?/?a clinical research to evaluate the safety and effectiveness of EBI-H (Auto-derived activated lymphocyte) for subacute above medium severity and chronic atopic dermatitis patients

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0003056

Enrollment

Registered

2018-08-01

Start date

2017-08-16

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug, Biological/Vaccine, Non-Stem Cell : In this clinical test, EBI-H is treated as a test drug with the cells of 2 times 10 to the 8 as the first test group and the cells of 2 times 10 to the 9 as

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) A person under the age of 65 and above the age of 19 years old 2) The proper atopic dermatitis patients according to Hanifin and Rajka diagnostic criteria 3) The subacute and chronic atopic dermatitis patients with atopic dermatitis symptoms that have lasted for more than 6 months at least 4) The subacute above medium severity atopic dermatitis patients (EASI score over 7 points) 5) The specific patients who have not been improved through the general treatment or can not use the pre-developed medicine because of concern about potential side-effect 6) A fertile woman who is negative in the pregnancy test and agrees to use the permitted manner of contraception during clinical research 7) A patient who has voluntarily agreed to participate in this clinical research with written consent

Exclusion criteria

Exclusion criteria: 1) A patient who have other uncontrolled diseases including infection above medium severity and bleeding 2) A person who has positive in HBV, HCV, HIV and VDRL 3) A patient whose blood pressure cannot be controlled under SBP 140mmHg or DBP 90mmHg with injecting antihypertensive drug, during screening 4) An uncontrolled patient with diabetes whose HbA1c values is over 8.0 during screening 5) An asthmatic patient who needs high concentration of inhaled steroids with 2nd modifier or systemic steroid therapy or uncontrolled patient with those treatment 6) A patient who has skin autoimmune disease including psoriasis and systemic autoimmune diseases (Erythema lupus, rheumatism arthritis, severe muscle failure, etc) 7) A person who uses systemic adrenocortical hormone drug, systemic immune suppressor/immune modulator, high potency topical adrenocortical hormone drug (WHO Group I~III), topical immune modulator and biological drug within 4 weeks before screening 8) A patient who took topical adrenocortical hormone drug (WHO Group IV, V), systemic photochemotherapy and systemic antibiotic within 2 weeks before screening 9) A patient who took antihistamine through oral or injection methods within a week before participating in the clinical research 10) A patient who have taken a prohibited combinatory drug or have to take a prohibited combinatory drug during clinical research 11) A pregnant woman or lactating woman 12) A fertile woman who don’t want to follow a proper method of contraception during clinical research 13) A patient who has been participating in or had already participated in another clinical research within 30 days 14) A patient who is judged as improper for this research by researchers

Design outcomes

Primary

Measure	Time frame
EASI score	—

Secondary

Measure	Time frame
SCORAD score;IGA score;Plasm total IgE;DLQI score	—

Countries

Korea, Republic of

Contacts

Public ContactBeomjoon Kim

Chung-Ang Univerisity Hospital

Outcome results