Clinical Trials
“Proof of concept” has been demonstrated both “in-vitro” (laboratory studies) and “in-vivo” (treating live animals).
Companion dogs bearing malignant tumors were treated with multiple rounds of plasma filtration through the UNLEASH® adsorption column device.
First human clinical trials in the United States will follow granting of an Investigational Device Exemption by the FDA. At least one canine trial round, for safety and efficacy, will precede the IDE application.
No human trials are scheduled at this time.