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ADMSCs for the Treatment of Systemic Sclerosis

NCT02975960 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2018-01-25

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

injection of autologous stromal vascular fraction

1. Acquiring autologous stromal vascular fraction (SVF) from liposuction 2. purifying SVF from lipoaspirates and making syringe filled with SVF 3. SVF injection - Inject SVF on fingers subcutaneously.

Sponsors & Collaborators

  • Seoul St. Mary's Hospital

    collaborator OTHER

  • The Catholic University of Korea

    lead OTHER

Principal Investigators

  • Jung Hee Koh, MD · Seoul St.Mary's hospital, The Catholic university of Korea

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-25
Primary Completion
2017-10-30
Completion
2018-01-20

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02975960 on ClinicalTrials.gov