Safety and Efficacy of FURESTEM-AD Inj. in Patients With Moderately Subacute and Chronic Atopic Dermatitis (AD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Kang Stem Biotech Co., Ltd.
Sponsor:
Collaborator:
Catholic Medical Center
Information provided by (Responsible Party):
Kang Stem Biotech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01927705
First received: August 20, 2013
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

The purpose of phase I clinical trial is to evaluate safety and efficacy in subjects with over Moderately subacute and chronic Atopic Dermatitis after inject. Also, The purpose of phase IIa clinical trial is to determine clinically proper dose capacity of FURESTEM-AD Inj. by evaluating safety and efficacy based on SCORAD INDEX in subjects with over Moderately subacute and chronic Atopic Dermatitis.


Condition Intervention Phase
Atopic Dermatitis
Biological: FURESTEM-AD Inj.
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase I/IIa Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-AD Inj. in Patients With Moderately Subacute and Chronic Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Kang Stem Biotech Co., Ltd.:

Primary Outcome Measures:
  • over 50% reduction ratio of SCORAD INDEX as contrasted with baseline value [ Time Frame: 4 weeks follow-up after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SCORAD Total Score [ Time Frame: 4 weeks follow-up after treatment ] [ Designated as safety issue: No ]
  • the degrees of disease [ Time Frame: 4 weeks follow-up after treatment ] [ Designated as safety issue: No ]
  • Valuation of IGA [ Time Frame: 4 weeks follow-up after treatment ] [ Designated as safety issue: No ]
  • each index of SCORAD INDEX [ Time Frame: 4 weeks follow-up after treatment ] [ Designated as safety issue: Yes ]
    TBSA, erythema, edema/papulation, oozing, excoriations, dryness, lichenification, pruritus, insomnia.

  • serum Total IgE [ Time Frame: 4 weeks follow-up after treatment ] [ Designated as safety issue: No ]
  • Valuation of EASI [ Time Frame: 4 weeks follow-up after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment

FURESTEM-AD Inj. 1. 2.5 x 10^7 stem cells after registration.

FURESTEM-AD Inj. 2. 5.0 x 10^7 stem cells after registration.

Biological: FURESTEM-AD Inj.

Detailed Description:

Atopic dermatitis is recurring and chronic Allergic eczema which accompanies serious itching and xeroderma. Atopic dermatitis has special features such as increase of acidophil, high expression ratio of IgE in the blood. Recently, Atopic dermatitis is estimated to developing for 10 to 20 percent of the population in the world. However, there is no distinguished treatment to completely recover. Especially, most of diagnosis are made when the patients are younger than 5 years old. Moreover, 50 percent of them get diagnose Atopic dermatitis between 6 month and 24 month. According to the National epidemiological investigation conducted by the Korean Academy of Pediatric Allergy and Respiratory Disease, Outbreak ratio of Atopic dermatitis continually increase for the past decade. Accordingly, it has become a major social concern. It is really important for the patients to care and diagnose as soon as they find out symptoms of Atopic dermatitis. The reason is that 50 to 75 percent of the Atopic dermatitis patients are suffering from Allergies which cause asthma and rhinitis. Recently, It has been reported that Mesenchymal stem cells have special abilities to restrict the growth of lymphocyte non-specific and to restrict the activation of lymphocyte by the stimulus of mitogen or antigen. It is also reported that the restrict of lymphocyte by Mesenchymal stem cells does not need HLA-matching unlike the case of T-cell. It has been found that Mesenchymal stem cells' ability of autoimmune induction is weak because of low expression of antigen like HLA-DR. It is also discovered that Mesenchymal stem cells do not cause autoimmune side-effect even though we inject them in the body. When the body get infected by the pathogens, innate immune response operate as the primary defence mechanism. at this time, there are some receptors reacting first such as TLR(toll-like receptor) and NLR(nucleotide-binding oligomerization domain) which is located in the cytoplasm of a cell. It is reported that the activities of TLR which is expressed by Mesenchymal stem cells play an important roles about immunomodulatory ability of Mesenchymal stem cells. Furthermore, human Umbilical Cord Blood derived-Universal Stem Cells( hUCB-USCs) manifest TLR and NLR of Mesenchymal Stem cells at the same time. when those receptors become activation, it maximize ability of immunomodulatory. Therefore, hUCB-USCs can be utilized to cure intractable autoimmune disease like Atopic dermatitis. Further, It has huge possibility as cell therapy products for autoimmune disease.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Of either gender, aged ≥20 and ≤60 years
  • Atopic Dermatitis subjects who are coincident with Hanifin and Rajka diagnosis criteria
  • subacute and chronic Atopic subjects who have Atopic Dermatitis symptoms continually at least 6 months
  • Subjects with over moderate atopic dermatitis( SCORAD score > 20 )
  • Subjects who understand and voluntarily sign an informed consent form

Exclusion Criteria:

  • Subjects who have systemic infection at the baseline visit
  • Subjects who have asthma at the baseline visit
  • Treatment with oral corticosteroids, oral antibiotics, whole body photochemotherapy, immunosuppressive drug within 4 weeks before the baseline visit
  • Treatment with topical steroids, antibiotics within 2 weeks before the baseline visit
  • Subjects who already took or need to take the medicine which is prohibited to take during the clinical study.
  • Pregnant, breast-feeding women or women who plan to become pregnant during this study. (Females of Childbearing Potential must have a negative urine pregnancy test at Screening and Baseline)
  • Subjects who currently participate in other clinical trial or participated in other clinical trial within 30 days
  • Creatinine value ≥ 2 Upper limit of the normal range at screening test
  • AST/ALT value ≥ 2 Upper limit of the normal range at screening test
  • Any other condition which the investigator judges would make patient unsuitable for study participation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01927705

Contacts
Contact: Hyunjung Kim kimhj@kangstem.com

Locations
Korea, Republic of
Catholic Medical Center Recruiting
Seoul, Korea, Republic of, 137-701
Contact: Sun-mi kim       biml@naver.com   
Contact: Yeon-ju Ahn       duswn0113@naver.com   
Principal Investigator: taeyoon kim, doctor         
Sponsors and Collaborators
Kang Stem Biotech Co., Ltd.
Catholic Medical Center
Investigators
Principal Investigator: Taeyoon Kim Catholic Medical Center
  More Information

No publications provided

Responsible Party: Kang Stem Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT01927705     History of Changes
Other Study ID Numbers: KSB-AD
Study First Received: August 20, 2013
Last Updated: August 19, 2014
Health Authority: Republic of Korea: Ministry of Food and Drug Safety

Keywords provided by Kang Stem Biotech Co., Ltd.:
Atopic dermatitis
Stem cell
Cell therapy
skin disease
furestem
AD

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 21, 2014