ADMSCs for the Treatment of Systemic Sclerosis
Adipose Tissue-derived Mesenchymal Stem Cells for Cell-based Therapy in 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
In this study, the investigators will inject autologous Stromal vascular fraction.
1) 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
2) SVF injection
Inject SVF subcutaneously with 25G needle in finger
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Seoul, Korea, Republikken, 06591
- Seoul st. mary's hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Stromal vascular fraction injection
Injection of autologous stromal vascular fraction on hand.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change from baseline modified Rodnan Skin score (mRSS) of hands at 12 weeks
Tidsramme: baseline, 12 weeks
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Assess hands mRSS
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baseline, 12 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline Raynaud's condition score at 12 weeks
Tidsramme: baseline, 12 weeks
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The severity (frequency and intensity of crises) of Raynaud's phenomenon
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baseline, 12 weeks
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Change from baseline Visual Analog Score for pain the hands at 12 weeks
Tidsramme: baseline, 12 weeks
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Patient report hand pain degree, comparing baseline and 12 weeks
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baseline, 12 weeks
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Changes from baseline mRSS (total) at 12 weeks
Tidsramme: baseline, 12 weeks
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Assess total mRSS (including hands)
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baseline, 12 weeks
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Change from baseline Kapandji score at 12weeks
Tidsramme: baseline, 12 weeks
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assess the mobility of both hands
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baseline, 12 weeks
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Change from baseline Cochin hand function scale at 12 weeks
Tidsramme: baseline, 12 weeks
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Assess hand function (patients reported outcome)
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baseline, 12 weeks
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Change from baseline Systemic sclerosis HAQ at 12 weeks
Tidsramme: baseline, 12 weeks
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he quality of life- score adapted to systemic sclerosis
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baseline, 12 weeks
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Change from baseline peripheral vasculature at 12 weeks
Tidsramme: baseline, 12 weeks
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Assess peripheral vascularity by Nailfold capillaroscopy
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baseline, 12 weeks
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Change from baseline finger circumference at 12 weeks
Tidsramme: baseline, 12 weeks
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Measure second to fifth finger circumference
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baseline, 12 weeks
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jung Hee Koh, MD, Seoul St.Mary's hospital, The Catholic university of Korea
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KC16TISI0343
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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