Safety of FURESTEM-CD Inj. in Patients With Moderate to Severe Plaque-type Psoriasis
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|ClinicalTrials.gov Identifier: NCT02918123|
Recruitment Status : Not yet recruiting
First Posted : September 28, 2016
Last Update Posted : September 5, 2017
|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.|
|Anticipated Study Start Date :||December 2017|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||December 2020|
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: Mihee Hwangfirstname.lastname@example.org|
|Korea, Republic of|
|The Catholic Univ. Korea Seoul, St. Marry's Hospital||Not yet recruiting|
|Seoul, Korea, Republic of, 06591|
|Contact: Tae-yoon Kim|
|Principal Investigator:||Taeyoon Kim||Seoul St. Mary's Hospital|