Safety and Efficacy of UC-MSCs in Patients With Psoriasis Vulgaris
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|ClinicalTrials.gov Identifier: NCT02491658|
Recruitment Status : Unknown
Verified July 2015 by Affiliated Hospital to Academy of Military Medical Sciences.
Recruitment status was: Recruiting
First Posted : July 8, 2015
Last Update Posted : July 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis Vulgaris||Biological: UC-MSCs||Phase 1 Phase 2|
Psoriasis is considered as an incurable immune-mediated inflammatory skin disease. The widely used treatments include topical agents, systemic medications and biologic agents, but all of them have some drawbacks or limitations. Besides, non-standardized treatment or the disease itself may lead transformation to other diseases, which add more importance to finding improved management strategies.
Mesenchymal stem cells (MSCs) are a heterogeneous population of cells that can differentiate into bone, cartilage and fat cells. They have several functions, such as migration to skin lesions, immunomodulation, limitation of autoimmunity and local paracrine effects. It reported MSCs have already been used in some kinds of autoimmune disease, such as systemic lupus erythematosus (SLE), systemic sclerosis, crohn disease, rheumatoid arthritis et al.
In this study, consenting umbilical cords are donated by healthy donors. After several processing steps, UC-MSCs are separated and froze for future infusions. When volunteers are recruited, their condition will be assessed by Psoriasis Activity and Severity Index (PASI) and Dermatology Life Quality Index (DLQI). Then MSCs will be infused according to a standard scheme. After all 6 infusions, the patient will be re-assessed by the PASI and DLQI and will be followed up for one year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study to Assess Safety and Efficacy of Umbilical Cord Derived Mesenchymal Stem Cells (UC-MSCs) in Patients With Psoriasis Vulgaris|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
Experimental: Treat Psoriasis Vulgaris with UC-MSCs
Subjects in this arm will receive 6 times UC-MSCs infusions (each time 1×10^6/kg) within 8 weeks.
Psoriasis Vulgaris patients will receive 6 times UC-MSCs infusions (each time 1×10^6/kg). The first time to fourth time will be given once a week for successive 4 weeks, then the last two times will be given once every two weeks.
Other Name: umbilical cord derived mesenchymal stem cells
- Change from Baseline in Psoriasis Area and Severity Index (PASI) score at 8 weeks [ Time Frame: baseline and 8 weeks ]PASI score will be assessed at baseline (pre-infusion) and week 8 (right after the sixth UC-MSCs infusion)
- Change from Baseline in Dermatology Life Quality Index (DLQI) score at 8 weeks [ Time Frame: baseline and 8 weeks ]DLQI score will be assessed at baseline (pre-infusion) and week 8 (right after the sixth UC-MSCs infusion)
- body temperature will be monitored for any possible infusion-related toxicities. [ Time Frame: up to 3 months ]
- blood pressure will be monitored for any possible infusion-related toxicities. [ Time Frame: up to 3 months ]
- Psoriasis Area and Severity Index (PASI) score [ Time Frame: month 6, 9, and 12 ]PASI score will be assessed at month 6, 9 and 12 from the first UC-MSC infusion as followed-up.
- Dermatology Life Quality Index (DLQI) score [ Time Frame: month 6, 9, and 12 ]DLQI score will be assessed at month 6, 9 and 12 from the first UC-MSC infusion as followed-up.
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): NCT02491658
|Contact: Chen Hu, Ph.D.||+firstname.lastname@example.org|
|Contact: Zhang Bin, Ph.D.||+email@example.com|
|Affiliated Hospital to Academy of Military Medical Sciences||Recruiting|
|Beijing, Beijing, China, 100071|
|Contact: Hu Chen, Ph.D +86-010-6694-7108 firstname.lastname@example.org|
|Contact: Bin Zhang, Ph.D +86-010-6694-7125 email@example.com|
|Principal Investigator:||Chen Hu, Ph.D||Affiliated Hospital to Academy of Military Medical Sciences|