Systemic SclerosisNCT02975960
ADMSCs for the Treatment of Systemic Sclerosis
A study testing injection of autologous stromal vascular fraction in people with Systemic Sclerosis, run by The Catholic University of Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- injection of autologous stromal vascular fraction
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Oct 2016to 20 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the detailed description
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
- Conditions
- Systemic Sclerosis
- Being tested
- injection of autologous stromal vascular fraction
- Keywords
- systemic sclerosis, adipose derived stem cell, stromal vascular fraction, digital ulcer, gangrene
- Medical subject headings
- Scleroderma, Systemic, digital ulcers, Gangrene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection of autologous stromal vascular fractionBiological
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Stromal vascular fraction injection | Experimental | Injection of autologous stromal vascular fraction on hand. Receives: Biological: injection of autologous stromal vascular fraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline modified Rodnan Skin score (mRSS) of hands at 12 weeks
Assess hands mRSS
Measured: baseline, 12 weeks
Secondary outcomes (8)
Change from baseline Raynaud's condition score at 12 weeks
The severity (frequency and intensity of crises) of Raynaud's phenomenon
Measured: baseline, 12 weeks
Change from baseline Visual Analog Score for pain the hands at 12 weeks
Patient report hand pain degree, comparing baseline and 12 weeks
Measured: baseline, 12 weeks
Changes from baseline mRSS (total) at 12 weeks
Assess total mRSS (including hands)
Measured: baseline, 12 weeks
Change from baseline Kapandji score at 12weeks
assess the mobility of both hands
Measured: baseline, 12 weeks
Change from baseline Cochin hand function scale at 12 weeks
Assess hand function (patients reported outcome)
Measured: baseline, 12 weeks
Change from baseline Systemic sclerosis HAQ at 12 weeks
he quality of life- score adapted to systemic sclerosis
Measured: baseline, 12 weeks
Change from baseline peripheral vasculature at 12 weeks
Assess peripheral vascularity by Nailfold capillaroscopy
Measured: baseline, 12 weeks
Change from baseline finger circumference at 12 weeks
Measure second to fifth finger circumference
Measured: baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study start25 Oct 2016
- Primary completion30 Oct 2017
- Study completion20 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul St. Mary's Hospital
- Responsible party
- Principal investigator, Jung Hee Koh, The Catholic University of Korea
- Investigators
- Jung Hee Koh, MD, Principal investigator, Seoul St. Mary's Hospital, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975960
- Sponsor's protocol ID
- KC16TISI0343
- Status last verified
- Jan 2018
- First submitted
- 9 Nov 2016
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose Tissue-derived Mesenchymal Stem Cells for Cell-based Therapy in the Treatment of Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT02975960
- Acronym / sponsor ID
- KC16TISI0343
- Conditions
- Systemic Sclerosis
- Keywords
- systemic sclerosis, adipose derived stem cell, stromal vascular fraction, digital ulcer, gangrene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Collaborators
- Seoul St. Mary's Hospital
- Study start
- 25 Oct 2016 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 20 Jan 2018 (actual)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stromal vascular fraction injection | Experimental | Biological: injection of autologous stromal vascular fractionInjection of autologous stromal vascular fraction on hand. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- Pregnancy
- Start new medications within 3 months prior to enrollment
- Previous sympathectomy or amputation
- Current systemic infection
- AIDS, Syphilis, hepatitis B\&C
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| injection of autologous stromal vascular fraction1. 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. | Biological | Stromal vascular fraction injection |
Primary outcome
Change from baseline modified Rodnan Skin score (mRSS) of hands at 12 weeks
Time frame: baseline, 12 weeks
Assess hands mRSS
8 secondary outcomes
Change from baseline Raynaud's condition score at 12 weeks
Time frame: baseline, 12 weeks
Change from baseline Visual Analog Score for pain the hands at 12 weeks
Time frame: baseline, 12 weeks
Changes from baseline mRSS (total) at 12 weeks
Time frame: baseline, 12 weeks
Change from baseline Kapandji score at 12weeks
Time frame: baseline, 12 weeks
Change from baseline Cochin hand function scale at 12 weeks
Time frame: baseline, 12 weeks
Change from baseline Systemic sclerosis HAQ at 12 weeks
Time frame: baseline, 12 weeks
Change from baseline peripheral vasculature at 12 weeks
Time frame: baseline, 12 weeks
Change from baseline finger circumference at 12 weeks
Time frame: baseline, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung Hee Koh, MD principal investigator
Seoul St. Mary's Hospital, The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing injection of autologous stromal vascular fraction in people with Systemic Sclerosis, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline modified Rodnan Skin score (mRSS) of hands at 12 weeks (time frame: baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.