Back to resultsInjection of Autologous Adipose-derived Stromal Vascular Fraction in the Finger of Systemic Sclerosis Patients
Primary Purpose
Systemic Sclerosis
Status
Completed
Phase
Early Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
SVF injection
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Sclerosis focused on measuring stromal vascular fraction, hand disability, mesenchymal stem cells, phase I trial
Eligibility Criteria
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
Sites / Locations
- Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SVF injection
Arm Description
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
Outcomes
Primary Outcome Measures
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)
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)
Colchin Hand Function Scale
The Colchin hand function scale (CHFS, ranging 0 to 90, with higher scores representing more deteriorated hand function) scores
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.
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.
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
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)
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)
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
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
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03060551
Brief Title
Injection of Autologous Adipose-derived Stromal Vascular Fraction in the Finger of Systemic Sclerosis Patients
Official Title
Safety, Tolerability and Potential Efficacy of Injection of Autologous Adipose-derived Stromal Vascular Fraction in the Finger of Systemic Sclerosis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Suk-Ho Moon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis
Keywords
stromal vascular fraction, hand disability, mesenchymal stem cells, phase I trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Systemic sclerosis patients with hand disability, planning 24 weeks of follow-up period Autologous adipose tissue-derived stromal vascular fraction(SVF) injected into the subcutaneous tissue of each finger in contact with neurovascular pedicles.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SVF injection
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
SVF injection
Intervention Description
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
Primary Outcome Measure Information:
Title
Raynaud's Condition Scale
Description
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
Title
Hand Visual Analogue Scale
Description
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
Title
Colchin Hand Function Scale
Description
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
Title
Kapandji Score (Ranging 0 to 10) - Dominant Hand
Description
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
Title
Kapandji Score (Non-dominant Hand)
Description
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
Title
Disease-related QOL (Quality of Life) : EuroQol-5 Dimensions Time Trade-off (EQ-5D TTO)
Description
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
Title
Disease-related QOL (Quality of Life) : EuroQol Visual Analog Scale (EQ VAS)
Description
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
Title
Disease-related QOL (Quality of Life) : Health Assessment Questionnaire (HAQ)
Description
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
Title
The Degree of Hand Edema (Right)
Description
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
Title
The Degree of Hand Edema (Left)
Description
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
Secondary Outcome Measure Information:
Title
Changes of Nailfold Capillary Microscopic Findings (Irregularly Enlarged Capillaries)
Description
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
Title
Changes of Nailfold Capillary Microscopic Findings (Giant Capillaries)
Description
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
Title
Changes of Nailfold Capillary Microscopic Findings (Hemorrhages)
Description
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
Title
Changes of Nailfold Capillary Microscopic Findings (Loss of Capillaries)
Description
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
Title
Changes of Nailfold Capillary Microscopic Findings (Disorganization of the Vascular Array)
Description
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
Title
Changes of Nailfold Capillary Microscopic Findings (Capillary Ramifications)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suk-Ho Moon, MD, PhD
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Seung-Ki Kwok
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32961802
Citation
Park Y, Lee YJ, Koh JH, Lee J, Min HK, Kim MY, Kim KJ, Lee SJ, Rhie JW, Kim WU, Park SH, Moon SH, Kwok SK. Clinical Efficacy and Safety of Injection of Stromal Vascular Fraction Derived from Autologous Adipose Tissues in Systemic Sclerosis Patients with Hand Disability: A Proof-Of-Concept Trial. J Clin Med. 2020 Sep 19;9(9):3023. doi: 10.3390/jcm9093023.
Results Reference
derived
Learn more about this trial
Injection of Autologous Adipose-derived Stromal Vascular Fraction in the Finger of Systemic Sclerosis Patients
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