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

Suk-Ho Moon

Status and phase: Completed; Early Phase 1

Conditions: Systemic Sclerosis

Treatments: Procedure: SVF injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03060551

SVF treatment in SSc

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

SVF injection

Experimental group

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

Treatment:

Procedure: SVF injection