Clinical trial NCT03060551: Injection of Autologous Adipose-derived Stromal Vascular Fraction in the Finger of Systemic Sclerosis Patients
Official title: Safety, Tolerability and Potential Efficacy of Injection of Autologous Adipose-derived Stromal Vascular Fraction in the Finger of Systemic Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Systemic Sclerosis
Keywords: stromal vascular fraction
hand disability
mesenchymal stem cells
phase I trial
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Systemic sclerosis patients with hand disability, planning 24 weeks of follow-up period Autologous adipose tissue-derived stromal vascular fraction(SVF) injected into the subcutaneous tissue of each finger in contact with neurovascular pedicles.
Primary purpose: TREATMENT

Brief summary: This study outlines the safety of the autologous SVF cells injection in the hands of patients with SSc. Preliminary assessments at 6 months will suggest potential efficacy needing confirmation in a randomised placebo-controlled trial on a larger population

Detailed description: In patients with systemic sclerosis(scleroderma, SSc), impaired hand function greatly contributes to disability and reduced quality of life, and is insufficiently relived by currently available therapies. Adipose tissue-derived stromal vascular fraction (SVF) is increasingly recognized as an easily accessible source of regenerative cells with therapeutic potential in ischaemic or autoimmune disease. The investigators aimed to measure for the first time the safety, tolerability, and potential efficacy of autologous SVF cells local injections in patients with SSc with hand disability.

Eligibility criteria: Inclusion Criteria:

* age over 18 year old
* Cochin Hand Function Scale (CHFS) \> 20/90

Exclusion Criteria:

* new vasodilators or immunosuppressive therapy for SSc in the 3 months prior to enrolment
* new vasodilators or immunosuppressive therapy for SSc during the 6-month follow-up
* clinical or radiological signs of digital infection
* positive status for HIV
* positive status for hepatitis B or C
* positive status for human T-cell leukemia virus 1-2
* positive status for syphilis
* pregnancy
* BMI less than 17kg/m2

Primary outcomes:
measure: Raynaud's Condition Scale
timeFrame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
measure: Hand Visual Analogue Scale
timeFrame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
measure: Colchin Hand Function Scale
timeFrame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
measure: Kapandji Score (Ranging 0 to 10) - Dominant Hand
timeFrame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
measure: Kapandji Score (Non-dominant Hand)
timeFrame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
measure: Disease-related QOL (Quality of Life) : EuroQol-5 Dimensions Time Trade-off (EQ-5D TTO)
timeFrame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
measure: Disease-related QOL (Quality of Life) : EuroQol Visual Analog Scale (EQ VAS)
timeFrame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
measure: Disease-related QOL (Quality of Life) : Health Assessment Questionnaire (HAQ)
timeFrame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
measure: The Degree of Hand Edema (Right)
timeFrame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
measure: The Degree of Hand Edema (Left)
timeFrame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Secondary outcomes:
measure: Changes of Nailfold Capillary Microscopic Findings (Irregularly Enlarged Capillaries)
timeFrame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
measure: Changes of Nailfold Capillary Microscopic Findings (Giant Capillaries)
timeFrame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
measure: Changes of Nailfold Capillary Microscopic Findings (Hemorrhages)
timeFrame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
measure: Changes of Nailfold Capillary Microscopic Findings (Loss of Capillaries)
timeFrame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
measure: Changes of Nailfold Capillary Microscopic Findings (Disorganization of the Vascular Array)
timeFrame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
measure: Changes of Nailfold Capillary Microscopic Findings (Capillary Ramifications)
timeFrame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Suk-Ho Moon, MD, PhD
role: STUDY_DIRECTOR
affiliation: Seoul St. Mary's Hospital
name: Seung-Ki Kwok
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park Y, Lee YJ, Koh JH, Lee J, Min HK, Kim MY, Kim KJ, Lee SJ, Rhie JW, Kim WU, Park SH, Moon SH, Kwok SK. Clinical Efficacy and Safety of Injection of Stromal Vascular Fraction Derived from Autologous Adipose Tissues in Systemic Sclerosis Patients with Hand Disability: A Proof-Of-Concept Trial. J Clin Med. 2020 Sep 19;9(9):3023. doi: 10.3390/jcm9093023.