Comparative Clinical Outcomes After Intra-articular Injection With Adipose-Derived Cultured Stem Cells or Noncultured Stromal Vascular Fraction for the Treatment of Knee Osteoarthritis.

BACKGROUND: Intra-articular injection of adipose-derived stem cells (ASCs) has shown promise for improving symptoms and cartilage quality in the treatment of osteoarthritis (OA). However, while most preclinical studies have been performed with plastic-adherent ASCs, most clinical trials are being conducted with the stromal vascular fraction (SVF), prepared from adipose tissue without prior culture. PURPOSE: To directly compare clinical outcomes of intra-articular injection with ASCs or SVF in patients with knee OA. STUDY DESIGN: Cohort study; Level of evidence, 3. METHODS: The authors retrospectively compared 6-month outcomes in 42 patients (59 knees) receiving intra-articular injection with 12.75 million ASCs and 38 patients (69 knees) receiving a 5-mL preparation of SVF. All patients had Kellgren-Lawrence grade 2, 3, or 4 knee OA and had failed standard medical therapy. The visual analog scale (VAS) pain score and Knee injury and Osteoarthritis Outcome Score (KOOS) at baseline and 1, 3, and 6 months after injection were considered as outcomes. Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) criteria were also used to assess positive response. A repeated measures analysis of variance was used for comparison between the treatment groups. RESULTS: No major complications occurred in either group. The SVF group had a higher frequency of knee effusion (SVF 8%, ASC 2%) and minor complications related to the fat harvest site (SVF 34%, ASC 5%). Both groups reported improvements in pain VAS and KOOS domains. Specifically, in the ASC group, symptoms improved earlier (by 3 months; P < .05) and pain VAS decreased to a greater degree (55%; P < .05) compared with the SVF group (44%). The proportion of OMERACT-OARSI responders in the ASC group was slightly higher (ASCs, 61%; SVF, 55%; P = .25). CONCLUSION: It was observed that both ASCs and SVF resulted in clinical improvement in patients with knee OA, but that ASCs outperform SVF in the early reduction of symptoms and pain with less comorbidity.

Stem cells: past, present, and future.

In recent years, stem cell therapy has become a very promising and advanced scientific research topic. The development of treatment methods has evoked great expectations. This paper is a review focused on the discovery of different stem cells and the potential therapies based on these cells. The genesis of stem cells is followed by laboratory steps of controlled stem cell culturing and derivation. Quality control and teratoma formation assays are important procedures in assessing the properties of the stem cells tested. Derivation methods and the utilization of culturing media are crucial to set proper environmental conditions for controlled differentiation. Among many types of stem tissue applications, the use of graphene scaffolds and the potential of extracellular vesicle-based therapies require attention due to their versatility. The review is summarized by challenges that stem cell therapy must overcome to be accepted worldwide. A wide variety of possibilities makes this cutting edge therapy a turning point in modern medicine, providing hope for untreatable diseases.

The advanced therapy classification procedure. Overview of experience gained so far.

The classification procedure, introduced by the European Regulation on advanced therapy medicinal products (ATMPs), has received a tremendous interest from companies, academic and public sponsors developing ATMPs. This procedure gives companies the opportunity to verify whether or not the product they are developing can be considered an ATMP and can therefore benefit from the new regulatory pathway introduced in the European Union for these types of medicinal products. This procedure is optional, free of charge and may take place at any stage of the development of an ATMP in advance of applying for a marketing authorisation. In case of doubt, briefing meetings organised by the European Medicines Agency Innovation Task Force may help preparing for an ATMP classification and are a starting point for the interactions between the Agency and the developers of ATMPs. This article reviews the advantages of the classification procedure for both the developers of ATMPs and the European regulatory network. Since the introduction of this procedure and up to 10 November 2010, the Committee for Advanced Therapies (CAT) has finalised 38 applications for classification.

Stem cell transplantation: brief review and current status.

In recent years stem cell has come up as a great advance in therapy for a number of illnesses and has potential for revolutionising the medical field. Right from myelodysplastic syndrome to amyloidosis it has been tried. The present review is a modest endeavour to acquaintain in brief about current status of stem cells.

From stem cell to solid organ. Bone marrow, peripheral blood or umbilical cord blood as favorable source?

Adult stem cells (ASC) have becoming a great domain of research by their promising interest for the regenerative medicine. For some years, the number of publications has been increasing, displaying the potential of ASC to differentiate in all tissue-lineages, challenging the previous dogma that ASC were restricted to give rise only to specific cells from their tissue of origin. Among the diversity of ASC, hematopoietic stem cells (HSC) have been the most studied and their use in the clinical setting is largely documented. Commonly, HSC have been harvested from the bone marrow, but for some years, two others sources, the peripheral blood and the umbilical cord blood have been introduced. All these HSC posses their own molecular characteristics and degree of maturity and represent a more or less good candidate to participate in the cellular-based tissue regeneration. We have reviewed the different parameters allowing to define which subset could be the more favorable such as the accessibility to the pool of HSC; the quantity of available cells; the tolerability of host-engraftment and the capacity of the cells to home correctly to the required site of damaged. Besides, recently, the molecular profiling of HSC has allowed identifying which subset posses the more promising characteristics.

Here we go again!

New CPT procedure codes are added annually (quarterly for Category II and Category III codes), definitions of existing codes are changed, and codes we have memorized are often deleted and replaced. In addition, guidelines for code assignment are constantly revised and may be altered based upon individual insurance payer interpretation. Remember, a code must accurately represent the service performed, and a code that is "close" to the procedure performed cannot be assigned. If the service performed is not defined by an existing procedure code (CPT Category I, II, III or HCPCS Level II), then an unlisted procedure code must be used. The forms and guidelines to request new codes or changes to procedure code descriptors are currently located on the American Medical Association website in the "CPT Process" section (www.ama-assn.org/ama/ pub/category/3112.html).

Engineering of human hepatocyte lines for cell therapies in humans: prospects and remaining hurdles.

Hepatocyte-based biological therapies are increasingly envisioned for temporary support in acute liver failure and provision of specific-liver functions in liver-based metabolic deficiency. One of the hurdles to develop such therapies is severe shortage of human livers for hepatocyte isolation. To address the issue, we have focused on reversible immortalization of human hepatocytes. Such technology can allow rapid preparation of functional and uniform human hepatocytes. Here we present our strategy to construct transplantable human hepatocyte cell lines.