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Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment in Patients With Moderate to Severe Psoriasis

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ClinicalTrials.gov Identifier: NCT03392311
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Chuanjian Lu, Guangdong Provincial Hospital of Traditional Chinese Medicine

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of Adipose derived Mesenchymal Stem Cells (AD-MSCs) plus Calpocitriol Ointment with moderate to severe psoriasis. Any adverse events related to AD-MSCs infusion will be monitored.The primary outcome is the reduction rate of PASI(Psoriasis Area and Severity Index) and treatment response will be computed from PASI before and after treatment.

Condition or disease Intervention/treatment Phase
Mesenchymal Stromal Cells Psoriasis Drug Effect Drug Toxicity Drug: Calcipotriol ointment Biological: adipose-derived multipotent mesenchymal stem cells Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Expanded Allogeneic Adipose-derived Mesenchymal Stem Cells Plus Calpocitriol Ointment in Patients With Moderate to Severe Psoriasis
Actual Study Start Date : January 17, 2018
Estimated Primary Completion Date : September 15, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: AD-MSCs plus Calcipotriol ointment group
AD-MSCs(adipose-derived multipotent mesenchymal stem cells ) intravenous injection at a dose of 0.5 million cells/kg at week 0,week 4,week 8 with a duration for treatment for 12 weeks. The topical treatment in the study was calcipotriol ointment(Dovonex;LEO Laboratories Ltd, Ireland) twice daily for 12 weeks.
Drug: Calcipotriol ointment
The topical treatment in the study was calcipotriol ointment(Dovonex;LEO Laboratories Ltd, Ireland) twice daily for 12 weeks.

Biological: adipose-derived multipotent mesenchymal stem cells
AD-MSCs(adipose-derived multipotent mesenchymal stem cells) were infused intravenously at a dose of 0.5 million cells/kg.
Other Name: AD-MSCs




Primary Outcome Measures :
  1. Improvement rate of PASI(Psoriasis Area and Severity Index) [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]
    The proportion of the improvement of PASI(Psoriasis Area and Severity Index) from baseline


Secondary Outcome Measures :
  1. PASI(Psoriasis Area and Severity Index) [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]
    The improvement in PASI score from baseline after treatment

  2. Relapse rate in treatment period / follow-up period [ Time Frame: During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period ]
    Relapse can be defined only for patients who achieve PASI50,and occurs when the improvement in the PASI score falls below 50% from the baseline PASI score.

  3. PASI-50 [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]
    The proportion of patients who achieve at least 50% improvement in PASI score from baseline

  4. PASI-75 [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]
    The proportion of patients who achieve at least 75% improvement in PASI score from baseline

  5. Pruritus Scores on the Visual Analogue Scale [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]
    Pruritus was assessed using the Visual Analogue Scales; The Scale scores ranged from 0-10. The higer the scores were, the more itching the patient suffered.

  6. BSA [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]
    the Body Surface Area

  7. DLQI(Dermatology Life Quality Index) [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]
    the Dermatology Life Quality Index



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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:

  1. moderate to severe psoriasis vulgaris ( PASI > 10 or BSA >10%)
  2. 18 to 65 years old
  3. written/signed informed consent

Exclusion Criteria:

  1. guttate psoriasis, inverse psoriasis or exclusively associated with the face
  2. Acute progressive psoriasis, and erythroderma tendency
  3. current (or within 1 year) pregnancy or lactation
  4. current significant anxiety or depression with the Self-rating Anxiety Scale (SAS) > 50 or the Self-rating Depression Scale (SDS) > 53, or with other psychiatric disorders
  5. With history of primary cardiovascular, respiratory, digestive, urinary, endocrinologic and hematologic diseases, which can't be controlled through ordinary treatments. Those who with malignant diseases, infections, electrolyte imbalance, acid-base disturbance. Patients with clinical test results listed below: abnormal serum calcium level ( Ca2+ > 2.9 mmol/L or < 2 mmol/L);AST or ALT 2 times more than normal upper limit; Creatinine and cystatin C more than normal upper limit; Hemoglobin elevates 20g/L more than normal upper limit,or hemoglobin reduction to anemia; Platelet count less than 75.0*10^9/L; White blood cell less than 3.0*10^9/L; Or any other abnormal laboratory test results, assessed by investigators, that are not suitable for this clinical study
  6. Patients with malignant tumors, or when they were enrolled with abnormal tumor markers or with other organ dysfunction
  7. allergy to anything else ever before;
  8. current registration in other clinical trials or participation within a month;
  9. topical treatments (i.e. corticosteroids or retinoic acid or Vitamin D analogs ) within 2 weeks; systemic therapy or phototherapy (ultraviolet radiation B,UVB) and psoralen combined with ultraviolet A (PUVA) within 4 weeks; biological therapy within 12 weeks;
  10. medical conditions assessed by investigators, that are not suitable for this clinical study.

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): NCT03392311


Contacts
Contact: Chuanjian Lu, PhD +8620-81887233-31223 luchuanjian888@vip.sina.com
Contact: Danni Yao, PhD +8620-81887233-35934 yaodanni1984@163.com

Locations
China, Guangdong
Guangdong Provincial Hospital of Traditional Chinese Medicine Recruiting
Guangzhou, Guangdong, China
Contact: Chuanjian Lu, Doctor    (8620)81887233 ext 31223    luchuanjian888@vip.sina.com   
Contact: Zehuai Wen, Doctor    (86)13903008091    wenzehuai@139.com   
Principal Investigator: Chuanjian Lu, Doctor         
Sub-Investigator: Danni Yao         
Sponsors and Collaborators
Guangdong Provincial Hospital of Traditional Chinese Medicine
Investigators
Principal Investigator: Chuanjian Lu, PhD Guangdong Provincial Hospital of Traditional Chinese Medicine

Responsible Party: Chuanjian Lu, Professor, Guangdong Provincial Hospital of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03392311     History of Changes
Other Study ID Numbers: S2016-04-02
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Psoriasis
Drug-Related Side Effects and Adverse Reactions
Skin Diseases, Papulosquamous
Skin Diseases
Chemically-Induced Disorders
Calcipotriene
Calcitriol
Dermatologic Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents