Injection of Autologous Adipose-derived Stromal Vascular Fraction in the Finger of Systemic Sclerosis Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety, Tolerability and Potential Efficacy of Injection of Autologous Adipose-derived Stromal Vascular Fraction in the Finger of Systemic Sclerosis Patients

Conditions
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Systemic Sclerosis

Intervention / Treatment
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* Procedure: SVF injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SVF injection<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stromal vascular fraction, hand disability, mesenchymal stem cells, phase I trial