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Completed

NCT Number: NCT03060551

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

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

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Key information

Conditions

Systemic Sclerosis Connective Tissue Diseases Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SVF injection

Procedure

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 outcomes

  1. Raynaud's Condition Scale

    Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

    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)

  2. Hand Visual Analogue Scale

    Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

    Hand pain was assessed using the Hand visual analogue scale (ranging 0 to 10, with higher scores representing more severe pain)

  3. Colchin Hand Function Scale

    Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

    The Colchin hand function scale (CHFS, ranging 0 to 90, with higher scores representing more deteriorated hand function) scores

  4. Kapandji Score (Ranging 0 to 10) - Dominant Hand

    Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

    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.

  5. Kapandji Score (Non-dominant Hand)

    Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

    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.

  6. Disease-related QOL (Quality of Life) : EuroQol-5 Dimensions Time Trade-off (EQ-5D TTO)

    Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

    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

  7. Disease-related QOL (Quality of Life) : EuroQol Visual Analog Scale (EQ VAS)

    Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

    Disease-related QOL (quality of life) : EuroQol visual analog scale (EQ VAS, ranging 0 to 100, with higher scores representing better QOL)

  8. Disease-related QOL (Quality of Life) : Health Assessment Questionnaire (HAQ)

    Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

    Disease-related QOL (quality of life) : health assessment questionnaire (HAQ, ranging 0 to 3, with higher scores meaning lower QOL)

  9. The Degree of Hand Edema (Right)

    Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

    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

  10. The Degree of Hand Edema (Left)

    Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

    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 outcomes

  1. Changes of Nailfold Capillary Microscopic Findings (Irregularly Enlarged Capillaries)

    Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

    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.

  2. Changes of Nailfold Capillary Microscopic Findings (Giant Capillaries)

    Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

    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.

  3. Changes of Nailfold Capillary Microscopic Findings (Hemorrhages)

    Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

    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.

  4. Changes of Nailfold Capillary Microscopic Findings (Loss of Capillaries)

    Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

    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.

  5. Changes of Nailfold Capillary Microscopic Findings (Disorganization of the Vascular Array)

    Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

    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.

  6. Changes of Nailfold Capillary Microscopic Findings (Capillary Ramifications)

    Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

    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.

Sponsors and collaborators

Lead sponsor

Suk-Ho Moon

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 23, 2017
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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