Safety and Efficacy of FURESTEM-AD Inj. in Patients With Moderately Subacute and Chronic Atopic Dermatitis (AD)
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.
|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|
- 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 ]
- 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 ]
|Study Start Date:||September 2013|
|Study Completion Date:||August 2015|
|Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
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.|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01927705
|Korea, Republic of|
|Catholic Medical Center|
|Seoul, Korea, Republic of, 137-701|
|Principal Investigator:||Taeyoon Kim||Catholic Medical Center|