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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
Sponsor:
Collaborator:
Seoul St. Mary's Hospital
Information provided by (Responsible Party):
Jung Hee Koh, The Catholic University of Korea

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.


Condition or disease Intervention/treatment Phase
Systemic Sclerosis Biological: injection of autologous stromal vascular fraction Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

Arm Intervention/treatment
Experimental: Stromal vascular fraction injection
Injection of autologous stromal vascular fraction on hand.
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.




Primary Outcome Measures :
  1. Change from baseline modified Rodnan Skin score (mRSS) of hands at 12 weeks [ Time Frame: baseline, 12 weeks ]
    Assess hands mRSS


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Locations
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Korea, Republic of
Seoul St. Mary's hospital
Seoul, Korea, Republic of, 06591
Sponsors and Collaborators
The Catholic University of Korea
Seoul St. Mary's Hospital
Investigators
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Principal Investigator: Jung Hee Koh, MD Seoul St.Mary's hospital, The Catholic university of Korea

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Responsible Party: Jung Hee Koh, Clinical Professor, Principal Investigator, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT02975960     History of Changes
Other Study ID Numbers: KC16TISI0343
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jung Hee Koh, The Catholic University of Korea:
systemic sclerosis
adipose derived stem cell
stromal vascular fraction
digital ulcer
gangrene

Additional relevant MeSH terms:
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Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases