Back to resultsClinical Research on Treatment of Psoriasis by Human Umbilical Cord-derived Mesenchymal Stem Cells
Primary Purpose
Psoriasis
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Mesenchymal Stem Cells
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Mesenchymal Stem Cells
Eligibility Criteria
Inclusion Criteria:
1.Understanding the whole process of the study, voluntary participation and signed the informed consent; 2.18 Years to 65 Years old, Body Mass Index (BMI) between 18.5-35; 3.Diagnosed according to biopsy for Psoriasis vulgaris for more than 6 months and resistance to phototherapy, systemic therapy, or a combination of these therapies,BSA(body surface area)>10%, PGA≥3 and PASI>10 at baseline; 4. Patients participated in any stem cell therapy within 6 months;
Exclusion Criteria:
- WBC(white blood cell count ) <3.5x109/L, blood platelet count<100x109/L, hemoglobin<100g/L serum creatinine>1.5 x ULN(upper limit of normal), bilirubin > 1.5 x ULN(upper limit of normal), AST(SGOT,glutamic-oxalacetic transaminase)/ALT(SGPT,glutamic-pyruvic transaminase) >2.0 x ULN(upper limit of normal);Either HIV-antibody(human immunodeficiency virus-antibody), HBV-antibody (hepatitis B virus-antibody ) or syphilis antibody is positive;
- Have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history,Patients suffering from any acute or chronic infectious diseases, patients suffering from malignant tumor; Mental disorders, history of alcohol abuse, drug or other substance abuse;
- Patients who have received systemic therapy within recent one month or topical therapy in two weeks;
- Having a serious allergic history or being allergic to two or more than 2 kinds of food or drugs;
- Pregnant women, or women who ready for pregnancy or lactating; Patients participated in any clinical trials within 3 months; Other cases which researchers believe that can not enroll.
Sites / Locations
- Xiangya Hospital, Central South UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mesenchymal Stem Cells
Arm Description
The mesenchymal stem cells will be derived from human umbilical cord. After the subjects are screened and qualified, random number envelopes will be selected to group 12 subjects into group A, group B, group C and group D at a ratio of 1:1:1:1. The subjects of group A and B will be injected intravenously with 1.5x10E6/kg and 2.0x10E6/kg（according to the weight of subject）mesenchymal stem cells respectively at baseline and every 2 weeks, 4 times is a course of treatment. Subjects will be followed up for evaluation on 15 days, 30 days, 45 days, month 2, month 3 and month 6 after treatment. The subjetcts of group C and D will be injected intravenously with 2.5x10E6/kg and 3.0x10E6/kg （according to the weight of subject）mesenchymal stem cells respectively at baseline and every 4 weeks, 2 times is a course of treatment. Subjects will be followed up for evaluation on 15 days, 30 days, 45 days, month 2, month 3 and month 6 after treatment.
Outcomes
Primary Outcome Measures
Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement
The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 was defined as having an improvement of at least 75% in the PASI scores compared to baseline.
Number of Participants Achieving a Physician Global Assessment (PGA) of (0, 1)
The PGA is a physician's determination of the participant's psoriasis lesions overall categorized by descriptions for induration, erythema, and scaling.
Secondary Outcome Measures
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant. Least Square (LS) Means in total DLQI score were calculated using Mixed Model Repeated Measures (MMRM) with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.
Adverse event
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Full Information
NCT ID
NCT03765957
First Posted
August 28, 2018
Last Updated
September 22, 2020
Sponsor
Central South University
1. Study Identification
Unique Protocol Identification Number
NCT03765957
Brief Title
Clinical Research on Treatment of Psoriasis by Human Umbilical Cord-derived Mesenchymal Stem Cells
Official Title
Clinical Research on Treatment of Psoriasis by Human Umbilical Cord-derived Mesenchymal Stem Cells
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 20, 2019 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
June 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central South University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the effect and safety of treatment of psoriasis by human umbilical cord-derived mesenchymal stem cel
Detailed Description
Psoriasis is a chronic and recurrent inflammatory skin disease and its histological features are characterized by epidermal hyperplasia, increased angiogenesis and immune cell infiltration. Psoriasis prevalence is about 0.1%-3%, affecting approximately 125 million people worldwide. In China, there are about 10 million psoriasis patients.
Human umbilical cord-derived MSC (huc-MSC) has many advantages for the treatment of immune disease. Because it was demonstrated that huc-MSCs are effective in modulating immune cells and treating diseases and it has low immunogenicity. Furthermore, huc-MSCs do not raise ethical issue for clinical applications.
