Evidence map›Paper›PMID 26793290›Full record

ReviewOrthopedic reviews2015

Non-Hematopoietic Essential Functions of Bone Marrow Cells: A Review of Scientific and Clinical Literature and Rationale for Treating Bone Defects.

David B Harrell, Eugenio Caradonna, Laura Mazzucco, Rosmarie Gudenus, Berthold Amann, Vaclav Prochazka, Peter V Giannoudis, Christian Hendrich, Marcus Jäger, Rüdiger Krauspe and 1 more

Abstract readReview
In one paragraph

Review in Orthopedic reviews, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. 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

11 authors.

David B HarrellHarrell BioScience Consulting LLC , Quincy, MA, USA.
Eugenio CaradonnaDepartment of Cardiovascular Disease, Fondazione de Ricerca e Cura Giovanni e Paolo II , Campbasso, Italy.
Laura MazzuccoBlood Component and Regenerative Medicine Laboratory, Alessandria Hospital , Italy.
Rosmarie GudenusGranzer Regulatory Consulting and Services , München, Germany.
Berthold AmannASKLEPIOS Westklinikum Hamburg , Germany.
Vaclav ProchazkaInterventional Neuroradiology and Angiology, University of Ostrava , Czech Republic.
Peter V GiannoudisTrauma and Orthopedic Surgery School of Medicine, University of Leeds , UK.
Christian HendrichOrthopaedishe Krankenhaus Schloss Werneck, Werneck Bayern , Germany.
Marcus JägerUniversitätklinikum Essen , Germany.
Rüdiger KrauspeKlinik Orthopaedische, University of Düsseldorf , Germany.
Philippe HernigouHôspital Henri Mondor , Creteil, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Hematopoiesis as the only essential function of bone marrow cells has been challenged for several decades through basic science (in vitro and in vivo) and clinical data. Such work has shed light on two other essential functions of bone marrow cells: osteopoiesis and angio-genesis/vasculogenesis. Clinical utility of autologous concentrated bone marrow aspirate (CBMA) has demonstrated both safety and efficacy in treating bone defects. Moreover, CBMA has been shown to be comparable to the gold standard of iliac crest bone graft (ICBG), or autograft, with regard to being osteogenic and osteoinductive. ICBG is not considered an advanced therapy medicinal product (ATMP), but CBMA may become regulated as an ATMP. The European Medicines Agency Committee for Advanced Therapies (EMA:CAT) has issued a reflection paper (20 June 2014) in which reversal of the 2013 ruling that CBMA is a non-ATMP has been proposed. We review bone marrow cell involvement in osteopoiesis and angiogenesis/vasculogenesis to examine EMA:CAT 2013 decision to use CBMA for treatment of osteonecrosis (e.g, of the femoral head) should be considered a non-ATMP. This paper is intended to provide discussion on the 20 June 2014 reflection paper by reviewing two non-hematopoietic essential functions of bone marrow cells. Additionally, we provide clinical and scientific rationale for treating osteonecrosis with CBMA.

Indexed as

angiogenesisConcentrated bone marrow aspiratehematopoiesisosteonecrosisosteopoiesis

Identifiers

PMID26793290
PMCPMC4703908

What OpenQuestion holds

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Registered trials

None linked

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.