Early Phase 1 N=20 Treatment

Injection of Autologous Adipose-derived Stromal Vascular Fraction in the Finger of Systemic Sclerosis Patients

Systemic Sclerosis

Bottom Line

View on ClinicalTrials.gov: NCT03060551 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2020

Primary outcome: Primary: Raynaud's Condition Scale — 5; 5; 6.5; 3 score on a scale — p=0.256

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: SVF injection (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Suk-Ho Moon
Primary completion: Dec 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Raynaud's Condition Scale	5; 5; 6.5; 3; 6	0.256
PRIMARY Hand Visual Analogue Scale	5; 4; 5; 4; 5	0.682
PRIMARY Colchin Hand Function Scale	7.5; 14; 16; 18; 17	0.151
PRIMARY Kapandji Score (Ranging 0 to 10) - Dominant Hand	9; 9; 9; 9; 8	0.516
PRIMARY Kapandji Score (Non-dominant Hand)	9; 9; 9; 9; 9	>0.999
PRIMARY Disease-related QOL (Quality of Life) : EuroQol-5 Dimensions Time Trade-off (EQ-5D TTO)	0.807; 0.804; 0.779; 0.801; 0.888	0.034 sig
PRIMARY Disease-related QOL (Quality of Life) : EuroQol Visual Analog Scale (EQ VAS)	70; 68; 70; 80; 80	0.656
PRIMARY Disease-related QOL (Quality of Life) : Health Assessment Questionnaire (HAQ)	1.000; 0.938; 1.000; 0.750; 0.625	0.096
PRIMARY The Degree of Hand Edema (Right)	5.9; 5.9; 6.0; 6.0; 5.9	0.019 sig
PRIMARY The Degree of Hand Edema (Left)	5.9; 5.8; 5.8; 5.9; 5.9	0.050
SECONDARY Changes of Nailfold Capillary Microscopic Findings (Irregularly Enlarged Capillaries)	0.938; 1.313; 1.000; 1.250; 1.125	0.372
SECONDARY Changes of Nailfold Capillary Microscopic Findings (Giant Capillaries)	0.125; 0.000; 0.063; 0.000; 0.125	0.024 sig
SECONDARY Changes of Nailfold Capillary Microscopic Findings (Hemorrhages)	0.000; 0.000; 0.000; 0.000; 0.125	0.188
SECONDARY Changes of Nailfold Capillary Microscopic Findings (Loss of Capillaries)	2.188; 2.063; 2.063; 2.000; 2.250	0.372
SECONDARY Changes of Nailfold Capillary Microscopic Findings (Disorganization of the Vascular Array)	0.688; 0.688; 0.688; 0.875; 0.375	0.633
SECONDARY Changes of Nailfold Capillary Microscopic Findings (Capillary Ramifications)	0.125; 0.125; 0.000; 0.063; 0.125	0.380

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03060551). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.