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

Early Phase 1

Completed

Conditions: Systemic Sclerosis

Interventions: Procedure: SVF injection

Registration Number: NCT03060551

Lead Sponsor: Suk-Ho Moon

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SVF injection	SVF injection	SVF was obtained from lipoaspirates, using an automated processing system, and subsequently injected into the subcutaneous tissue of each finger in contact with neurovascular pedicles

Primary Outcome Measures

Name	Time	Method
Colchin Hand Function Scale	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks	The Colchin hand function scale (CHFS, ranging 0 to 90, with higher scores representing more deteriorated hand function) scores
The Degree of Hand Edema (Right)	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks	The finger circumferences of the second to the fifth fingers measured in the middle portion of each proximal phalanx were used to assess the degree of hand edema
The Degree of Hand Edema (Left)	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks	The finger circumferences of the second to the fifth fingers measured in the middle portion of each proximal phalanx were used to assess the degree of hand edema
Kapandji Score (Ranging 0 to 10) - Dominant Hand	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks	Kapandji score (ranging 0 to 10) is validated measures in past studies as outcomes for hand disability. The Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb. A score of 0 indicates no opposition, a score of 10 indicates maximal opposition.
Kapandji Score (Non-dominant Hand)	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks	Kapandji score (ranging 0 to 10) is validated measures in past studies as outcomes for hand disability. The Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb. A score of 0 indicates no opposition, a score of 10 indicates maximal opposition.
Disease-related QOL (Quality of Life) : EuroQol-5 Dimensions Time Trade-off (EQ-5D TTO)	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks	Disease-related QOL (quality of life) was measured by EuroQol-5 dimensions time trade-off (EQ-5D TTO, ranging 0 to 1, with higher values representing better QOL) values
Disease-related QOL (Quality of Life) : EuroQol Visual Analog Scale (EQ VAS)	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks	Disease-related QOL (quality of life) : EuroQol visual analog scale (EQ VAS, ranging 0 to 100, with higher scores representing better QOL)
Raynaud's Condition Scale	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks	The severity of Raynaud's phenomenon was assessed using the Raynaud's condition scale (ranging 0 to 10, with higher scores representing more severe Raynaud's phenomenon)
Hand Visual Analogue Scale	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks	Hand pain was assessed using the Hand visual analogue scale (ranging 0 to 10, with higher scores representing more severe pain)
Disease-related QOL (Quality of Life) : Health Assessment Questionnaire (HAQ)	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks	Disease-related QOL (quality of life) : health assessment questionnaire (HAQ, ranging 0 to 3, with higher scores meaning lower QOL)

Secondary Outcome Measures

Name	Time	Method
Changes of Nailfold Capillary Microscopic Findings (Hemorrhages)	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks	In order to assess the severity of microangiopathies in both fingers, a semiquantitative scoring system for nailfold capillary microscopic findings was adopted. A total of six parameters (irregularly enlarged capillaries, giant capillaries, hemorrhages, loss of capillaries, disorganization of the vascular array and capillary ramifications) were measured using the semiquantitative manner on the scale ranging 0 to 3, indicating more severe as scores were higher. Each parameter was scored for four fingers of both hands, except thumbs, and the median score value of each parameter in both hands was finally presented.
Changes of Nailfold Capillary Microscopic Findings (Disorganization of the Vascular Array)	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks	In order to assess the severity of microangiopathies in both fingers, a semiquantitative scoring system for nailfold capillary microscopic findings was adopted. A total of six parameters (irregularly enlarged capillaries, giant capillaries, hemorrhages, loss of capillaries, disorganization of the vascular array and capillary ramifications) were measured using the semiquantitative manner on the scale ranging 0 to 3, indicating more severe as scores were higher. Each parameter was scored for four fingers of both hands, except thumbs, and the median score value of each parameter in both hands was finally presented.
Changes of Nailfold Capillary Microscopic Findings (Irregularly Enlarged Capillaries)	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks	In order to assess the severity of microangiopathies in both fingers, a semiquantitative scoring system for nailfold capillary microscopic findings was adopted. A total of six parameters (irregularly enlarged capillaries, giant capillaries, hemorrhages, loss of capillaries, disorganization of the vascular array and capillary ramifications) were measured using the semiquantitative manner on the scale ranging 0 to 3, indicating more severe as scores were higher. Each parameter was scored for four fingers of both hands, except thumbs, and the median score value of each parameter in both hands was finally presented.
Changes of Nailfold Capillary Microscopic Findings (Giant Capillaries)	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks	In order to assess the severity of microangiopathies in both fingers, a semiquantitative scoring system for nailfold capillary microscopic findings was adopted. A total of six parameters (irregularly enlarged capillaries, giant capillaries, hemorrhages, loss of capillaries, disorganization of the vascular array and capillary ramifications) were measured using the semiquantitative manner on the scale ranging 0 to 3, indicating more severe as scores were higher. Each parameter was scored for four fingers of both hands, except thumbs, and the median score value of each parameter in both hands was finally presented.
Changes of Nailfold Capillary Microscopic Findings (Loss of Capillaries)	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks	In order to assess the severity of microangiopathies in both fingers, a semiquantitative scoring system for nailfold capillary microscopic findings was adopted. A total of six parameters (irregularly enlarged capillaries, giant capillaries, hemorrhages, loss of capillaries, disorganization of the vascular array and capillary ramifications) were measured using the semiquantitative manner on the scale ranging 0 to 3, indicating more severe as scores were higher. Each parameter was scored for four fingers of both hands, except thumbs, and the median score value of each parameter in both hands was finally presented.
Changes of Nailfold Capillary Microscopic Findings (Capillary Ramifications)	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks	In order to assess the severity of microangiopathies in both fingers, a semiquantitative scoring system for nailfold capillary microscopic findings was adopted. A total of six parameters (irregularly enlarged capillaries, giant capillaries, hemorrhages, loss of capillaries, disorganization of the vascular array and capillary ramifications) were measured using the semiquantitative manner on the scale ranging 0 to 3, indicating more severe as scores were higher. Each parameter was scored for four fingers of both hands, except thumbs, and the median score value of each parameter in both hands was finally presented.