ADMSCs for the Treatment of Systemic Sclerosis
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|ClinicalTrials.gov Identifier: NCT02975960|
Recruitment Status : Completed
First Posted : November 29, 2016
Last Update Posted : January 25, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Systemic Sclerosis||Biological: injection of autologous stromal vascular fraction||Not Applicable|
In this study, the investigators will inject autologous Stromal vascular fraction.
1) Acquiring autologous stromal vascular fraction by plastic surgeon
- Extraction and purifying SVF using Smart-X system (15-20 min)
- Making syringe filled with autologous SVF
2) SVF injection
Inject SVF subcutaneously with 25G needle in finger
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adipose Tissue-derived Mesenchymal Stem Cells for Cell-based Therapy in the Treatment of Systemic Sclerosis|
|Actual Study Start Date :||October 25, 2016|
|Actual Primary Completion Date :||October 30, 2017|
|Actual Study Completion Date :||January 20, 2018|
Experimental: Stromal vascular fraction injection
Injection of autologous stromal vascular fraction on hand.
Biological: injection of autologous stromal vascular fraction
- Change from baseline modified Rodnan Skin score (mRSS) of hands at 12 weeks [ Time Frame: baseline, 12 weeks ]Assess hands mRSS
- Change from baseline Raynaud's condition score at 12 weeks [ Time Frame: baseline, 12 weeks ]The severity (frequency and intensity of crises) of Raynaud's phenomenon
- Change from baseline Visual Analog Score for pain the hands at 12 weeks [ Time Frame: baseline, 12 weeks ]Patient report hand pain degree, comparing baseline and 12 weeks
- Changes from baseline mRSS (total) at 12 weeks [ Time Frame: baseline, 12 weeks ]Assess total mRSS (including hands)
- Change from baseline Kapandji score at 12weeks [ Time Frame: baseline, 12 weeks ]assess the mobility of both hands
- Change from baseline Cochin hand function scale at 12 weeks [ Time Frame: baseline, 12 weeks ]Assess hand function (patients reported outcome)
- Change from baseline Systemic sclerosis HAQ at 12 weeks [ Time Frame: baseline, 12 weeks ]he quality of life- score adapted to systemic sclerosis
- Change from baseline peripheral vasculature at 12 weeks [ Time Frame: baseline, 12 weeks ]Assess peripheral vascularity by Nailfold capillaroscopy
- Change from baseline finger circumference at 12 weeks [ Time Frame: baseline, 12 weeks ]Measure second to fifth finger circumference
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02975960
|Korea, Republic of|
|Seoul St. Mary's hospital|
|Seoul, Korea, Republic of, 06591|
|Principal Investigator:||Jung Hee Koh, MD||Seoul St.Mary's hospital, The Catholic university of Korea|