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This is a study in patients with moderate to severe chronic plaque psoriasis.All the participants will be randomized into three groups, high-dose UC-MSCs, low-dose UC-MSCs, or methotrexate group.This study is designed to prove that UC-MSCs is safe and effective.
Psoriasis is a chronic, incurable, immune-mediated dermatological disease, and it is considered that immune system dysregulation is the important cause of the disease.Umbilical cord derived mesenchymal stem cells (UC-MSCs) have be proven safe and effective for the treatment of various intractable autoimmune and inflammatory disorders because of their distinct immunomodulatory properties.
Patients will be randomized into three groups.In one group patients will be treated with 1x10^6 cells/kg in 0,1,2,3,5,7 week, in the second group patients will be treated with 3x10^6 cells/kg in 0,1,2,3,5,7 week,in the third group patients will be treated with 5-25mg Methotrexate from 0 to 15 week In this study, researchers will determine the safety of UC-MSCs that a patient can tolerate without causing side effects. Moreover researchers will also be assess the efficacy and sustainability of UC-MSCs in 52 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-Dose UC-MSCs | Experimental | Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) 1 x 10^6 cells/kg in normal saline injection |
|
| High-Dose UC-MSCs | Experimental | Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) 3 x 10^6 cells/kg in normal saline injection |
|
| Methotrexate | Active Comparator | 5-25mg Methotrexate orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-dose UC-MSCs | Biological | Participants 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（week 0,1,2,3）, then the last two times will be given once every two weeks（week 5,7）. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who have 75% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI75) at week 20 | The proportion of subjects who have a reduction of 75% or more from baseline in the psoriasis area-and-severity index score (PASI 75) at week 20 | Week 20 |
| Proportion of subjects who achieve a score of 0 or 1 on a 5-point Physician's global assessment（PGA0/1) at week 20 | The proportion of subjects who achieve a score of 0（clear）or 1（almost clear）on a 5-point Physician's global assessment（PGA0/1) at week 20 | Week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who have 90% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI90) at week 20 | The proportion of subjects who have a reduction of 90% or more from baseline in the psoriasis area-and-severity index score (PASI 90) at week 20 | Week 20 |
| Proportion of subjects who have 75% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI75) at week 12,16,36,52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Dermatology Life Quality Index (DLQI) score though 52 weeks | DLQI score will be assessed at week 0,1,2,3,5,7,12,16,20,36,52 | Week 0,1,2,3,5,7,12,16,20,36,52 |
| Exploring the theoretical basis of stem cell therapy for psoriasis |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunlei Zhang, doctor | Contact | 86-13716014425 | zhangchunleius@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chunlei Zhang, doctor | Peking University Third Hospital | Study Chair |
| Xin Guan, doctor | Peking University Third Hospital | Principal Investigator |
| Chunting Li, doctor |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | China |
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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|
| High-dose UC-MSCs | Biological | Participants will receive 6 times UC-MSCs infusions (each time 3×10^6/kg). The first time to fourth time will be given once a week for successive 4 weeks（week 0,1,2,3）, then the last two times will be given once every two weeks（week 5,7）. |
|
|
| Methotrexate | Drug | Participants will be administered Methotrexate (each time 5-25mg) orally once a week for successive 16 weeks(week 0-15). |
|
The proportion of subjects who have a reduction of 75% or more from baseline in the psoriasis area-and-severity index score (PASI 75) at week 12,16,36,52 |
| Week 12,16,36,52 |
| Proportion of subjects who achieve a score of 0 or 1 on a 5-point Physician's global assessment（PGA0/1) at week 12,16,36,52 | The proportion of subjects who achieve a score of 0（clear）or 1（almost clear）on a 5-point Physician's global assessment（PGA0/1) at week 12,16,36,52 | Week 12,16,36,52 |
| Frequency of Adverse Events and Serious Adverse Events | Frequency of all Adverse Events (AEs) and Serious Adverse Events (SAEs) that occur during the whole trial including the observational period (AEs and SAEs include but not limited to headaches, allergies, fever and so on | Week 0 through week 52 |
| Proportion of subjects who experience psoriasis relapse | The proportion of subjects who experience a psoriasis relapse at any time until week 52. Psoriasis relapse is defined as loss of > 50% of the initial PASI improvement measured at week 7 | Week 8 though week 52 |
Analysis the serum cytokine content, immunological subgroup and pathological section to explore the theoretical basis of stem cell therapy for psoriasis
| 0,1,2,3,5,7 12,16,20,36,52 week |
| Peking University Third Hospital |
| Principal Investigator |
| Jinzhu Guo, doctor | Peking University Third Hospital | Principal Investigator |
| Wenhui Wang, doctor | Peking University Third Hospital | Study Director |
| Tianjin Ever Union Biotechnology Co., Ltd. | Beijing | China |
|
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |