Comparing two traditional Chinese medicine formulas with stem cells for psoriasis treatment
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
This study is testing two traditional Chinese medicine formulas combined with stem cells to see if they can help people with moderate to severe psoriasis feel better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Guangdong Provincial Hospital of Traditional Chinese Medicine Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04785027 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of two different traditional Chinese medicine formulas, PSORI-CM01 and Gu Ben Hua Yu, when combined with expanded allogeneic adipose-derived mesenchymal stem cells (AD-MSCs) in patients suffering from moderate to severe psoriasis. It aims to determine how these treatments compare in managing the condition and to gather patient expectations regarding the use of traditional medicine combined with stem cells. The trial will enroll 16 subjects and will include interviews to assess their experiences and expectations. The findings will provide preliminary data for future larger randomized controlled trials.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 with moderate to severe psoriasis.
Not a fit: Patients with specific types of psoriasis, acute progressive psoriasis, or significant psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new treatment option for patients with moderate to severe psoriasis.
How similar studies have performed: While the combination of traditional Chinese medicine and stem cells is a novel approach, there is limited existing research on its efficacy in treating psoriasis.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Guangdong Provincial Hospital of Traditional Chinese Medicine — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Chuanjian Lu, PhD — Guangdong Provincial Hospital of Traditional Chinese Medicine
- Study coordinator: Chuanjian Lu, PhD
- Email: luchuanjian888@vip.sina.com
- Phone: +8620-81887233-31223
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.