NCT02975960

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2018

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

1 year

First QC Date

November 9, 2016

Last Update Submit

January 23, 2018

Conditions

Systemic Sclerosis

Keywords

systemic sclerosisadipose derived stem cellstromal vascular fractiondigital ulcergangrene

Outcome Measures

Primary Outcomes (1)

  • Change from baseline modified Rodnan Skin score (mRSS) of hands at 12 weeks

    Assess hands mRSS

    baseline, 12 weeks

Secondary Outcomes (8)

  • Change from baseline Raynaud's condition score at 12 weeks

    baseline, 12 weeks

  • Change from baseline Visual Analog Score for pain the hands at 12 weeks

    baseline, 12 weeks

  • Changes from baseline mRSS (total) at 12 weeks

    baseline, 12 weeks

  • Change from baseline Kapandji score at 12weeks

    baseline, 12 weeks

  • Change from baseline Cochin hand function scale at 12 weeks

    baseline, 12 weeks

  • +3 more secondary outcomes

Study Arms (1)

Stromal vascular fraction injection

EXPERIMENTAL

Injection of autologous stromal vascular fraction on hand.

Biological: injection of autologous stromal vascular fraction

Interventions

injection of autologous stromal vascular fractionBIOLOGICAL

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.

Stromal vascular fraction injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St. Mary's hospital

Seoul, 06591, South Korea

Location

MeSH Terms

Conditions

Scleroderma, Systemicdigital ulcersGangrene

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jung Hee Koh, MD

    Seoul St.Mary's hospital, The Catholic university of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor, Principal Investigator

Study Record Dates

First Submitted

November 9, 2016

First Posted

November 29, 2016

Study Start

October 25, 2016

Primary Completion

October 30, 2017

Study Completion

January 20, 2018

Last Updated

January 25, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)