Evidence map›Paper›PMID 26021713›Full record

Trial reportStem cell research & therapy2015

Efficacy of autologous stem cell-based therapy for osteonecrosis of the femoral head in sickle cell disease: a five-year follow-up study.

Gildasio Cerqueira Daltro, Vitor Fortuna, Eliane Silva de Souza, Marcela Miranda Salles, Ana Claudia Carreira, Roberto Meyer, Songeli Menezes Freire, Radovan Borojevic

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Stem cell research & therapy, 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 48 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 5 pooled it
5.8field-weighted citation impact, top 4% 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.

NCT02448121 phase1 / phase2unknown statusnot on this map

Treatment for Hip, Knee, Ankle and Shoulder Osteonecrosis With Autologous Mononuclear Cells Transplantation in People With Sickle Cell Disease

TypeinterventionalSponsorFederal University of BahiaRan2006 to 2018Enrolled100ConditionsAvascular Necrosis of Bone, Sickle Cell DiseaseArmsAutologous bone marrow stem cell graft
NCT02619734 phase1unknown statusnot on this map

Efficacy and Safety of Autologous Bone Marrow Stem Cells Infusion for Treatment of Chronic Leg Ulcer in Sickle Cell Disease Patients

TypeinterventionalSponsorFederal University of BahiaRan2006 to 2016Enrolled40ConditionsChronic Leg Ulcer, Sickle Cell DiseaseArmsInfusion of Autologous Bone Marrow Mononuclear Cells
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 5 syntheses or guidelines pooled it, 87 citations in OpenAlex.

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  15. Cellular therapies for bone repair: current insights.Journal of orthopaedics and traumatology : official journal of the Italian Society of Orthopaedics and Traumatology · 2024
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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

8 authors at 4 institutions in 1 country.

Gildasio Cerqueira DaltroProf. Edgar Santos Hospital Complex, Salvador, BA, 40110-902, Brazil. gildasio.daltro@yahoo.com.br.
Vitor FortunaHealth Science Institute, Federal University of Bahia, Reitor Miguel Calmon Avenue, Salvador, BA, 40110-100, Brazil. vfort@ufba.br.
Eliane Silva de SouzaHealth Science Institute, Federal University of Bahia, Reitor Miguel Calmon Avenue, Salvador, BA, 40110-100, Brazil. elifarufba@yahoo.com.br.
Marcela Miranda SallesHealth Science Institute, Federal University of Bahia, Reitor Miguel Calmon Avenue, Salvador, BA, 40110-100, Brazil. celafarma@yahoo.com.br.
Ana Claudia CarreiraCell and Molecular Therapy Center NUCEL-NETCEM, School of Medicine, Internal Medicine Department, and Chemistry Institute, Biochemistry Department, University of São Paulo, São Paulo, SP, 05508-900, Brazil. ancoc@iq.usp.br.
Roberto MeyerHealth Science Institute, Federal University of Bahia, Reitor Miguel Calmon Avenue, Salvador, BA, 40110-100, Brazil. rmeyer@ufba.br.
Songeli Menezes FreireHealth Science Institute, Federal University of Bahia, Reitor Miguel Calmon Avenue, Salvador, BA, 40110-100, Brazil. songeli.mf@gmail.com.
Radovan BorojevicPetrópolis School of Medicine/Arthur de Sá Earp Faculties, Petrópolis, RJ, 25680-120, Brazil. rrborojevic@gmail.com.
Universidade Federal da Bahia · BRComplexo Hospitalar Universitário Professor Edgard Santos · BRInstituto Nacional de Metrologia, Qualidade e Tecnologia · BRUniversidade de São Paulo · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionStem cell therapy with bone marrow-derived mononuclear cells (BMMCs) is an option for improving joint function in osteonecrosis of the femoral head (ONFH). Bone marrow-derived mesenchymal stromal cell (MSC) numbers and their osteogenic differentiation are decreased in patients with ONFH. However, whether this decrease also extends to the early stages of ONFH in sickle cell disease (SCD) is still unclear.

methodsWe conducted a phase I/II, non-controlled study to determine efficacy and safety of BMMC implantation using a minimally invasive technique in SCD patients with ONFH. Eighty-nine patients were recruited and followed up for 60 months after surgery. Clinical and radiographic findings were assessed, and data were completed by in vitro analysis.

resultsAt the final follow-up (60 months) there was a significant improvement in clinical joint symptoms and pain relief as measured by the Harris Hip Score (P = 0.0005). In addition, after the BMMC implantation procedure, radiographic assessment showed disease stabilization and only 3.7 % of the treated patients did not achieve a satisfactory clinical result. The amount of fibroblast colony-forming units was 28.2 ± 13.9 per 1 million BMMCs after concentration. Flow cytometry analysis showed a significantly higher number of hematopoietic stem/endothelial progenitor cell markers in concentrated BMMCs when compared with bone marrow aspirate, indicating an enrichment of these cell types. Isolated MSCs from SCD patients with pre-collapse ONFH maintained the replicative capacity without significant loss of their specific biomolecular characteristics, multi-differentiation potential, and osteogenic differentiation activities. Cytokines and growth factors (interleukin-8, transforming growth factor-beta, stromal cell-derived factor-1alpha and vascular endothelial growth factor) that mediate endogenous bone regeneration were also produced by expanded MSCs from SCD patients.

conclusionThe autologous BMMC implantation with a minimally invasive technique resulted in significant pain relief and halted the progression of early stages of ONFH in SCD patients. MSCs from SCD patients display biological properties that may add to the efficiency of surgical treatment in ONFH. In summary, our results indicate that infusion of BMMCs enriched with stem/progenitor cells is a safe and effective treatment for the early stages of ONFH in SCD patients.

trial registrationClinicalTrials.gov NCT02448121; registered 15 May 2015.

Indexed as

Stem Cell TransplantationAdipogenesisAdolescentAdultAnemia, Sickle CellAntigens, CDBone Marrow CellsChondrogenesisCytokinesFemaleFemur Head NecrosisFollow-Up StudiesHipHumansImmunophenotypingMaleAntigens, CDCytokines

Identifiers

PMID26021713
PMCPMC4465459
OpenAlexW1497383098

What OpenQuestion holds

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LicenceCC BY
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.