Safety and Efficacy of UC-MSCs in Patients With Psoriasis Vulgaris
NCT ID: NCT02491658
Last Updated: 2015-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2015-04-30
2016-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
UC-MSCs
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.
Interventions
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UC-MSCs
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Baseline Psoriasis Area and Severity Index (PASI) score \>= 8
* Despite systemic or topical treatment, psoriasis is still in active or recurrent condition
* No other psoriasis management (topical or systemic) during the UC-MSCs infusions
* Willing and able to comply with all study requirements and provide informed consent
Exclusion Criteria
* With other disease
* Systemic treatments within 4 weeks before the baseline visit
* Topical treatment within 2 weeks before the baseline visit
* Uncontrolled active infections
* Evidence of infection with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV)
* History of severe systemic disease or malignancy
* Pregnant or lactating females, or willing to have a baby in the next year
* Cannot be traced on time
* Any other situations not suitable for this study determined by the investigators
18 Years
65 Years
ALL
No
Sponsors
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Affiliated Hospital to Academy of Military Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Chen Hu, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Affiliated Hospital to Academy of Military Medical Sciences
Locations
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Affiliated Hospital to Academy of Military Medical Sciences
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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307-PV-MSC
Identifier Type: -
Identifier Source: org_study_id
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