Some experimental results and cases has showed that mesenchymal stem cell (MSC) can prevent or treat psoriasis. This clinical study is conducted to provide more data to evaluate the effect and safety of treatment of psoriasis by human umbilical cord-derived mesenchymal stem cell.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Mesenchymal Stem Cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mesenchymal Stem Cells
Arm Type
Experimental
Arm Description
The mesenchymal stem cells will be derived from human umbilical cord. After the subjects are screened and qualified, random number envelopes will be selected to group 12 subjects into group A, group B, group C and group D at a ratio of 1:1:1:1. The subjects of group A and B will be injected intravenously with 1.5x10E6/kg and 2.0x10E6/kg（according to the weight of subject）mesenchymal stem cells respectively at baseline and every 2 weeks, 4 times is a course of treatment. Subjects will be followed up for evaluation on 15 days, 30 days, 45 days, month 2, month 3 and month 6 after treatment. The subjetcts of group C and D will be injected intravenously with 2.5x10E6/kg and 3.0x10E6/kg （according to the weight of subject）mesenchymal stem cells respectively at baseline and every 4 weeks, 2 times is a course of treatment. Subjects will be followed up for evaluation on 15 days, 30 days, 45 days, month 2, month 3 and month 6 after treatment.
Intervention Type
Biological
Intervention Name(s)
Mesenchymal Stem Cells
Other Intervention Name(s)
Human Umbilical Cord-derived Mesenchymal Stem Cells
Intervention Description
After the subjects are screened and qualified, random number envelopes will be selected to group 12 subjects into group A, group B, group C and group D at a ratio of 1:1:1:1. The subjetcts of group A and B will be injected intravenously with 1.5x10E6/kg and 2.0x10E6/kg（according to the weight of subject）mesenchymal stem cells respectively at baseline and every 2 weeks, 4 times is a course of treatment. Subjects will be followed up for evaluation on 15 days, 30 days, 45 days, month 2, month 3 and month 6 after treatment. The subjetcts of group C and D will be injected intravenously with 2.5x10E6/kg and 3.0x10E6/kg （according to the weight of subject）mesenchymal stem cells respectively at baseline and every 4 weeks, 2 times is a course of treatment. Subjects will be followed up for evaluation on 15 days, 30 days, 45 days, month 2, month 3 and month 6 after treatment. Besides MSCs, moisturizers such as boric acid ointment will be given to all subjects.
Primary Outcome Measure Information:
Title
Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement
Description
The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 was defined as having an improvement of at least 75% in the PASI scores compared to baseline.
Time Frame
Month 6
Title
Number of Participants Achieving a Physician Global Assessment (PGA) of (0, 1)
Description
The PGA is a physician's determination of the participant's psoriasis lesions overall categorized by descriptions for induration, erythema, and scaling.
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
Description
The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant. Least Square (LS) Means in total DLQI score were calculated using Mixed Model Repeated Measures (MMRM) with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.
Time Frame
Baseline, Month 6
Title
Adverse event
Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time Frame
Baseline, Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1.Understanding the whole process of the study, voluntary participation and signed the informed consent; 2.18 Years to 65 Years old, Body Mass Index (BMI) between 18.5-35; 3.Diagnosed according to biopsy for Psoriasis vulgaris for more than 6 months and resistance to phototherapy, systemic therapy, or a combination of these therapies,BSA(body surface area)>10%, PGA≥3 and PASI>10 at baseline; 4. Patients participated in any stem cell therapy within 6 months;
Exclusion Criteria:
WBC(white blood cell count ) <3.5x109/L, blood platelet count<100x109/L, hemoglobin<100g/L serum creatinine>1.5 x ULN(upper limit of normal), bilirubin > 1.5 x ULN(upper limit of normal), AST(SGOT,glutamic-oxalacetic transaminase)/ALT(SGPT,glutamic-pyruvic transaminase) >2.0 x ULN(upper limit of normal);Either HIV-antibody(human immunodeficiency virus-antibody), HBV-antibody (hepatitis B virus-antibody ) or syphilis antibody is positive;
Have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history,Patients suffering from any acute or chronic infectious diseases, patients suffering from malignant tumor; Mental disorders, history of alcohol abuse, drug or other substance abuse;
Patients who have received systemic therapy within recent one month or topical therapy in two weeks;
Having a serious allergic history or being allergic to two or more than 2 kinds of food or drugs;
Pregnant women, or women who ready for pregnancy or lactating; Patients participated in any clinical trials within 3 months; Other cases which researchers believe that can not enroll.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mi Zhang, M.D. Ph.D
Phone
08615116331788
Ext
08615116331788
Email
648979182@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yehong Kuang, M.D. Ph.D
Phone
08613574171102
Ext
08613574171102
Email
yh_927@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiang Chen, M.D. Ph.D
Organizational Affiliation
Xiangya Hospital of Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mi Zhang, M.D. Ph.D
Phone
08615116331788
Ext
08615116331788
Email
648979182@qq.com
First Name & Middle Initial & Last Name & Degree
Yehong Kuang, M.D. Ph.D
Phone
08613574171102
Ext
08613574171102
Email
yh_927@126.com
First Name & Middle Initial & Last Name & Degree
Xiang Chen, M.D. Ph.D
First Name & Middle Initial & Last Name & Degree
Mi Zhang, M.D. Ph.D
First Name & Middle Initial & Last Name & Degree
Yehong Kuang, M.D. Ph.D
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
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29606893
Citation
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Results Reference
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Citation
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Results Reference
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Learn more about this trial
Clinical Research on Treatment of Psoriasis by Human Umbilical Cord-derived Mesenchymal Stem Cells
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