Evidence map›Paper›PMID 25114060›Full record

Trial reportAnnals of the rheumatic diseases2015

Safety, tolerability and potential efficacy of injection of autologous adipose-derived stromal vascular fraction in the fingers of patients with systemic sclerosis: an open-label phase I trial.

Brigitte Granel, Aurélie Daumas, Elisabeth Jouve, Jean-Robert Harlé, Pierre-Sébastien Nguyen, Christian Chabannon, Nathalie Colavolpe, Jean-Charles Reynier, Romain Truillet, Stéphanie Mallet and 7 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 90 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
90citing papers in PubMed, 5 pooled it
11.8field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01813279 nacompletednot on this map

Assessment of the Subcutaneous Reinjection of Human Autologous Adipose-derived Stromal Vascular Fraction (Celution® System) in the Hands of Patients Suffering From Systemic Sclerosis

TypeinterventionalSponsorAssistance Publique Hopitaux De MarseilleRan2012 to 2014Enrolled12ConditionsSystemic SclerosisArmsthe cell therapy
NCT05016804 phase1recruitingnot on this mapstarted 2022, after this paper: background citation

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Systemic Sclerosis

TypeinterventionalSponsorThe Foundation for Orthopaedics and Regenerative MedicineRan2022 to 2026Enrolled20ConditionsSystemic SclerosisArmsAlloRx
3 · Its place in the literature

Who cites it

90 citing papers in PubMed, 5 syntheses or guidelines pooled it, 187 citations in OpenAlex.

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  12. Utilization of Stem Cells in Medicine: A Narrative Review.International journal of molecular sciences · 2025
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  15. Stem cell therapy in systemic sclerosis.Clinical rheumatology · 2025
    Review
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30 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 4 institutions in 1 country.

Brigitte GranelInternal Medicine Department, Assistance Publique Hôpitaux de Marseilles (AP-HM), Aix-Marseilles University, Marseilles, France Vascular Research Center Marseille, INSERM UMRS-1076, Aix-Marseilles University, Marseilles, France.
Aurélie DaumasInternal Medicine Department, Assistance Publique Hôpitaux de Marseilles (AP-HM), Aix-Marseilles University, Marseilles, France.
Elisabeth JouveCIC- CPCET, Assistance Publique Hôpitaux de Marseilles (AP-HM), Aix-Marseilles University, Marseilles, France.
Jean-Robert HarléInternal Medicine Department, Assistance Publique Hôpitaux de Marseilles (AP-HM), Aix-Marseilles University, Marseilles, France.
Pierre-Sébastien NguyenPlastic Surgery Department, Assistance Publique Hôpitaux de Marseilles (AP-HM), Aix-Marseilles University, Marseilles, France.
Christian ChabannonCell Therapy Facility & Inserm CBT 510, Institut Paoli Calmettes, Marseilles, France.
Nathalie ColavolpeDepartment of Radiology, Assistance Publique Hôpitaux de Marseille (AP-HM), Aix-Marseilles University, Marseilles, France.
Jean-Charles ReynierDélégation de la Recherche et de l'Innovation, Assistance Publique Hôpitaux de Marseilles (AP-HM), Marseilles, France.
Romain TruilletCIC- CPCET, Assistance Publique Hôpitaux de Marseilles (AP-HM), Aix-Marseilles University, Marseilles, France.
Stéphanie MalletDepartment of Dermatology, Assistance Publique Hôpitaux de Marseilles (AP-HM), Aix-Marseilles University, Marseilles, France.
Antoine BaiadaPlastic Surgery Department, Assistance Publique Hôpitaux de Marseilles (AP-HM), Aix-Marseilles University, Marseilles, France.
Dominique CasanovaPlastic Surgery Department, Assistance Publique Hôpitaux de Marseilles (AP-HM), Aix-Marseilles University, Marseilles, France.
Laurent GiraudoCulture and Cell Therapy Laboratory, INSERM CBT 510, Assistance Publique Hôpitaux de Marseilles (AP-HM), Aix-Marseilles University, Marseilles, France.
Laurent ArnaudHematology and Vascular Biology Laboratory, Assistance Publique Hôpitaux de Marseilles (AP-HM), Aix-Marseilles University, Marseilles, France.
Julie VeranCulture and Cell Therapy Laboratory, INSERM CBT 510, Assistance Publique Hôpitaux de Marseilles (AP-HM), Aix-Marseilles University, Marseilles, France.
Florence SabatierVascular Research Center Marseille, INSERM UMRS-1076, Aix-Marseilles University, Marseilles, France Culture and Cell Therapy Laboratory, INSERM CBT 510, Assistance Publique Hôpitaux de Marseilles (AP-HM), Aix-Marseilles University, Marseilles, France Hematology and Vascular Biology Laboratory, Assistance Publique Hôpitaux de Marseilles (AP-HM), Aix-Marseilles University, Marseilles, France.
Guy MagalonPlastic Surgery Department, Assistance Publique Hôpitaux de Marseilles (AP-HM), Aix-Marseilles University, Marseilles, France Culture and Cell Therapy Laboratory, INSERM CBT 510, Assistance Publique Hôpitaux de Marseilles (AP-HM), Aix-Marseilles University, Marseilles, France.
Assistance Publique Hôpitaux de Marseille · FRInserm · FRAix-Marseille Université · FRInstitut Paoli-Calmettes · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn patients with systemic sclerosis (scleroderma, SSc), impaired hand function greatly contributes to disability and reduced quality of life, and is insufficiently relieved by currently available therapies. Adipose tissue-derived stromal vascular fraction (SVF) is increasingly recognised as an easily accessible source of regenerative cells with therapeutic potential in ischaemic or autoimmune diseases. We 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.

methodsWe did an open-label, single arm, at one study site with 6-month follow-up among 12 female SSc patients with Cochin Hand Function Scale score >20/90. Autologous 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. Primary outcome was the number and the severity of adverse events related to SVF-based therapy. Secondary endpoints were changes in hand disability and fibrosis, vascular manifestations, pain and quality of life from baseline to 2 and 6 months after cell therapy.

findingsAll enrolled patients had surgery, and there were no dropouts or patients lost to follow-up. No severe adverse events occurred during the procedure and follow-up. Four minor adverse events were reported and resolved spontaneously. A significant improvement in hand disability and pain, Raynaud's phenomenon, finger oedema and quality of life was observed.

interpretationThis study outlines the safety of the autologous SVF cells injection in the hands of patients with SSc. Preliminary assessments at 6 months suggest potential efficacy needing confirmation in a randomised placebo-controlled trial on a larger population.

fundingGFRS (Groupe Francophone de Recherche sur la Sclérodermie). CLINICAL TRIALS NUMBER: NCT01813279.

Indexed as

AdultAgedDisability EvaluationFemaleFingersHumansInjectionsMaleMesenchymal Stem Cell TransplantationMiddle AgedQuality of LifeScleroderma, SystemicTransplantation, AutologousTreatment OutcomeAutoimmune DiseasesSystemic SclerosisTreatment

Identifiers

PMID25114060
PMCPMC4680117
OpenAlexW2135570337

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.