Comparison of PSORI-CM01 Formula vs Gu Ben Hua Yu Formula Combined With AD-MSCs in Psoriasis

Psoriasis Clinical Trial

Official title:

Comparison of PSORI-CM01 Formula vs Gu Ben Hua Yu Formula Combined With Expanded Allogeneic Adipose-derived Mesenchymal Stem Cells in Patients With Moderate to Severe Psoriasis: a Pilot Study for a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04785027
• Other study ID #: S2020-01-01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 17, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: August 2023
• Source: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Contact: Chuanjian Lu, PhD
• Phone: +8620-81887233-31223
• Email: luchuanjian888[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate and compare the safety and efficacy of PSORI-CM01 formula vs Gu Ben Hua Yu formula combined with Expanded Allogeneic AD-MSCs in patients with moderate to severe psoriasis. And it explores the expectations of patients for the treatment of traditional Chinese medicine combined with stem cells and their expectations to participate in this study. The trial would provide preliminary data for large sample clinical randomized controlled trials.

Description:

Psoriasis is an immune-mediated, genetic disease manifesting in the skin or joints or both. 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.

As current experience and cases of AD-MSCs in the treatment of psoriasis are still relatively small, and it is unknown about their safety and efficacy combined with traditional medicine in the treatment of psoriasis.

This study designed a randomized controlled trial to compare PSORI-CM01 formula vs Guben Huayu formula combined with expanded allogeneic adipose-derived mesenchymal stem cells in the treatment of psoriasis. The purpose of this study is to evaluate and compare the safety and efficacy of PSORI-CM01 formula vs Gu Ben Hua Yu formula combined with Expanded Allogeneic AD-MSCs in patients with moderate to severe psoriasis. And it also aims to determine the feasibility and the potential of the protocol for the full-scale randomized controlled trial (RCT).

Therefore, 16 subjects will be enrolled in this study and their expectations for the treatment of traditional Chinese medicine combined with stem cells and their experience to participate in this study will be interviewed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: September 30, 2024
• Est. primary completion date: June 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1.patients with psoriasis vulgaris(PASI > 7 or BSA >10%); 2.18 to 65 years old; 3.written/signed informed consent.

Exclusion Criteria:

1. The skin lesions are seen alone on the patient's face, scalp, nails, wrinkles, glans, mucous membranes, palmar and plantar or guttate psoriasis;

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 Safety
• Mesenchymal Stromal Cells
• Psoriasis
• Traditional Chinese Medicine

Intervention

Drug:
• PSORI-CM01 formula
PSORI-CM01 formula will be orally administrated once a day for 12 weeks excpet the day for the infusion of AD-MSCs
• Gu Ben Hua Yu formula
Gu Ben Hua Yu formula will be orally administrated once a day for 12 weeks excpet the day for the infusion of AD-MSCs

Biological:
• adipose-derived multipotent mesenchymal stem cells
AD-MSCs (adipose-derived multipotent mesenchymal stem cells) will be infused intravenously at a dose of 2 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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PASI score improvement rate	PASI score improvement rate = (PASI score before intervention - PASI score after intervention)/PASI score before intervention ×100% PASI scores the average redness, thickness, and scaliness of the lesions (0-4 scale), weighted by the area of involvement. PASI scores range from 0 to 72. The higher the score, the worse the disease.	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. PASI scores the average redness, thickness, and scaliness of the lesions (0-4 scale), weighted by the area of involvement. PASI scores range from 0 to 72. The higher the score, the worse the disease.	12 weeks (plus or minus 3 days) after treatment.
Secondary	Relapse rate in treatment period / follow-up period	Relapse can be defined only for patients who achieve PASI-50,and occurs when the improvement in the PASI score falls below 50 percent from the baseline PASI score.	12 weeks (plus or minus 3 days) after treatment.
Secondary	PASI-50	The proportion of patients who achieve at least 50 percent 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 percent improvement in PASI score from baseline.	12 weeks (plus or minus 3 days) after treatment.
Secondary	Pruritus Scores on the Visual Analogue Scale	Pruritus was assessed using the Visual Analogue Scales; The Scale scores ranged from 0-10. The higer the scores were, the more itching the patient suffered.	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 score of Dermatology Life Quality Index. Dermatology Life Quality Index (DLQI) is a self-administered 10-item questionnaire. It covers Symptoms and feelings, Daily activities, Leisure, Work and school, Personal relationships, and Treatment. The higher the score, the worse the quality of life.	12 weeks (plus or minus 3 days) after treatment.