Localized scleroderma with hardening of the skin on the head, face, and limbs
Conditions
Interventions
control group:NA
experimental group:Adipose derived mesenchymal stem cells
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18 to 60 years old (including threshold), gender is not limited. 2. Diagnosed as patchy, linear, or generalized focal scleroderma, with lesions limited to the head, face, and/or limbs. 3. The target lesion is in the inflammatory or sclerosing phase; 4. The researchers believe that the subjects are able to understand the study, cooperate with the research procedures, and are willing to return to the research center for the necessary follow-up. 5. Participants who voluntarily participate in the trial, understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Localized scleroderma combined with other autoimmune diseases, such as polymyositis, dermatomyositis, systemic sclerosis, rheumatoid arthritis, systemic lupus erythematosus, or Sjogren's syndrome; Subjects who require systemic immunosuppressive therapy during the screening and trial periods. 2. Localized scleroderma can cause joint involvement (joint pain, joint deformities, or limited mobility, etc.) or skeletal dysfunction. 3. Focal scleroderma causes central nervous system involvement (migraine, hemiplegia, epilepsy, etc.). 4. Localized scleroderma can cause abnormal vision or eye movement. 5. Symptoms of severe, progressive, or uncontrollable kidney, liver, hematological, gastrointestinal, lung, psychiatric, cardiac, neurological, or brain disorders during screening, including severe and uncontrollable infections such as sepsis and opportunistic infections. 6. Screening of subjects diagnosed with malignant tumors within the previous 5 years; Subjects with abnormal tumor marker detection results assessed by researchers as having tumor risk. 7. Subjects with positive serum virology (HBsAg, HCV antibody, HIV antibody, Treponema pallidum antibody), including hepatitis B B virus carriers, hepatitis B patients who were stable after drug treatment (HBV DNA2.0 × upper limit of normal (ULN) during screening; Total bilirubin>2.0 × ULN during screening; Estimated glomerular filtration rate (eGFR)<40mL/min/1.73m^2, or any uncontrolled clinically significant laboratory test abnormalities that may affect the interpretation of study data or subject participation in the study. 9. Subjects who have received autologous fat transplantation or other invasive treatments (such as skin flap transplantation) for the target lesion within 6 months prior to administration. 10. Subjects who have previously received stem cell therapy for focal scleroderma. 11. For focal scleroderma, received local topical treatment (corticosteroids, calcipotriol, tacrolimus, imiquimod, and lukotinib) within one month prior to enrollment; Received phototherapy (UVA1, PUVA, narrowband UVB) within one month prior to enrollment; Received laser treatment (pulsed dye laser (PDL), segmented laser (CO2, erbium YAG), neodymium YAG laser) within one month before enrollment; Received systemic therapy (glucocorticoids, methotrexate, mycophenolate mofetil/mycophenolate mofetil, abazil, JAK inhibitors, tocilizumab, etc.) within the first 3 months of enrollment. 12. Subjects who have received intervention therapy with chemical or biological research products within the first 3 months of enrollment for focal scleroderma. 13. For focal scleroderma, we have received traditional Chinese patent medicines and simple preparations (Fusong Tablets, Resuscitation Tablets, Fukang Tablets, Xuefusheng Tablets, Asiaticoside Tablets, etc.) within 2 weeks before enrollment. The participants; 14. Pregnant or lactating women, or subjects with positive pregnancy tests during screening, or subjects who are unable and unwilling to take effective contraceptive measures during the study period. 15. The subject currently has drug or alcohol addiction issues. 16. Ind
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy endpoint; | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy endpoint; | — |
Countries
China
Contacts
Public Contactxiaolong
Peking Union Medical College Hospital
Outcome results
None listed