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Adipose tissue-derived stromal vascular fraction for treating hands of patients with systemic sclerosis: a multicentre randomized trial Autologous AD-SVF versus placebo in systemic sclerosis
- Source :
- Rheumatology, Rheumatology, 2021, pp.keab584. ⟨10.1093/rheumatology/keab584⟩
- Publication Year :
- 2021
-
Abstract
- Objective To assess the superiority of adipose tissue-derived stromal vascular fraction (AD-SVF) injection into the fingers vs placebo in reducing hand disability in systemic sclerosis (SSc) patients. Methods We performed a double-blind, multicentre, phase II trial from October 2015 to January 2018 in France. SSc patients with a Cochin Hand Function Scale (CHFS) ≥20/90 were randomized 1:1 to receive injection of AD-SVF or placebo. AD-SVF was obtained using the automated processing Celution 800/CRS system. The placebo was lactated Ringer’s solution. The primary efficacy end point was the change of the CHFS score from baseline to 3 months. Secondary efficacy endpoints included the CHFS score at 6 months, hand function, vasculopathy, hand pain, skin fibrosis, sensitivity of the finger pulps, Scleroderma Health Assessment Questionnaire, patients and physician satisfaction, and safety. Results Forty patients were randomized. The AD-SVF and placebo groups were comparable for age, sex ratio, disease duration, skin fibrosis of the hands and main cause of hand disability. After 3 months’ follow-up, hand function significantly improved in both groups with no between-group difference of CHFS (mean change of −9.2 [12.2] in the AD-SVF group vs −7.6 [13.2] in the placebo group). At 6 months, hand function improved in both groups. Conclusion This study showed an improvement of hand function in both groups over time, with no superiority of the AD-SVF. Considering the limits of this trial, studies on a larger population of patients with homogeneous phenotype and hand handicap should be encouraged to accurately assess the benefit of AD-SVF therapy. Trial registration ClinicalTrials.gov, https://clinicaltrials.gov, NCT02558543. Registered on September 24, 2015.
- Subjects :
- medicine.medical_specialty
Population
Adipose tissue
Placebo
Scleroderma
law.invention
Rheumatology
Randomized controlled trial
law
Fibrosis
Internal medicine
CHFS
medicine
Humans
Pharmacology (medical)
education
education.field_of_study
Scleroderma, Systemic
Stromal Vascular Fraction
business.industry
Stromal vascular fraction
medicine.disease
Hand
Autologous adipose tissue-derived stromal vascular fraction
[SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system
Adipose Tissue
Regenerative medicine
Systemic sclerosis
business
Cochin Hand Function Scale
Subjects
Details
- ISSN :
- 14620332, 14620324, and 14602172
- Volume :
- 61
- Issue :
- 5
- Database :
- OpenAIRE
- Journal :
- Rheumatology (Oxford, England)
- Accession number :
- edsair.doi.dedup.....f032ad15cf7d97b1723b515b9c1958cd