Clinical trial NCT04785027: Comparison of PSORI-CM01 Formula vs Gu Ben Hua Yu Formula Combined With AD-MSCs in Psoriasis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Traditional Chinese Medicine
Drug Effect
Drug Safety
Psoriasis
Mesenchymal Stromal Cells
Keywords: Traditional Chinese Medicine
Mesenchymal Stem Cells
Psoriasis
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: PASI score improvement rate
timeFrame: 12 weeks (plus or minus 3 days) after treatment.
Secondary outcomes:
measure: PASI (Psoriasis Area and Severity Index)
timeFrame: 12 weeks (plus or minus 3 days) after treatment.
measure: Relapse rate in treatment period / follow-up period
timeFrame: 12 weeks (plus or minus 3 days) after treatment.
measure: PASI-50
timeFrame: 12 weeks (plus or minus 3 days) after treatment.
measure: PASI-75
timeFrame: 12 weeks (plus or minus 3 days) after treatment.
measure: Pruritus Scores on the Visual Analogue Scale
timeFrame: 12 weeks (plus or minus 3 days) after treatment.
measure: BSA
timeFrame: 12 weeks (plus or minus 3 days) after treatment.
measure: DLQI (Dermatology Life Quality Index)
timeFrame: 12 weeks (plus or minus 3 days) after treatment.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Traditional Chinese Medicine
state: Guangdong
Study officials:
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Chuanjian Lu, PhD
role: PRINCIPAL_INVESTIGATOR
References: