Evidence map›Paper›PMID 41503586›Full record

ArticleStem cells international2026

Safety, Feasibility, and Preliminary Efficacy of Allogeneic MSCs to Treat Advanced Femoral Head Osteonecrosis (ALOFEM): A Pilot Study in Young Onco-Hematological Patients.

Enrique Gómez-Barrena, Norma G Padilla-Eguiluz, Juan Cabello-Blanco, José Juan Pozo-Kreilinger, Yasmina Mozo-Del-Castillo, María E Martínez-Muñoz, Trinidad Martín-Donaire, Rocío Zafra, Rafael F Duarte, Ana Velasco-Iglesias and 2 more

Abstract read
In one paragraph

Article in Stem cells international, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

12 authors.

Enrique Gómez-BarrenaDepartment of Orthopedic Surgery, La Paz University Hospital-IdiPAZ, Madrid, Spain, idipaz.es.ORCID https://orcid.org/0000-0002-6829-9710
Norma G Padilla-EguiluzDepartment of Surgery, School of Medicine, Autonomous University of Madrid-IdiPAZ, Madrid, Spain.ORCID https://orcid.org/0000-0001-5179-9367
Juan Cabello-BlancoDepartment of Orthopedic Surgery, La Paz University Hospital-IdiPAZ, Madrid, Spain, idipaz.es.ORCID https://orcid.org/0000-0002-3058-3353
José Juan Pozo-KreilingerDepartment of Pathology, La Paz University Hospital, Madrid, Spain, hulp.es.ORCID https://orcid.org/0000-0001-5895-4112
Yasmina Mozo-Del-CastilloDepartment of Pediatric of Onco-Hematology, La Paz University Hospital, Madrid, Spain, hulp.es.ORCID https://orcid.org/0000-0002-5666-1911
María E Martínez-MuñozDepartment of Hematology and GMP Cell Production Unit, Puerta de Hierro Majadahonda University Hospital, Madrid, Spain, madrid.org.
Trinidad Martín-DonaireDepartment of Hematology and GMP Cell Production Unit, Puerta de Hierro Majadahonda University Hospital, Madrid, Spain, madrid.org.ORCID https://orcid.org/0009-0002-9562-1100
Rocío ZafraDepartment of Hematology and GMP Cell Production Unit, Puerta de Hierro Majadahonda University Hospital, Madrid, Spain, madrid.org.ORCID https://orcid.org/0009-0001-6451-3580
Rafael F DuarteDepartment of Hematology and GMP Cell Production Unit, Puerta de Hierro Majadahonda University Hospital, Madrid, Spain, madrid.org.ORCID https://orcid.org/0000-0002-5240-9815
Ana Velasco-IglesiasDepartment of Clinical Pharmacology, Puerta de Hierro-Majadahonda University Hospital, Madrid, Spain, madrid.org.ORCID https://orcid.org/0009-0001-0537-7347
Cristina Avendaño-SolàDepartment of Clinical Pharmacology, Puerta de Hierro-Majadahonda University Hospital, Madrid, Spain, madrid.org.ORCID https://orcid.org/0000-0001-5437-7215
Concepción Payares-HerreraDepartment of Clinical Pharmacology, Puerta de Hierro-Majadahonda University Hospital, Madrid, Spain, madrid.org.ORCID https://orcid.org/0009-0001-7041-1564

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Severe osteonecrosis of the femoral head (ONFH) secondary to corticosteroid therapy in symptomatic, hematological young patients currently has no therapeutic alternative, and early total hip replacement (THR) is a high-risk intervention in those patients. Objectives: To evaluate feasibility, safety, and early efficacy of allogeneic expanded mesenchymal stromal cells (MSCs) in a pilot clinical trial. Methods: Pilot phase 1 open, noncontrolled, nonrandomized clinical trial evaluating the bone regeneration capacity in seven hips from four patients (young females 11-19 year old) with symptomatic, severe bilateral femoral head osteonecrosis (secondary to corticosteroid therapy), 1 year after being surgically treated with 140 × 10 Results: The proposed therapy proved feasibility, safety at 1 and 4 years (no related serious adverse events [SAEs]), and early efficacy (nonsignificant) in the case analysis (5/7 hips avoiding THR at 4 years). Conclusions: The implantation of expanded allogeneic MSC in young patients to prevent conversion to a THR or collapse of the femoral head due to severe osteonecrosis is feasible without safety concerns in the longer-term follow-up (FU) upto 4 years.

Indexed as

allogenic bone marrow derived MSCexpanded MSCsosteonecrosis of the femoral head (ONFH)pilot phase 1 clinical trial

Identifiers

PMID41503586
PMCPMC12771626

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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.