NCT02491658

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 8, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 8, 2015

Status Verified

July 1, 2015

Enrollment Period

1.7 years

First QC Date

June 24, 2015

Last Update Submit

July 3, 2015

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline in Psoriasis Area and Severity Index (PASI) score at 8 weeks

    PASI score will be assessed at baseline (pre-infusion) and week 8 (right after the sixth UC-MSCs infusion)

    baseline and 8 weeks

  • Change from Baseline in Dermatology Life Quality Index (DLQI) score at 8 weeks

    DLQI score will be assessed at baseline (pre-infusion) and week 8 (right after the sixth UC-MSCs infusion)

    baseline and 8 weeks

Secondary Outcomes (4)

  • body temperature will be monitored for any possible infusion-related toxicities.

    up to 3 months

  • blood pressure will be monitored for any possible infusion-related toxicities.

    up to 3 months

  • Psoriasis Area and Severity Index (PASI) score

    month 6, 9, and 12

  • Dermatology Life Quality Index (DLQI) score

    month 6, 9, and 12

Study Arms (1)

Treat Psoriasis Vulgaris with UC-MSCs

EXPERIMENTAL

Subjects in this arm will receive 6 times UC-MSCs infusions (each time 1×10\^6/kg) within 8 weeks.

Biological: UC-MSCs

Interventions

UC-MSCsBIOLOGICAL

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.

Also known as: umbilical cord derived mesenchymal stem cells
Treat Psoriasis Vulgaris with UC-MSCs

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital to Academy of Military Medical Sciences

Beijing, Beijing Municipality, 100071, China

RECRUITING

Study Officials

  • Chen Hu, Ph.D

    Affiliated Hospital to Academy of Military Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen Hu, Ph.D.

CONTACT

+86-010-6694-7108chenhu217@aliyun.com

Zhang Bin, Ph.D.

CONTACT

+86-010-6694-7125zb307ctc@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2015

First Posted

July 8, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

July 8, 2015

Record last verified: 2015-07

Locations

CN(1)