Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Subjects will be considered eligible for participation in the study if all the following inclusion criteria are satisfied:

Informed consent obtained before any "trial-related activities" (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
Diagnosis of plaque psoriasis for at least 6 months with at least one psoriatic plaque measuring between 2 cm and 5 cm at the time of screening

If female, subject is either not of childbearing potential (postmenopausal for at least 1 year or surgically sterile) or is of childbearing potential and is using approved method of birth control throughout study and for 1 month after last dose of study drug. Approved methods of birth control include the following:

Condoms, sponge, foams, jellies, diaphragm, or intrauterine device (IUD)
Hormonal contraceptives for 90 days prior to study drug administration
A vasectomized partner

Subject must be able and willing to provide written informed consent and comply with requirements of this study protocol

Following Eligibility & Consent:

Subject must be able to donate 130 ml to 490 ml of blood for NKMax America to obtain an adequate number of autologous NK cells necessary to establish the final investigational product
Successful establishment of the final NK product, or "study therapy", established by NKMax America

Exclusion Criteria:

Subjects who fulfill any of the following criteria will not be recruited into the study:

Subjects with severe medical condition(s) that in the view of the investigator prohibits participation in the study
Subject has Netherton's syndrome or other genodermatoses that results in a defective epidermal barrier
Subjects who have applied topical medication (prescription or over-the-counter) for the treatment of psoriasis to their body within 7 days of the baseline visit
Subjects who have taken cyclosporine, methotrexate, immuran, oral retinoids, chemotherapeutic agents, anti-inflammatory biologics (e.g., alefacept, etanercept, etc.), or oral calcineurin inhibitors within 28 days of the whole blood donation visit for the establishment of the investigational product
Subjects who are unable to hold their current psoriasis medications for the period of time indicated (at least 7 days for topical medications, at least 28 days for oral or injectable medications) without significant worsening of their psoriasis
Immunocompromised subjects (e.g., lymphoma, HIV/AIDS, Wiskott-Aldrich Syndrome) or subjects with a history of malignant disease (excluding non-melanoma skin cancer) as determined by the participant's medical history
Subjects receiving phototherapy (e.g., ultraviolet light B [UVB], psoralen plus ultraviolet light A [PUVA]) within 28 days of the baseline visit.
Subjects with a history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol.
Subjects with significant concurrent medical condition(s) at screening that in the view of the investigator prohibits that in the view of the investigator prohibits participation in the study (e.g., severe concurrent allergic disease, condition associated with malignancy, and condition associated with immunosuppression)
Subjects with an active bacterial, viral or fungal skin infection (excluding nail fungus)
Ongoing participation in an investigational drug trial
Presence of psoriasis with exfoliative erythroderma or presence of guttate psoriasis, primary palmoplantar psoriasis, or pustular psoriasis