Mesenchymal Stromal Cells, Psoriasis, Drug Toxicity, Drug Effect
Conditions
Brief summary
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.
Detailed description
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.
Interventions
AD-MSCs(adipose-derived multipotent mesenchymal stem cells) were infused intravenously at a dose of 0.5 million cells/kg.
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs) related to intervention | 12 weeks (plus or minus 3 days) after treatment | The proportion of the adverse events related to intervention in the treatment group. |
| Incidence of serious adverse events (SAEs) related to intervention | 12 weeks (plus or minus 3 days) after treatment | The proportion of the serious adverse events related to intervention in the treatment group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PASI-50 | 12 weeks (plus or minus 3 days) after treatment | The proportion of patients who achieve at least 50% improvement in PASI score from baseline. |
| PASI-75 | 12 weeks (plus or minus 3 days) after treatment | The proportion of patients who achieve at least 75% improvement in PASI score from baseline. |
| Improvement rate of PASI(Psoriasis Area and Severity Index) | 12 weeks (plus or minus 3 days) after treatment | The proportion of the improvement of PASI(Psoriasis Area and Severity Index) from baseline |
| BSA | 12 weeks (plus or minus 3 days) after treatment | the Body Surface Area |
| DLQI（Dermatology Life Quality Index） | 12 weeks (plus or minus 3 days) after treatment | the Dermatology Life Quality Index |
| Pruritus Scores on the Visual Analogue Scale | 12 weeks (plus or minus 3 days) after treatment | Pruritus Scores on the Visual Analogue Scale |
| PASI(Psoriasis Area and Severity Index) | 12 weeks (plus or minus 3 days) after treatment | The improvement in PASI score from baseline after treatment |
Countries
China
Outcome results
None listed