Safety and Efficacy of FURESTEM-AD Inj. in Patients With Moderately Subacute and Chronic Atopic Dermatitis (AD)
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      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.
    

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.
    

Intervention name(s): FURESTEM-AD Inj.
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atopic dermatitis; Stem cell; Cell therapy; skin disease; furestem; AD; hUCB-MSC; UCB-MSC; Umbilical cord Blood