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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2019-12-30

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

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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.

Conditions

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Systemic Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SVF injection

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

Group Type EXPERIMENTAL

SVF injection

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No