Trial Outcomes & Findings for Injection of Autologous Adipose-derived Stromal Vascular Fraction in the Finger of Systemic Sclerosis Patients (NCT NCT03060551)
NCT ID: NCT03060551
Last Updated: 2020-10-08
Results Overview
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)
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Results posted on
2020-10-08
Participant Flow
Between July 2018 and December 2019, a total of twenty subjects were enrolled in this single center, open label, phase I trial.
Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection.
Participant milestones
| Measure |
SVF Injection Group
Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.
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|---|---|
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Overall Study
STARTED
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20
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Overall Study
COMPLETED
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18
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
SVF Injection Group
Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.
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|---|---|
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Overall Study
Withdrawal by Subject
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1
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Overall Study
Adverse Event
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1
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Baseline Characteristics
Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).
Baseline characteristics by cohort
| Measure |
SVF Injection
n=20 Participants
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
SVF injection: 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
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|---|---|
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Age, Continuous
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47 years
n=18 Participants • Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).
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Sex: Female, Male
Female
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15 Participants
n=18 Participants • Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).
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Sex: Female, Male
Male
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3 Participants
n=18 Participants • Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).
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Region of Enrollment
South Korea
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20 participants
n=20 Participants
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Body mass index (BMI) kg/m2
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21.5 kg/m2
n=18 Participants • Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).
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Disease duration (years)
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6 years
n=18 Participants • Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).
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Reynaud's phenomenon duration
|
9 years
n=18 Participants • Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).
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Smoking history (Current or ex-)
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3 Participants
n=18 Participants • Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).
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Interstitial lung disease
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10 Participants
n=18 Participants • Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).
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Types of cutaneous manisfetations (diffuse or limited)
Diffuse
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8 Participants
n=18 Participants • Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).
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Types of cutaneous manisfetations (diffuse or limited)
Limited
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10 Participants
n=18 Participants • Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).
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Hand dominance (right)
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18 Participants
n=18 Participants • Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).
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Pulmonary hypertension
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1 Participants
n=18 Participants • Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).
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History of renal crisis
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1 Participants
n=18 Participants • Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).
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Diabetes mellitus
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0 Participants
n=18 Participants • Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).
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Hypertension
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0 Participants
n=18 Participants • Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).
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Osteoporosis
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6 Participants
n=18 Participants • Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).
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Medication status (calcium channel blocker)
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9 Participants
n=18 Participants • Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).
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Medication status (prostacyclin)
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2 Participants
n=18 Participants • Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).
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Medication status (Aloprostadil)
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3 Participants
n=18 Participants • Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).
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Medication status (Endothelial receptor antagonist))
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1 Participants
n=18 Participants • Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).
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Medication status (Azathioprine)
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5 Participants
n=18 Participants • Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).
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Medication status (Glucocorticoid)
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13 Participants
n=18 Participants • Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).
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Medication status (Methotrexate)
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8 Participants
n=18 Participants • Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).
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Anti-nuclear antibody
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18 Participants
n=18 Participants • Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).
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Anti-centromere antibody
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4 Participants
n=18 Participants • Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).
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Anti-Scl70 antibody
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13 Participants
n=18 Participants • Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).
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Anti-Ro/SSA antibody
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4 Participants
n=18 Participants • Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).
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Anti-U1 RNP antibody
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5 Participants
n=18 Participants • Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).
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PRIMARY outcome
Timeframe: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeksThe 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)
Outcome measures
| Measure |
SVF Injection Group
n=18 Participants
Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.
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|---|---|
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Raynaud's Condition Scale
baseline
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5 score on a scale
Interval 1.8 to 7.3
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Raynaud's Condition Scale
2 weeks
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5 score on a scale
Interval 2.0 to 7.3
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Raynaud's Condition Scale
6 weeks
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6.5 score on a scale
Interval 4.5 to 7.0
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Raynaud's Condition Scale
12 weeks
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3 score on a scale
Interval 2.0 to 5.0
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Raynaud's Condition Scale
24 weeks
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6 score on a scale
Interval 2.0 to 7.5
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PRIMARY outcome
Timeframe: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeksHand pain was assessed using the Hand visual analogue scale (ranging 0 to 10, with higher scores representing more severe pain)
Outcome measures
| Measure |
SVF Injection Group
n=18 Participants
Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.
