Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-02-12 @ 6:41 AM
Study NCT ID:
NCT02975960
Status:
COMPLETED
Last Update Posted:
2018-01-25
First Post:
2016-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ADMSCs for the Treatment of Systemic Sclerosis
Sponsor:
The Catholic University of Korea
Organization:
Study Overview
Official Title:
Adipose Tissue-derived Mesenchymal Stem Cells for Cell-based Therapy in the Treatment of Systemic Sclerosis
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: