Regulatory issues in clinical applications of cytokines and growth factors

1994 ◽  
Vol 5 (2) ◽  
pp. 213-222 ◽  
Author(s):  
Karen D. Weiss ◽  
Jay P. Siegel ◽  
Theresa L. Gerrard
Keyword(s):  
Growth Factors ◽  
Clinical Applications ◽  
Regulatory Issues

scholarly journals Commercial Bone Grafts Claimed as an Alternative to Autografts: Current Trends for Clinical Applications in Orthopaedics

Materials ◽  
2021 ◽  
Vol 14 (12) ◽  
pp. 3290
Author(s):  
Marco Govoni ◽  
Leonardo Vivarelli ◽  
Alessandro Mazzotta ◽  
Cesare Stagni ◽  
Alessandra Maso ◽  
...  
Keyword(s):  
Web Of Science ◽  
Bone Grafts ◽  
Clinical Applications ◽  
Bibliographic Databases ◽  
Market Demand ◽  
Regulatory Issues ◽  
Negative Results ◽  
Current Trends ◽  
Analyse Data ◽  
Cellular Bone

In the last twenty years, due to an increasing medical and market demand for orthopaedic implants, several grafting options have been developed. However, when alternative bone augmentation materials mimicking autografts are searched on the market, commercially available products may be grouped into three main categories: cellular bone matrices, growth factor enhanced bone grafts, and peptide enhanced xeno-hybrid bone grafts. Firstly, to obtain data for this review, the search engines Google and Bing were employed to acquire information from reports or website portfolios of important competitors in the global bone graft market. Secondly, bibliographic databases such as Medline/PubMed, Web of Science, and Scopus were also employed to analyse data from preclinical/clinical studies performed to evaluate the safety and efficacy of each product released on the market. Here, we discuss several products in terms of osteogenic/osteoinductive/osteoconductive properties, safety, efficacy, and side effects, as well as regulatory issues and costs. Although both positive and negative results were reported in clinical applications for each class of products, to date, peptide enhanced xeno-hybrid bone grafts may represent the best choice in terms of risk/benefit ratio. Nevertheless, more prospective and controlled studies are needed before approval for routine clinical use.

Growth Factors and Their Clinical Applications

2001 ◽  
Vol 8 (3) ◽  
pp. 372 ◽  
Author(s):  
Seong-Hwan Moon ◽  
Hak-Sun Kim ◽  
Hwan-Mo Lee
Keyword(s):  
Growth Factors ◽  
Clinical Applications

scholarly journals Basic Studies on the Clinical Applications of Platelet-Rich Plasma

2003 ◽  
Vol 12 (5) ◽  
pp. 509-518 ◽  
Author(s):  
Masaki Yazawa ◽  
Hisao Ogata ◽  
Tatsuo Nakajima ◽  
Taisuke Mori ◽  
Naohide Watanabe ◽  
...  
Keyword(s):  
Growth Factors ◽  
Growth Factor ◽  
Fibrin Glue ◽  
Transforming Growth Factor ◽  
Platelet Rich Plasma ◽  
Transforming Growth Factor Β ◽  
Clinical Applications ◽  
Platelet Concentrate ◽  
Platelet Concentrates ◽  
Basic Studies

Platelets, which contain many growth factors such as platelet-derived growth factor (PDGF) and transforming growth factor-β (TGF-β), are being used in clinical applications as platelet-rich plasma (PRP). Only a few studies, however, have been conducted on the growth factors present in PRP and on the clinical applications using the drug delivery system (DDS). For the purpose of clinical application, we first modified the PRP preparation method and assessed the amounts of growth factors contained in the human platelet concentrates. Furthermore, we assessed fibrin glue as a DDS of platelet concentrates. Platelet precipitations were made by twice centrifuging human whole blood. The precipitated platelet was resuspended to yield the platelet concentrates. The growth factor concentrations were measured. Fibrin glue sheets containing this platelet concentrate were implanted in rabbit pinna and samples were obtained for immunostaining (anti-PDGF antibody) to assess the use of PRP over time using the fibrin glue as the DDS. The mean concentration of growth factors present in the platelet concentrates was three times or greater than that of conventional PRP. Furthermore, the results indicated that when the platelet concentrate was used with fibrin glue as a carrier, the contents were released over a period of about 1 week. This raises the possibility that this system may be useful in clinical applications.

Mobilised Peripheral Blood Could Be a Suitable Source of Mesenchymal Stem Cells?.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 4103-4103
Author(s):  
Camillo Almici ◽  
Rosanna Verardi ◽  
Simona Braga ◽  
Arabella Neva ◽  
Domenico Russo ◽  
...  
Keyword(s):  
Stem Cells ◽  
Bone Marrow ◽  
Mesenchymal Stem Cells ◽  
Growth Factors ◽  
Peripheral Blood ◽  
Cellular Therapy ◽  
Cultured Cells ◽  
Basal Medium ◽  
Optimal Growth ◽  
Clinical Applications

Abstract Mesenchymal stem cells (MSC) are multipotent cells that are considered one of the most promising product for cellular therapy in regenerative medicine. MSC have been obtained and expanded from bone marrow and umbilical cord blood in adequate amounts for clinical applications. Under the right conditions, MSC could migrate from bone marrow into the peripheral circulation; however MSC have not been routinely isolated from peripheral blood, and studies are rare and not conclusive. The aim of the present study was to evaluate mobilised peripheral blood (MPB), obtained from patients undergoing apheresis collection of circulating hematopoietic progenitor cells, as a potential source of MSC for clinical applications. MPB samples (500–900 × 106 cells, N = 17) were separated by negative lineage-depletion immunoselection (RosetteSep). Selected cells were seeded in multi-well plates at low density in MesenCult Basal Medium without and with different combinations of growth factors (EGF, PDGF-BB, b-FGF). On reaching confluence, adherent cells were detached by 0.25% trypsin-EDTA treatment and replated for at least two passages. At each passage, surface antigen expression was analyzed by flowcytometry (CD45, CD34, CD105, CD44, CD73, CD166, CD31, HLA-DR and VE-caderine). Following immunoselection 9.5–17.1 × 106 cells were recovered from MPB samples. Cultured cells reached confluency in 3–4 weeks on first passage and in two weeks thereafter. Immunophenotyping showed negativity for CD45 antigen. The absence of growth factors in culture medium conditioned MSC growth capability, while the addition of PDGF-BB+EGF or b-FGF was able to boost the number of CD45−/CD73+/CD90+ cells in culture (see figure). However expansion remains still sub-optimal, having been reached in 8/17 samples. In conclusion, we demonstrate that MSC can be obtained from MPB, but expansion requires longer time period and appears more difficult compared to bone marrow. Therefore, further studies need to be conducted to find better culture conditions and optimal growth factor combinations to support MPB-derived MSC expansion. Figure Figure

Clinical applications of angiogenic growth factors and their inhibitors

10.1038/70928 ◽  
1999 ◽  
Vol 5 (12) ◽  
pp. 1359-1364 ◽  
Author(s):  
Napoleone Ferrara ◽  
Kari Alitalo
Keyword(s):  
Growth Factors ◽  
Clinical Applications ◽  
Angiogenic Growth Factors

Biology and Clinical Applications of Hemopoietins in Pediatric Practice

PEDIATRICS ◽  
1992 ◽  
Vol 90 (5) ◽  
pp. 716-728
Author(s):  
Wayne L. Furman ◽  
William M. Crist
Keyword(s):  
Growth Factors ◽  
Growth Factor ◽  
Cell Growth ◽  
Blood Cells ◽  
Clinical Applications ◽  
Colony Stimulating Factor ◽  
Cyclic Neutropenia ◽  
Macrophage Colony Stimulating Factor ◽  
Macrophage Colony ◽  
Stimulating Factor

The differentiation, proliferation, and viability of hemopoietic cells are regulated by glycoproteins variously referred to as colony-stimulating factors (CSFs), growth factors, or hemopoietins. To date, 12 interleukins, 3 CSFs, erythropoietin, and a stem cell growth factor (kit ligand, or mast cell growth factor) are known to regulate hemopoiesis. The identification and purification of human hemopoietic growth factors (cytokines) have recently permitted a more detailed analysis of their role in hemopoiesis. Cloning of the genes that encode these CSFs has led to largescale production of their protein products for clinical application. Recent clinical trials of these cytokines in adults and children with a variety of diseases affecting hemopoiesis have already yielded dramatic benefits. For example, patients with formerly serious or fatal diseases, such as cyclic neutropenia or Kostmann syndrome (congenital agranulocytosis), have shown striking reductions in infections, marked improvement in their quality of life, and no serious side effects during treatment with recombinant human granulocyte colony-stimulating factor (rhG-CSF). Here we summarize what is known about the biology and clinical utility of five of these CSFs (recombinant human erythropoietin [rh-EPO], rhG-CSF, granulocyte-macrophage colony-stimulating factor [rhGM-CSF], macrophage colony-stimulating factor [rhM-CSF], and interleukin-3 [rhIL-3]), which are in clinical use in children. We also indicate future applications for these and other hemopoietins. Table 1 outlines characteristics of the five agents, and Table 2 lists their clinical applications. HEMOPOIETINS AND HEMOPOIESIS Hemopoiesis is a complex and dynamic process during which a relatively small number of stem cells with self-renewal capacity give rise to lineage-restricted progenitor cells that mature into red blood cells, leukocytes (white blood cells), or platelets (see Figure).

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