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|---|---|
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Hand Visual Analogue Scale
baseline
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5 score on a scale
Interval 2.5 to 5.0
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Hand Visual Analogue Scale
2 weeks
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4 score on a scale
Interval 2.0 to 5.0
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Hand Visual Analogue Scale
6 weeks
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5 score on a scale
Interval 3.5 to 6.0
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Hand Visual Analogue Scale
12 weeks
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4 score on a scale
Interval 2.0 to 6.0
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Hand Visual Analogue Scale
24 weeks
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5 score on a scale
Interval 2.5 to 7.0
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PRIMARY outcome
Timeframe: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeksThe Colchin hand function scale (CHFS, ranging 0 to 90, with higher scores representing more deteriorated hand function) scores
Outcome measures
| Measure |
SVF Injection Group
n=18 Participants
Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.
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|---|---|
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Colchin Hand Function Scale
Baseline
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7.5 score on a scale
Interval 3.3 to 21.8
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Colchin Hand Function Scale
2 weeks
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14 score on a scale
Interval 0.0 to 23.3
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Colchin Hand Function Scale
6 weeks
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16 score on a scale
Interval 1.5 to 30.3
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Colchin Hand Function Scale
12 weeks
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18 score on a scale
Interval 1.0 to 27.5
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Colchin Hand Function Scale
24 weeks
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17 score on a scale
Interval 1.5 to 33.0
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PRIMARY outcome
Timeframe: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeksKapandji 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.
Outcome measures
| Measure |
SVF Injection Group
n=18 Participants
Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.
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Kapandji Score (Ranging 0 to 10) - Dominant Hand
Baseline
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9 score on a scale
Interval 8.0 to 9.0
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Kapandji Score (Ranging 0 to 10) - Dominant Hand
2 weeks
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9 score on a scale
Interval 8.0 to 9.0
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Kapandji Score (Ranging 0 to 10) - Dominant Hand
6 weeks
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9 score on a scale
Interval 8.0 to 9.0
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Kapandji Score (Ranging 0 to 10) - Dominant Hand
12 weeks
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9 score on a scale
Interval 8.0 to 9.0
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Kapandji Score (Ranging 0 to 10) - Dominant Hand
24 weeks
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8 score on a scale
Interval 8.0 to 9.0
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PRIMARY outcome
Timeframe: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeksKapandji 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.
Outcome measures
| Measure |
SVF Injection Group
n=18 Participants
Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.
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|---|---|
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Kapandji Score (Non-dominant Hand)
Baseline
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9 score on a scale
Interval 8.0 to 9.0
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Kapandji Score (Non-dominant Hand)
2 weeks
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9 score on a scale
Interval 8.0 to 9.0
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Kapandji Score (Non-dominant Hand)
6 weeks
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9 score on a scale
Interval 8.8 to 9.0
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Kapandji Score (Non-dominant Hand)
12 weeks
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9 score on a scale
Interval 8.0 to 9.0
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Kapandji Score (Non-dominant Hand)
24 weeks
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9 score on a scale
Interval 8.0 to 9.0
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PRIMARY outcome
Timeframe: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeksDisease-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
Outcome measures
| Measure |
SVF Injection Group
n=18 Participants
Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.
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Disease-related QOL (Quality of Life) : EuroQol-5 Dimensions Time Trade-off (EQ-5D TTO)
Baseline
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0.807 score on a scale
Interval 0.709 to 0.88
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Disease-related QOL (Quality of Life) : EuroQol-5 Dimensions Time Trade-off (EQ-5D TTO)
2 weeks
|
0.804 score on a scale
Interval 0.723 to 0.858
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Disease-related QOL (Quality of Life) : EuroQol-5 Dimensions Time Trade-off (EQ-5D TTO)
6 weeks
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0.779 score on a scale
Interval 0.685 to 0.888
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Disease-related QOL (Quality of Life) : EuroQol-5 Dimensions Time Trade-off (EQ-5D TTO)
12 weeks
|
0.801 score on a scale
Interval 0.715 to 0.862
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Disease-related QOL (Quality of Life) : EuroQol-5 Dimensions Time Trade-off (EQ-5D TTO)
24 weeks
|
0.888 score on a scale
Interval 0.71 to 0.93
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PRIMARY outcome
Timeframe: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeksDisease-related QOL (quality of life) : EuroQol visual analog scale (EQ VAS, ranging 0 to 100, with higher scores representing better QOL)
Outcome measures
| Measure |
SVF Injection Group
n=18 Participants
Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.
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|---|---|
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Disease-related QOL (Quality of Life) : EuroQol Visual Analog Scale (EQ VAS)
Baseline
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70 score on a scale
Interval 50.0 to 81.0
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Disease-related QOL (Quality of Life) : EuroQol Visual Analog Scale (EQ VAS)
2 weeks
|
68 score on a scale
Interval 50.0 to 80.0
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Disease-related QOL (Quality of Life) : EuroQol Visual Analog Scale (EQ VAS)
6 weeks
|
70 score on a scale
Interval 50.0 to 75.0
|
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Disease-related QOL (Quality of Life) : EuroQol Visual Analog Scale (EQ VAS)
12 weeks
|
80 score on a scale
Interval 70.0 to 88.0
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Disease-related QOL (Quality of Life) : EuroQol Visual Analog Scale (EQ VAS)
24 weeks
|
80 score on a scale
Interval 55.0 to 83.0
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PRIMARY outcome
Timeframe: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeksDisease-related QOL (quality of life) : health assessment questionnaire (HAQ, ranging 0 to 3, with higher scores meaning lower QOL)
Outcome measures
| Measure |
SVF Injection Group
n=18 Participants
Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.
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|---|---|
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Disease-related QOL (Quality of Life) : Health Assessment Questionnaire (HAQ)
24 weeks
|
0.625 score on a scale
Interval 0.188 to 1.313
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Disease-related QOL (Quality of Life) : Health Assessment Questionnaire (HAQ)
Baseline
|
1.000 score on a scale
Interval 0.219 to 1.406
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Disease-related QOL (Quality of Life) : Health Assessment Questionnaire (HAQ)
2 weeks
|
0.938 score on a scale
Interval 0.219 to 1.375
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Disease-related QOL (Quality of Life) : Health Assessment Questionnaire (HAQ)
6 weeks
|
1.000 score on a scale
Interval 0.0 to 1.563
|
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Disease-related QOL (Quality of Life) : Health Assessment Questionnaire (HAQ)
12 weeks
|
0.750 score on a scale
Interval 0.063 to 1.438
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PRIMARY outcome
Timeframe: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeksThe 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
Outcome measures
| Measure |
SVF Injection Group
n=18 Participants
Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.
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|---|---|
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The Degree of Hand Edema (Right)
Baseline
|
5.9 cm
Interval 5.7 to 6.4
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The Degree of Hand Edema (Right)
2 weeks
|
5.9 cm
Interval 5.5 to 6.4
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The Degree of Hand Edema (Right)
6 weeks
|
6.0 cm
Interval 5.6 to 6.3
|
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The Degree of Hand Edema (Right)
12 weeks
|
6.0 cm
Interval 5.7 to 6.4
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The Degree of Hand Edema (Right)
24 weeks
|
5.9 cm
Interval 5.7 to 6.3
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PRIMARY outcome
Timeframe: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeksThe 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
Outcome measures
| Measure |
SVF Injection Group
n=18 Participants
Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.
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|---|---|
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The Degree of Hand Edema (Left)
Baseline
|
5.9 cm
Interval 5.6 to 6.2
|
|
The Degree of Hand Edema (Left)
2 weeks
|
5.8 cm
Interval 5.5 to 6.3
|
|
The Degree of Hand Edema (Left)
6 weeks
|
5.8 cm
Interval 5.5 to 6.3
|
|
The Degree of Hand Edema (Left)
12 weeks
|
5.9 cm
Interval 5.6 to 6.2
|
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The Degree of Hand Edema (Left)
24 weeks
|
5.9 cm
Interval 5.6 to 6.3
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SECONDARY outcome
Timeframe: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeksIn 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.
Outcome measures
| Measure |
SVF Injection Group
n=18 Participants
Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.
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|---|---|
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Changes of Nailfold Capillary Microscopic Findings (Irregularly Enlarged Capillaries)
Baseline
|
0.938 score on a scale
Interval 0.594 to 1.969
|
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Changes of Nailfold Capillary Microscopic Findings (Irregularly Enlarged Capillaries)
2 weeks
|
1.313 score on a scale
Interval 0.469 to 1.813
|
|
Changes of Nailfold Capillary Microscopic Findings (Irregularly Enlarged Capillaries)
6 weeks
|
1.000 score on a scale
Interval 0.5 to 1.813
|
|
Changes of Nailfold Capillary Microscopic Findings (Irregularly Enlarged Capillaries)
12 weeks
|
1.250 score on a scale
Interval 0.75 to 1.625
|
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Changes of Nailfold Capillary Microscopic Findings (Irregularly Enlarged Capillaries)
24 weeks
|
1.125 score on a scale
Interval 0.688 to 1.563
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeksIn 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.
Outcome measures
| Measure |
SVF Injection Group
n=18 Participants
Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.
|
|---|---|
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Changes of Nailfold Capillary Microscopic Findings (Giant Capillaries)
Baseline
|
0.125 score on a scale
Interval 0.0 to 1.375
|
|
Changes of Nailfold Capillary Microscopic Findings (Giant Capillaries)
2 weeks
|
0.000 score on a scale
Interval 0.0 to 0.656
|
|
Changes of Nailfold Capillary Microscopic Findings (Giant Capillaries)
6 weeks
|
0.063 score on a scale
Interval 0.0 to 0.688
|
|
Changes of Nailfold Capillary Microscopic Findings (Giant Capillaries)
12 weeks
|
0.000 score on a scale
Interval 0.0 to 0.625
|
|
Changes of Nailfold Capillary Microscopic Findings (Giant Capillaries)
24 weeks
|
0.125 score on a scale
Interval 0.0 to 0.313
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeksIn 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.
Outcome measures
| Measure |
SVF Injection Group
n=18 Participants
Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.
|
|---|---|
|
Changes of Nailfold Capillary Microscopic Findings (Hemorrhages)
Baseline
|
0.000 score on a scale
Interval 0.0 to 0.125
|
|
Changes of Nailfold Capillary Microscopic Findings (Hemorrhages)
2 weeks
|
0.000 score on a scale
Interval 0.0 to 0.063
|
|
Changes of Nailfold Capillary Microscopic Findings (Hemorrhages)
6 weeks
|
0.000 score on a scale
Interval 0.0 to 0.094
|
|
Changes of Nailfold Capillary Microscopic Findings (Hemorrhages)
12 weeks
|
0.000 score on a scale
Interval 0.0 to 0.188
|
|
Changes of Nailfold Capillary Microscopic Findings (Hemorrhages)
24 weeks
|
0.125 score on a scale
Interval 0.0 to 0.313
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeksIn 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.
Outcome measures
| Measure |
SVF Injection Group
n=18 Participants
Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.
|
|---|---|
|
Changes of Nailfold Capillary Microscopic Findings (Loss of Capillaries)
Baseline
|
2.188 score on a scale
Interval 1.469 to 2.406
|
|
Changes of Nailfold Capillary Microscopic Findings (Loss of Capillaries)
2 weeks
|
2.063 score on a scale
Interval 1.438 to 2.5
|
|
Changes of Nailfold Capillary Microscopic Findings (Loss of Capillaries)
6 weeks
|
2.063 score on a scale
Interval 1.625 to 2.344
|
|
Changes of Nailfold Capillary Microscopic Findings (Loss of Capillaries)
12 weeks
|
2.000 score on a scale
Interval 1.438 to 2.563
|
|
Changes of Nailfold Capillary Microscopic Findings (Loss of Capillaries)
24 weeks
|
2.250 score on a scale
Interval 1.313 to 2.563
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeksIn 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.
Outcome measures
| Measure |
SVF Injection Group
n=18 Participants
Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.
|
|---|---|
|
Changes of Nailfold Capillary Microscopic Findings (Disorganization of the Vascular Array)
Baseline
|
0.688 score on a scale
Interval 0.188 to 1.625
|
|
Changes of Nailfold Capillary Microscopic Findings (Disorganization of the Vascular Array)
2 weeks
|
0.688 score on a scale
Interval 0.563 to 1.906
|
|
Changes of Nailfold Capillary Microscopic Findings (Disorganization of the Vascular Array)
6 weeks
|
0.688 score on a scale
Interval 0.0 to 1.688
|
|
Changes of Nailfold Capillary Microscopic Findings (Disorganization of the Vascular Array)
12 weeks
|
0.875 score on a scale
Interval 0.0 to 1.875
|
|
Changes of Nailfold Capillary Microscopic Findings (Disorganization of the Vascular Array)
24 weeks
|
0.375 score on a scale
Interval 0.0 to 1.938
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeksIn 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.
Outcome measures
| Measure |
SVF Injection Group
n=18 Participants
Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.
|
|---|---|
|
Changes of Nailfold Capillary Microscopic Findings (Capillary Ramifications)
Baseline
|
0.125 score on a scale
Interval 0.0 to 0.375
|
|
Changes of Nailfold Capillary Microscopic Findings (Capillary Ramifications)
2 weeks
|
0.125 score on a scale
Interval 0.0 to 0.438
|
|
Changes of Nailfold Capillary Microscopic Findings (Capillary Ramifications)
6 weeks
|
0.000 score on a scale
Interval 0.0 to 1.688
|
|
Changes of Nailfold Capillary Microscopic Findings (Capillary Ramifications)
12 weeks
|
0.063 score on a scale
Interval 0.0 to 0.594
|
|
Changes of Nailfold Capillary Microscopic Findings (Capillary Ramifications)
24 weeks
|
0.125 score on a scale
Interval 0.0 to 0.375
|
Adverse Events
SVF Injection Group
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SVF Injection Group
n=20 participants at risk
Participants received SVF treatment. All patients were regulary assessed at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.
|
|---|---|
|
Injury, poisoning and procedural complications
Transient paresthesia in liposuction lesions
|
5.0%
1/20 • Number of events 1 • Up to 24 weeks
No serious adverse events occurred throughout study.
|
|
Injury, poisoning and procedural complications
Dizziness after lidocaine injection
|
5.0%
1/20 • Number of events 1 • Up to 24 weeks
No serious adverse events occurred throughout study.
|
|
Injury, poisoning and procedural complications
Transient pallor in finger after injection
|
15.0%
3/20 • Number of events 3 • Up to 24 weeks
No serious adverse events occurred throughout study.
|
Additional Information
Suk-Ho Moon
Department of Plastic Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea
Phone: 821090803527
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place