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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
SVF is increasingly recognised as an easily accessible source of regenerative cells with therapeutic potential in ischaemic or autoimmune disease. We aimed to measure for the first time the safety, tolerability and potential efficacy of autologous SVF cells local injections in patients with systemic sclerosis
Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea
Seoul, South Korea
Raynaud's Condition Scale
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)
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Hand Visual Analogue Scale
Hand pain was assessed using the Hand visual analogue scale (ranging 0 to 10, with higher scores representing more severe pain)
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Colchin Hand Function Scale
The Colchin hand function scale (CHFS, ranging 0 to 90, with higher scores representing more deteriorated hand function) scores
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Kapandji Score (Ranging 0 to 10) - Dominant Hand
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.
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Kapandji Score (Non-dominant Hand)
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.
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Disease-related QOL (Quality of Life) : EuroQol-5 Dimensions Time Trade-off (EQ-5D TTO)
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Disease-related QOL (Quality of Life) : EuroQol Visual Analog Scale (EQ VAS)
Disease-related QOL (quality of life) : EuroQol visual analog scale (EQ VAS, ranging 0 to 100, with higher scores representing better QOL)
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Disease-related QOL (Quality of Life) : Health Assessment Questionnaire (HAQ)
Disease-related QOL (quality of life) : health assessment questionnaire (HAQ, ranging 0 to 3, with higher scores meaning lower QOL)
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
The Degree of Hand Edema (Right)
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
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
The Degree of Hand Edema (Left)
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
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Changes of Nailfold Capillary Microscopic Findings (Irregularly Enlarged Capillaries)
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.
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Changes of Nailfold Capillary Microscopic Findings (Giant Capillaries)
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.
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Changes of Nailfold Capillary Microscopic Findings (Hemorrhages)
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.
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Changes of Nailfold Capillary Microscopic Findings (Loss of Capillaries)
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.
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Changes of Nailfold Capillary Microscopic Findings (Disorganization of the Vascular Array)
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.
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Changes of Nailfold Capillary Microscopic Findings (Capillary Ramifications)
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.
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks