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

Safety, Tolerability and Potential Efficacy of 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

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.

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