Safety of FURESTEM-CD Inj. in Patients With Moderate to Severe Plaque-type Psoriasis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02918123|
Recruitment Status : Recruiting
First Posted : September 28, 2016
Last Update Posted : March 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis||Biological: FURESTEM-CD Inj.||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Clinical Trial to Evaluate the Safety of FURESTEM-CD Inj. in Patients With Moderate to Severe Plaque-type Psoriasis.|
|Actual Study Start Date :||January 17, 2018|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Biological: FURESTEM-CD Inj.
Patients will be treated FURESTEM-CD Inj. Subcutaneous injection
Other Name: hUCB-MSCs
- number of adverse events [ Time Frame: 4 weeks follow-up after treatment ]
- safety lab tests, physical examination, ECG, vital signs [ Time Frame: 4 weeks follow-up after treatment ]
- variation of Cytokine, PASI, BSA [ Time Frame: 4 weeks follow-up after treatment ]
- number of adverse events, safety lab tests, physical examination, vital signs [ Time Frame: 144 weeks follow-up after treatment (Extension study) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918123
|Contact: Eunji Kangemail@example.com|
|Korea, Republic of|
|The Catholic Univ. Korea Seoul, St. Marry's Hospital||Recruiting|
|Seoul, Korea, Republic of, 06591|
|Contact: Tae-yoon Kim|
|Principal Investigator:||Taeyoon Kim||Seoul St. Mary's Hospital|