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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
Sponsor:
Information provided by (Responsible Party):
Affiliated Hospital to Academy of Military Medical Sciences

Brief Summary:
The purpose of this study is to investigate the safety and efficacy of umbilical cord derived mesenchymal stem cells (UC-MSCs) in patients with moderate to severe psoriasis vulgaris. Any adverse events related to UC-MSCs infusion will be monitored and the patients will be assessed by Psoriasis Activity and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) in the baseline and after MSCs infusions.

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Biological: UC-MSCs Phase 1 Phase 2

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
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.
Biological: 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 Name: umbilical cord derived mesenchymal stem cells




Primary Outcome Measures :
  1. 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)

  2. 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)


Secondary Outcome Measures :
  1. body temperature will be monitored for any possible infusion-related toxicities. [ Time Frame: up to 3 months ]
  2. blood pressure will be monitored for any possible infusion-related toxicities. [ Time Frame: up to 3 months ]
  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of stable psoriasis vulgaris for at least 6 months
  • 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:

  • Other types of psoriasis, such as pustular psoriasis, psoriatic arthritis
  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Chen Hu, Ph.D. +86-010-6694-7108 chenhu217@aliyun.com
Contact: Zhang Bin, Ph.D. +86-010-6694-7125 zb307ctc@163.com

Locations
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China, Beijing
Affiliated Hospital to Academy of Military Medical Sciences Recruiting
Beijing, Beijing, China, 100071
Contact: Hu Chen, Ph.D    +86-010-6694-7108    chenhu217@aliyun.com   
Contact: Bin Zhang, Ph.D    +86-010-6694-7125    zb307ctc@163.com   
Sponsors and Collaborators
Affiliated Hospital to Academy of Military Medical Sciences
Investigators
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Principal Investigator: Chen Hu, Ph.D Affiliated Hospital to Academy of Military Medical Sciences

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Responsible Party: Affiliated Hospital to Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT02491658     History of Changes
Other Study ID Numbers: 307-PV-MSC
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: July 8, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases