ADMSCs for the Treatment of Systemic Sclerosis

The Catholic University of Korea

Status: Completed

Conditions: Systemic Sclerosis

Treatments: Biological: injection of autologous stromal vascular fraction

Study type: Interventional

Funder types: Other

Identifiers

NCT02975960

KC16TISI0343

Details and patient eligibility

About

Systemic sclerosis (SSc) is a rare autoimmune disease, mainly characterized by cutaneous and visceral fibrosis. Digital ulcer and sclerosing skin are commonly affected on hands, but the treatment for these manifestations are often ineffective.

Adipose tissue contains stromal vascular fraction (SVF), which is abundant multipotent stem cells, capable of tissue repair. A prior study (NCT01813279) has shown the safety and tolerance at 6 months of the subcutaneous injection of SVF in the fingers in SSc.

There are only few ways to manage SSc patients with skin lesion who already have treated with several medications (including vasodilators, PDE5 inhibitor, endothelin receptor antagonist) but some times their skin lesions are critical physically and emotionally.

Autologous SVF injection could be one of the treatment options to treat skin lesion of SSc. Thus, the investigators study the efficacy and potential adverse event in Korean patients with SSc.

Full description

In this study, the investigators will inject autologous Stromal vascular fraction.

1. Acquiring autologous stromal vascular fraction by plastic surgeon

1. Liposuction
2. Extraction and purifying SVF using Smart-X system (15-20 min)
3. Making syringe filled with autologous SVF

2. SVF injection

Inject SVF subcutaneously with 25G needle in finger

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients who fulfill 2013 American college of Rheumatology/ European League Against Rheumatism Criteria for the classification of systemic sclerosis.
2. The skin lesion was not improved after 6 months treatment with conventional therapy.

Exclusion criteria

1. Pregnancy
2. Start new medications within 3 months prior to enrollment
3. Previous sympathectomy or amputation
4. Current systemic infection
5. AIDS, Syphilis, hepatitis B&C
6. BMI <17kg/m2
7. Cognitive dysfunction and other psychologic problems

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Stromal vascular fraction injection

Experimental group

Description:

Injection of autologous stromal vascular fraction on hand.

Treatment:

Biological: injection of autologous stromal vascular fraction