Clinical trial NCT02975960: ADMSCs for the Treatment of Systemic Sclerosis
Official title: Adipose Tissue-derived Mesenchymal Stem Cells for Cell-based Therapy in the Treatment of Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Sclerosis
Keywords: systemic sclerosis
adipose derived stem cell
stromal vascular fraction
digital ulcer
gangrene
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
Collaborators: name: Seoul St. Mary's Hospital
First posted: 2016-11-29
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline modified Rodnan Skin score (mRSS) of hands at 12 weeks
timeFrame: baseline, 12 weeks
Secondary outcomes:
measure: Change from baseline Raynaud's condition score at 12 weeks
timeFrame: baseline, 12 weeks
measure: Change from baseline Visual Analog Score for pain the hands at 12 weeks
timeFrame: baseline, 12 weeks
measure: Changes from baseline mRSS (total) at 12 weeks
timeFrame: baseline, 12 weeks
measure: Change from baseline Kapandji score at 12weeks
timeFrame: baseline, 12 weeks
measure: Change from baseline Cochin hand function scale at 12 weeks
timeFrame: baseline, 12 weeks
measure: Change from baseline Systemic sclerosis HAQ at 12 weeks
timeFrame: baseline, 12 weeks
measure: Change from baseline peripheral vasculature at 12 weeks
timeFrame: baseline, 12 weeks
measure: Change from baseline finger circumference at 12 weeks
timeFrame: baseline, 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's hospital
Study officials:
affiliation: Seoul St.Mary's hospital, The Catholic university of Korea
name: Jung Hee Koh, MD
role: PRINCIPAL_INVESTIGATOR
References: