An Early Phase 1 interventional study of SVF injection in Systemic Sclerosis, sponsored by Suk-Ho Moon. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-08.
Sponsored by Suk-Ho Moon · Early Phase 1, Interventional, and Treatment
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.
688 studies on the registry are indexed under Scleroderma, Systemic; 223 are open to participants now.
This study's enrollment of 20 is below the median of 34 across 493 interventional studies indexed under Scleroderma, Systemic.
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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
Procedure: 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
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
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
Between July 2018 and December 2019, a total of twenty subjects were enrolled in this single center, open label, phase I trial.
| Milestone | SVF Injection Group |
|---|---|
| Started | 20 |
| Completed | 18 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Adverse event | 1 |
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)
| score on a scale | SVF Injection Group |
|---|---|
| baseline | 5 (1.8 to 7.3) |
| 2 weeks | 5 (2 to 7.3) |
| 6 weeks | 6.5 (4.5 to 7.0) |
| 12 weeks | 3 (2 to 5) |
| 24 weeks | 6 (2 to 7.5) |
Hand pain was assessed using the Hand visual analogue scale (ranging 0 to 10, with higher scores representing more severe pain)
| score on a scale | SVF Injection Group |
|---|---|
| baseline | 5 (2.5 to 5) |
| 2 weeks | 4 (2 to 5) |
| 6 weeks | 5 (3.5 to 6) |
| 12 weeks | 4 (2 to 6) |
| 24 weeks | 5 (2.5 to 7) |
The Colchin hand function scale (CHFS, ranging 0 to 90, with higher scores representing more deteriorated hand function) scores
| score on a scale | SVF Injection Group |
|---|---|
| Baseline | 7.5 (3.3 to 21.8) |
| 2 weeks | 14 (0 to 23.3) |
| 6 weeks | 16 (1.5 to 30.3) |
| 12 weeks | 18 (1 to 27.5) |
| 24 weeks | 17 (1.5 to 33) |
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.
| score on a scale | SVF Injection Group |
|---|---|
| Baseline | 9 (8 to 9) |
| 2 weeks | 9 (8 to 9) |
| 6 weeks | 9 (8 to 9) |
| 12 weeks | 9 (8 to 9) |
| 24 weeks | 8 (8 to 9) |
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.
| score on a scale | SVF Injection Group |
|---|---|
| Baseline | 9 (8 to 9) |
| 2 weeks | 9 (8 to 9) |
| 6 weeks | 9 (8.8 to 9) |
| 12 weeks | 9 (8 to 9) |
| 24 weeks | 9 (8 to 9) |
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
| score on a scale | SVF Injection Group |
|---|---|
| Baseline | 0.807 (0.709 to 0.880) |
| 2 weeks | 0.804 (0.723 to 0.858) |
| 6 weeks | 0.779 (0.685 to 0.888) |
| 12 weeks | 0.801 (0.715 to 0.862) |
| 24 weeks | 0.888 (0.710 to 0.930) |
Disease-related QOL (quality of life) : EuroQol visual analog scale (EQ VAS, ranging 0 to 100, with higher scores representing better QOL)
| score on a scale | SVF Injection Group |
|---|---|
| Baseline | 70 (50 to 81) |
| 2 weeks | 68 (50 to 80) |
| 6 weeks | 70 (50 to 75) |
| 12 weeks | 80 (70 to 88) |
| 24 weeks | 80 (55 to 83) |
Disease-related QOL (quality of life) : health assessment questionnaire (HAQ, ranging 0 to 3, with higher scores meaning lower QOL)
| score on a scale | SVF Injection Group |
|---|---|
| Baseline | 1.000 (0.219 to 1.406) |
| 2 weeks | 0.938 (0.219 to 1.375) |
| 6 weeks | 1.000 (0.000 to 1.563) |
| 12 weeks | 0.750 (0.063 to 1.438) |
| 24 weeks | 0.625 (0.188 to 1.313) |
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
| cm | SVF Injection Group |
|---|---|
| Baseline | 5.9 (5.7 to 6.4) |
| 2 weeks | 5.9 (5.5 to 6.4) |
| 6 weeks | 6.0 (5.6 to 6.3) |
| 12 weeks | 6.0 (5.7 to 6.4) |
| 24 weeks | 5.9 (5.7 to 6.3) |
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
| cm | SVF Injection Group |
|---|---|
| Baseline | 5.9 (5.6 to 6.2) |
| 2 weeks | 5.8 (5.5 to 6.3) |
| 6 weeks | 5.8 (5.5 to 6.3) |
| 12 weeks | 5.9 (5.6 to 6.2) |
| 24 weeks | 5.9 (5.6 to 6.3) |
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.
| score on a scale | SVF Injection Group |
|---|---|
| Baseline | 0.938 (0.594 to 1.969) |
| 2 weeks | 1.313 (0.469 to 1.813) |
| 6 weeks | 1.000 (0.5000 to 1.813) |
| 12 weeks | 1.250 (0.750 to 1.625) |
| 24 weeks | 1.125 (0.688 to 1.563) |
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.
| score on a scale | SVF Injection Group |
|---|---|
| Baseline | 0.125 (0.000 to 1.375) |
| 2 weeks | 0.000 (0.000 to 0.656) |
| 6 weeks | 0.063 (0.000 to 0.688) |
| 12 weeks | 0.000 (0.000 to 0.625) |
| 24 weeks | 0.125 (0.000 to 0.313) |
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.
| score on a scale | SVF Injection Group |
|---|---|
| Baseline | 0.000 (0.000 to 0.125) |
| 2 weeks | 0.000 (0.000 to 0.063) |
| 6 weeks | 0.000 (0.000 to 0.094) |
| 12 weeks | 0.000 (0.000 to 0.188) |
| 24 weeks | 0.125 (0.000 to 0.313) |
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.
| score on a scale | SVF Injection Group |
|---|---|
| Baseline | 2.188 (1.469 to 2.406) |
| 2 weeks | 2.063 (1.438 to 2.500) |
| 6 weeks | 2.063 (1.625 to 2.344) |
| 12 weeks | 2.000 (1.438 to 2.563) |
| 24 weeks | 2.250 (1.313 to 2.563) |
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.
| score on a scale | SVF Injection Group |
|---|---|
| Baseline | 0.688 (0.188 to 1.625) |
| 2 weeks | 0.688 (0.563 to 1.906) |
| 6 weeks | 0.688 (0.000 to 1.688) |
| 12 weeks | 0.875 (0.000 to 1.875) |
| 24 weeks | 0.375 (0.000 to 1.938) |
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.
| score on a scale | SVF Injection Group |
|---|---|
| Baseline | 0.125 (0.000 to 0.375) |
| 2 weeks | 0.125 (0.000 to 0.438) |
| 6 weeks | 0.000 (0.000 to 1.688) |
| 12 weeks | 0.063 (0.000 to 0.594) |
| 24 weeks | 0.125 (0.000 to 0.375) |
Collected over Up to 24 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SVF Injection Group | 0/20 (0%) | 0/20 (0%) | 5/20 (25%) |
| Event | SVF Injection Group |
|---|---|
| Transient pallor in finger after injectionInjury, poisoning and procedural complications | 3/20 |
| Transient paresthesia in liposuction lesionsInjury, poisoning and procedural complications | 1/20 |
| Dizziness after lidocaine injectionInjury, poisoning and procedural complications | 1/20 |
| Age, Continuous(years) | SVF Injection |
|---|---|
| Median | 47 (42 to 57) |
| Sex: Female, Male(Participants) | SVF Injection |
|---|---|
| Female | 15 |
| Male | 3 |
| Race and Ethnicity Not Collected(Participants) | SVF Injection |
|---|
| Region of Enrollment(participants) | SVF Injection |
|---|---|
| South Korea | 20 |
| Body mass index (BMI) kg/m2(kg/m2) | SVF Injection |
|---|---|
| Median | 21.5 (18.2 to 23.1) |
| Disease duration (years)(years) | SVF Injection |
|---|---|
| Median | 6 (1 to 17) |
| Reynaud's phenomenon duration(years) | SVF Injection |
|---|---|
| Median | 9 (4 to 17) |
| Smoking history (Current or ex-)(Participants) | SVF Injection |
|---|---|
| Count of participants | 3 |
20 further baseline measures are reported on the registry.
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