Systemic Sclerosis Clinical Trial
Official title:
Safety, Tolerability and Potential Efficacy of Injection of Autologous Adipose-derived Stromal Vascular Fraction in the Finger of Systemic Sclerosis Patients
Verified date | October 2020 |
Source | Seoul St. Mary's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 20 |
Est. completion date | December 30, 2019 |
Est. primary completion date | December 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea | Seoul |
Lead Sponsor | Collaborator |
---|---|
Suk-Ho Moon |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks | |
Primary | 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) | Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks | |
Primary | Colchin Hand Function Scale | The Colchin hand function scale (CHFS, ranging 0 to 90, with higher scores representing more deteriorated hand function) scores | Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks | |
Primary | 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. | Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks | |
Primary | 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. | Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks | |
Primary | 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 | Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks | |
Primary | 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) | Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks | |
Primary | 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) | Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks | |
Primary | 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 | Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks | |
Primary | 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 | Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks | |
Secondary | 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. | Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks | |
Secondary | 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. | Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks | |
Secondary | 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. | Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks | |
Secondary | 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. | Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks | |
Secondary | 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. | Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks | |
Secondary | 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. | Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks |
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