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Clinical study of lipid matrix vascular component/Extracellular matrix Gel (ECM/SVF-gel) on skin fibrosis in scleroderma

Clinical study of lipid matrix vascular component/Extracellular matrix Gel (ECM/SVF-gel) on skin fibrosis in scleroderma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058003
Enrollment
Unknown
Registered
2022-03-26
Start date
2022-04-01
Completion date
Unknown
Last updated
2023-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

scleroderma

Interventions

Experimental Group A:Traditional fat grafting and sequential injection of adipose stromal vascular components/adhesive extracellular matrix
Experimental Group B:Traditional fat grafting

Sponsors

Nanfang Hospital, Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 59 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily sign informed consent; 2. Aged 18-59 years, gender unlimited; 3. The BMI > = 17; 4. Patients with clinically confirmed localized/systemic scleroderma did not have severe internal organ involvement.

Exclusion criteria

Exclusion criteria: 1. Surgical contraindications; 2. Pregnant or breastfeeding; 3. New vasodilators or immunosuppressive drugs within 3 months; 4. Apply topical ointment to the surgical area within 2 weeks; 5. HIV, HBV or HCV, HTLV-1 or -2, syphilis positive; 6. Patients with a history of tumor formation in the last 5 years; 7. Patients with prednisolone intake greater than 10 mg/d; 8. Patients deemed unsuitable for the study by the investigator.

Design outcomes

Primary

MeasureTime frame
Localized Scleroderma Skin Damage Index (LoSDI) ;modified localized scleroderma skin severity index (mLoSSI);

Secondary

MeasureTime frame
modified Rondnan Skin Score (mRSS);

Countries

China

Contacts

Public ContactLu Feng

Nanfang Hospital, Southern Medical University

406604293@qq.com+86 137 9809 3619

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026