excessively hot environment or during PHYSICAL EXERTION in a hot environment. Contrast to HEAT EXHAUSTION, the body temperature in heat stroke patient is dangerously high with red, hot skin accompanied by DELUSIONS; CONVULSIONS; or COMA. It can be a life-threatening emergency and is most common in infants and the elderly.

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