Safety and Efficacy of UC-MSCs in Patients With Psoriasis Vulgaris

Psoriasis Vulgaris Clinical Trial

Official title:

A Study to Assess Safety and Efficacy of Umbilical Cord Derived Mesenchymal Stem Cells (UC-MSCs) in Patients With Psoriasis Vulgaris

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02491658
• Other study ID #: 307-PV-MSC
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: June 24, 2015
• Last updated: July 3, 2015
• Start date: April 2015
• Est. completion date: December 2016

Study information

• Verified date: July 2015
• Source: Affiliated Hospital to Academy of Military Medical Sciences
• Contact: Chen Hu, Ph.D.
• Phone: +86-010-6694-7108
• Email: chenhu217[@]aliyun.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

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.

Locations

Country	Name	City	State
China	Affiliated Hospital to Academy of Military Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital to Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	body temperature will be monitored for any possible infusion-related toxicities.		up to 3 months	Yes
Secondary	blood pressure will be monitored for any possible infusion-related toxicities.		up to 3 months	Yes
Secondary	Psoriasis Area and Severity Index (PASI) score	PASI score will be assessed at month 6, 9 and 12 from the first UC-MSC infusion as followed-up.	month 6, 9, and 12	No
Secondary	Dermatology Life Quality Index (DLQI) score	DLQI score will be assessed at month 6, 9 and 12 from the first UC-MSC infusion as followed-up.	month 6, 9, and 12	No