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Completed

NCT Number: NCT02975960

ADMSCs for the Treatment of Systemic Sclerosis

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.

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Key information

Conditions

Systemic Sclerosis Connective Tissue Diseases Gangrene Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases digital ulcers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul St. Mary's hospital

Seoul, 06591, South Korea

About this study

In this study, the investigators will inject autologous Stromal vascular fraction.

  • Acquiring autologous stromal vascular fraction by plastic surgeon
  • Liposuction
  • Extraction and purifying SVF using Smart-X system (15-20 min)
  • Making syringe filled with autologous SVF
  • SVF injection

Inject SVF subcutaneously with 25G needle in finger

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

injection of autologous stromal vascular fraction

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

Primary outcomes

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

    Time frame: baseline, 12 weeks

    Assess hands mRSS

Secondary outcomes

  1. 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

  2. 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

  3. Changes from baseline mRSS (total) at 12 weeks

    Time frame: baseline, 12 weeks

    Assess total mRSS (including hands)

  4. Change from baseline Kapandji score at 12weeks

    Time frame: baseline, 12 weeks

    assess the mobility of both hands

  5. Change from baseline Cochin hand function scale at 12 weeks

    Time frame: baseline, 12 weeks

    Assess hand function (patients reported outcome)

  6. Change from baseline Systemic sclerosis HAQ at 12 weeks

    Time frame: baseline, 12 weeks

    he quality of life- score adapted to systemic sclerosis

  7. Change from baseline peripheral vasculature at 12 weeks

    Time frame: baseline, 12 weeks

    Assess peripheral vascularity by Nailfold capillaroscopy

  8. Change from baseline finger circumference at 12 weeks

    Time frame: baseline, 12 weeks

    Measure second to fifth finger circumference

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Collaborators

  • Seoul St. Mary's Hospital

Registry information

Official study title

Adipose Tissue-derived Mesenchymal Stem Cells for Cell-based Therapy in the Treatment of Systemic Sclerosis

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Nov 29, 2016
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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