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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 angiogenesis/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.

The authors describe a step-by-step technique for reverse total shoulder arthroplasty using arthrotomy via the enlarged transacromial superior approach. This technique seems ideal for reinsertion of the tuberosities and to ensure adequate postoperative tensional balance of the infraspinatus and the subscapularis, which is critical for the rotator cuffs to function properly and to achieve optimal arthroplasty stability. Reviewing these different steps helps understanding each rotator cuff individual component's contribution to achieve optimal arthroplasty stability and external rotation with a reverse shoulder arthroplasty.

Although the presence of osteonecrotic bone is known to make joints more prone to infection, acute septic joint in hip osteonecrosis has not frequently been reported in adults with sickle cell disease. The clinical features at the time of admission, imaging findings suggesting the diagnosis, modes of treatment and sequelae of septic arthritis of twenty-four hip joints with osteonecrosis in patients with sickle cell disease were studied retrospectively over a 25-years period. This study evaluated also the complications, the efficiency and the risk of total hip arthroplasty in these patients. Most patients were in the third decade of life. Staphylococcus and Gram negative infection predominated. Treatment was first conservative but most of the patients needed surgery to treat infection and sequelae related to infection. A total hip arthroplasty was performed later in twenty joints. No deaths were observed, but complications occurred. Twenty of the patients in our study underwent delayed total hip arthroplasties following repeated aspirations of the joint and intravenous antibiotics. With an experienced surgical and medical team and multidisciplinary management of these patients undergoing total hip arthroplasty after hip infection, our rate of complications was acceptable.

In addition to osteosynthetic stabilizing techniques and autologous bone transplantations, so-called orthobiologics play an increasing role in the treatment of bone healing disorders. Besides the use of various growth factors, more and more new data suggest that cell-based therapies promote local bone regeneration. For ethical and biological reasons, clinical application of progenitor cells on the musculoskeletal system is limited to autologous, postpartum stem cells. Intraoperative one-step treatment with autologous progenitor cells, in particular, delivered promising results in preliminary clinical studies. This article provides an overview of the rationale for, and characteristics of the clinical application of cell-based therapy to treat osseous defects based on a review of existing literature and our own experience with more than 100 patients. Most clinical trials report successful bone regeneration after the application of mixed cell populations from bone marrow. The autologous application of human bone marrow cells which are not expanded ex vivo has medico-legal advantages. However, there is a lack of prospective randomized studies including controls for cell therapy for bone defects. Autologous bone marrow cell therapy seems to be a promising treatment option which may reduce the amount of bone grafting in future.

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 angiogenesis/ 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. [ABSTRACT FROM AUTHOR]

Although the presence of osteonecrotic bone is known to make joints more prone to infection, acute septic joint in hip osteonecrosis has not frequently been reported in adults with sickle cell disease. The clinical features at the time of admission, imaging findings suggesting the diagnosis, modes of treatment and sequelae of septic arthritis of twenty-four hip joints with osteonecrosis in patients with sickle cell disease were studied retrospectively over a 25-years period. This study evaluated also the complications, the efficiency and the risk of total hip arthroplasty in these patients. Most patients were in the third decade of life. Staphylococcus and Gram negative infection predominated. Treatment was first conservative but most of the patients needed surgery to treat infection and sequelae related to infection. A total hip arthroplasty was performed later in twenty joints. No deaths were observed, but complications occurred. Twenty of the patients in our study underwent delayed total hip arthroplasties following repeated aspirations of the joint and intravenous antibiotics. With an experienced surgical and medical team and multidisciplinary management of these patients undergoing total hip arthroplasty after hip infection, our rate of complications was acceptable. [ABSTRACT FROM AUTHOR]

In addition to osteosynthetic stabilizing techniques and autologous bone transplantations, so-called orthobiologics play an increasing role in the treatment of bone healing disorders. Besides the use of various growth factors, more and more new data suggest that cell-based therapies promote local bone regeneration. For ethical and biological reasons, clinical application of progenitor cells on the musculoskeletal system is limited to autologous, postpartum stem cells. Intraoperative one-step treatment with autologous progenitor cells, in particular, delivered promising results in preliminary clinical studies. This article provides an overview of the rationale for, and characteristics of the clinical application of cell-based therapy to treat osseous defects based on a review of existing literature and our own experience with more than 100 patients. Most clinical trials report successful bone regeneration after the application of mixed cell populations from bone marrow. The autologous application of human bone marrow cells which are not expanded ex vivo has medico-legal advantages. However, there is a lack of prospective randomized studies including controls for cell therapy for bone defects. Autologous bone marrow cell therapy seems to be a promising treatment option which may reduce the amount of bone grafting in future. [ABSTRACT FROM AUTHOR]