Safety and Efficacy of Expanded Allogeneic AD-MSCs in Patients With Moderate to Severe Psoriasis

Psoriasis Clinical Trial

— ADMSP  

Official title:

Safety and Efficacy of Expanded Allogeneic Adipose-derived Mesenchymal Stem Cells in Patients With Moderate to Severe Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03265613
• Other study ID #: S2017-01
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 24, 2017
• Est. completion date: November 28, 2019

Study information

• Verified date: August 2023
• Source: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: November 28, 2019
• Est. primary completion date: August 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Effect
• Drug Toxicity
• Drug-Related Side Effects and Adverse Reactions
• Mesenchymal Stromal Cells
• Psoriasis

Intervention

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.

Locations

Country	Name	City	State
China	Guangdong Provincial Hospital of Traditional Chinese Medicine	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	PASI(Psoriasis Area and Severity Index)	The improvement in PASI score from baseline after treatment	12 weeks (plus or minus 3 days) after treatment
Secondary	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
Secondary	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
Secondary	Pruritus Scores on the Visual Analogue Scale	Pruritus Scores on the Visual Analogue Scale	12 weeks (plus or minus 3 days) after treatment
Secondary	BSA	the Body Surface Area	12 weeks (plus or minus 3 days) after treatment
Secondary	DLQI(Dermatology Life Quality Index)	the Dermatology Life Quality Index	12 weeks (plus or minus 3 days) after treatment