Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||19 Years - 65 Years|
Inclusion Criteria:1. 19-65 years old(both sexes) 2. Have been diagnosed with plaque-type psoriasis at least 6 months prior to screening (subjects with concurrent psoriatic arthritis[PsA] may be enrolled) 3. Psoriasis Area and Severity Index (PASI) score >= 12 at screening 4. BSA(Body Surface Area) >= 10 percentage at screening 5. Have had at least one of the following conventional systemic agent for the treatment of psoriasis,
- - MTX, Cyclosporine, Photochemotherapy, TNF-alpha inhibitor or IL-12/IL-23 inhibitor 6.
Exclusion Criteria:1. Subject who has other types of psoriasis (eg. Erythrodermic, guttate, or pustular) 2. Have a history of chronic or recurrent infectious disease 3. Have received phototherapy or any systemic medications/treatments within 4 weeks of screening that could affect psoriasis or PASI evaluation 4. Have used topical medications/treatments within 2 weeks of screening that could affect psoriasis or PASI evaluation 5. Have used any systemic immunosuppressants within 4 weeks of screening 6. Have been administered with the following biological agents that could affect plaque-type psoriasis
- - Etanercept - within 4 weeks of screening - Adalimumab, alefacept, infliximab - within 2 months of screening - Ustekinumab - within 4 weeks of screening - Other investigational biological agents - within 4 weeks of screening/five half-lives(whichever was longer) 7.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Kang Stem Biotech Co., Ltd.|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||Seoul St. Mary's Hospital|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Korea, Republic of|
The disease, disorder, syndrome, illness, or injury that is being studied.
This is a phase 1, single center, randomized, open label, study of safety of FURESTEM-CD Inj. in subjects with moderate to severe plaque psoriasis. Approximately 9~18 subjects will be administrated FURESTEM-CD Inj. FURESTEM-CD Inj. is composed of allogeneic hUCB-MSC(human Umbilical Cord Blood derived-Mesenchymal Stem cell). hUCB-MSCs are mesenchymal stem cells from umbilical cord blood. Mesenchymal stem cells are well-known for immunosuppression, anti-inflammatory ability and capable of differentiating into a wide range of cell types. Therefore, FURSTEM-CD Inj. has huge possibility as cell therapy products for plaque-type Psoriasis patients.
FURESTEM-CD Inj. 5.0x10^7 cells FURESTEM-CD Inj. 1.0x10^7 cells FURESTEM-CD Inj. 2.0x10^8 cells
Biological: - FURESTEM-CD Inj.
Patients will be treated FURESTEM-CD Inj. Subcutaneous injection
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.