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The purpose of this study is to evaluate the safety and efficacy of Adipose-derived Mesenchymal Stem Cells (AD-MSCs) with moderate to severe psoriasis. Any adverse events related to AD-MSCs infusion will be monitored. Safety is assessed using incidence of Adverse Events(AEs) and Serious Adverse Events (SAEs). Efficacy is assessed via the proportion of the improvement of PASI (Psoriasis Area and Severity Index), relapse rate in treatment period, changes in PASI score and BSA, as well as DLQI.
Psoriasis is an immune-mediated, genetic disease manifesting in the skin or joints or both. Numerous topical and systemic therapies are available for the treatment of psoriasis. Treatment modalities are chosen on the basis of disease severity, relevant comorbidities, patient preference. For moderate to severe psoriasis, phototherapy, systemic therapy and biologic immune modifying agents are recommended, but all of them have some drawbacks or limitations. Until now, no curative treatment is available. Therefore, it is important to find new treatment for psoriasis.
Mesenchymal stem cells (MSCs) are a kind of adult stem cells that can differentiate into bone, cartilage and adipose cells. Adipos-derived Mesenchymal Stem Cells(AD-MSCs) were isolated from fat tissues and were reported to treat moderate to severe psoriasis vulgaris and psoriasis arthritis successfully by case reports. For the mechanism of the disease, involvement of the immune system in psoriasis is now widely accepted. Mesenchymal stem cells (MSCs) are found to have the function of immunomodulation, migration to skin lesions, limitation of autoimmunity. Therefore, investigators supposed that the injection of AD-MSCs could be beneficial for treatment of moderate to severe psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AD-MSCs group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adipose-derived multipotent mesenchymal stem cells | Biological | AD-MSCs(adipose-derived multipotent mesenchymal stem cells) were infused intravenously at a dose of 0.5 million cells/kg. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) related to intervention | The proportion of the adverse events related to intervention in the treatment group. | 12 weeks (plus or minus 3 days) after treatment |
| Incidence of serious adverse events (SAEs) related to intervention | The proportion of the serious adverse events related to intervention in the treatment group. | 12 weeks (plus or minus 3 days) after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement rate of PASI(Psoriasis Area and Severity Index) | The proportion of the improvement of PASI(Psoriasis Area and Severity Index) from baseline | 12 weeks (plus or minus 3 days) after treatment |
| PASI(Psoriasis Area and Severity Index) |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Chuanjian Lu | Guangdong Provincial Hospital of Traditional Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial Hospital of Traditional Chinese Medicine | Guangzhou | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34988162 | Result | Yao D, Ye S, He Z, Huang Y, Deng J, Wen Z, Chen X, Li H, Han Q, Deng H, Zhao RC, Lu C. Adipose-derived mesenchymal stem cells (AD-MSCs) in the treatment for psoriasis: results of a single-arm pilot trial. Ann Transl Med. 2021 Nov;9(22):1653. doi: 10.21037/atm-21-5028. |
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|
The improvement in PASI score from baseline after treatment
| 12 weeks (plus or minus 3 days) after treatment |
| PASI-50 | The proportion of patients who achieve at least 50% improvement in PASI score from baseline. | 12 weeks (plus or minus 3 days) after treatment |
| PASI-75 | The proportion of patients who achieve at least 75% improvement in PASI score from baseline. | 12 weeks (plus or minus 3 days) after treatment |
| Pruritus Scores on the Visual Analogue Scale | Pruritus Scores on the Visual Analogue Scale | 12 weeks (plus or minus 3 days) after treatment |
| BSA | the Body Surface Area | 12 weeks (plus or minus 3 days) after treatment |
| DLQI(Dermatology Life Quality Index) | the Dermatology Life Quality Index | 12 weeks (plus or minus 3 days) after treatment |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D064419 | Chemically-Induced Disorders |
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