Recommendations for procurement of starting materials by apheresis for advanced therapy medicinal products.

Activities involved in the production of certain advanced therapy medicinal products (ATMPs) require standardized approaches to mononuclear cell procurement to ensure the highest product quality, safety and process efficiency. These aims must be achieved while meeting regulatory and accreditation requirements for the procurement of mononuclear cells as starting materials. Mononuclear cells constitute the starting materials for many ATMPs, and this article sets out recommendations for procurement by clinical apheresis, addressing the variation among existing working practices and different manufacturers' requirements that currently poses a challenge when managing multiple different protocols.

Laboratory Determination of Gravimetric Correction Factors for Real-time Area Measurements of Electronic Cigarette Aerosols.

Research on secondhand electronic cigarette (ECIG) aerosol exposure using aerosol monitors has demonstrated that ECIG use can generate high concentrations of particulate matter (PM) and impact indoor air quality. However, quantifying indoor air PM concentrations using real-time optical monitors with on-site calibration specifically for different PM exposures has not been established. Therefore, the ECIG aerosol filter correction factors were calculated for different PM sizes (PM, PM, and PM) and different aerosol optical monitors, the MiniWRAS, pDR, and SidePak.

Options for imaging cellular therapeutics in vivo: a multi-stakeholder perspective.

Cell-based therapies have been making great advances toward clinical reality. Despite the increase in trial activity, few therapies have successfully navigated late-phase clinical trials and received market authorization. One possible explanation for this is that additional tools and technologies to enable their development have only recently become available.

Dopamine transporter neuroimaging accurately assesses the maturation of dopamine neurons in a preclinical model of Parkinson's disease.

Background: Significant developments in stem cell therapy for Parkinson's disease (PD) have already been achieved; however, methods for reliable assessment of dopamine neuron maturation in vivo are lacking. Establishing the efficacy of new cellular therapies using non-invasive methodologies will be critical for future regulatory approval and application. The current study examines the utility of neuroimaging to characterise the in vivo maturation, innervation and functional dopamine release of transplanted human embryonic stem cell-derived midbrain dopaminergic neurons (hESC-mDAs) in a preclinical model of PD.

Management of Residual or Recurrent Disease Following Thermal Ablation of Renal Cortical Tumors.

Management of residual or recurrent disease following thermal ablation of renal cortical tumors includes surveillance, repeat ablation, or surgical extirpation. We present a multicenter experience with regard to the management of this clinical scenario. Prospectively maintained databases were reviewed to identify 1265 patients who underwent cryoablation (CA) or radiofrequency ablation (RFA) for enhancing renal masses.

Tumorigenicity assessment of cell therapy products: The need for global consensus and points to consider.

Pluripotent stem cells offer the potential for an unlimited source for cell therapy products. However, there is concern regarding the tumorigenicity of these products in humans, mainly due to the possible unintended contamination of undifferentiated cells or transformed cells. Because of the complex nature of these new therapies and the lack of a globally accepted consensus on the strategy for tumorigenicity evaluation, a case-by-case approach is recommended for the risk assessment of each cell therapy product.

Report of the international conference on manufacturing and testing of pluripotent stem cells.

Sessions included an overview of past cell therapy (CT) conferences sponsored by the International Alliance for Biological Standardization (IABS). The sessions highlighted challenges in the field of human pluripotent stem cells (hPSCs) and also addressed specific points on manufacturing, bioanalytics and comparability, tumorigenicity testing, storage, and shipping. Panel discussions complemented the presentations.

Integrating a 19F MRI Tracer Agent into the Clinical Scale Manufacturing of a T-Cell Immunotherapy.

Leukocyte immunotherapies have made great progress in the treatment of cancer. Recent reports on the treatment of B-cell malignancies using Chimeric Antigen Receptor and affinity enhanced T-Cell Receptor therapies have demonstrated encouraging clinical results. As investigators begin to explore the treatment of solid tumors with these cells, the hurdle of evaluating T-cell homing to and persistence at the site of disease remain.

Small renal mass biopsy--how, what and when: report from an international consensus panel.

To discuss the use of renal mass biopsy (RMB) for small renal masses (SRMs), formulate technical aspects, outline potential pitfalls and provide recommendations for the practicing clinician. The meeting was conducted as an informal consensus process and no scoring system was used to measure the levels of agreement on the different topics. A moderated general discussion was used as the basis for consensus and arising issues were resolved at this point.

Clinical, pathologic, and functional outcomes after nephron-sparing surgery in patients with a solitary kidney: a multicenter experience.

Background And Purpose: Surgical management of a renal neoplasm in a solitary kidney is a balance between oncologic control and preservation of renal function. We analyzed patients with a renal mass in a solitary kidney undergoing nephron-sparing procedures to determine perioperative, oncologic, and renal functional outcomes.

Patients And Methods: A multicenter study was performed from 12 institutions.

Percutaneous renal cryoablation of angiomyolipomas in patients with solitary kidneys.

Objectives: To determine the feasibility and safety of performing percutaneous cryoablation of angiomyolipomas (AMLs) in patients with solitary kidneys.

Methods: Three patients with AMLs involving a solitary kidney underwent computed tomography-guided percutaneous cryoablation. All lesions were located in the lateral/posterior part of the kidney, allowing for safe access from the skin for cryoprobe insertion.

Oncologic outcomes for ablative therapy of kidney cancer.

Needle ablative therapies for small incidental renal masses are emerging as alternatives to traditional extirpative surgery. Reasons include their associated decreased morbidity, shorter convalescence, and the ability to avert the higher risk of extirpative surgery in an aging patient population. Cryoablation (CA) and radiofrequency ablation are the two most thoroughly studied needle ablative methods used for renal cancer.

Imaging associated with percutaneous and intraoperative management of renal tumors.

As new minimally invasive treatment options for small renal tumors such as laparoscopic partial nephrectomy (LPN), radiofrequency ablation (RFA), and cryoablation(CA) have been developed, the reliance upon imaging technologies, both intraoperatively and postoperatively, has expanded greatly. CT, MRI, and ultrasonography (US)have proven themselves extremely useful in this regard, but their utility requires a thorough understanding of each modality's limitations, proper intraoperative use, and expected postoperative findings. This article discusses intraoperative use of US for LPN,RFA, and CA.

Renal cell carcinoma and end stage renal disease.

Purpose: Patients with ESRD secondary to acquired renal cystic disease have been reported to have a higher incidence of RCC than the general population. We examined the clinical and pathological significance of incidental renal masses in patients with ESRD.

Materials And Methods: From January 1994 to July 2000, 852 consecutive patients with ESRD who were being considered for renal transplantation at University of Mississippi Medical Center were evaluated with renal ultrasound as part of assessment for possible kidney transplantation.

Retinoic acid and oncostatin M combine to promote cartilage degradation via matrix metalloproteinase-13 expression in bovine but not human chondrocytes.

Objectives: Retinoic acid (RetA) and oncostatin M (OSM) have both been shown to mediate potent effects with respect to extracellular matrix integrity. This study assesses the effects of a RetA + OSM combination on cartilage catabolism.

Methods: Animal and human cartilage samples were used to assess the ability of RetA + OSM to promote the release of collagen and proteoglycan fragments, which was determined by measuring glycosaminoglycan and hydroxyproline, respectively.

Defining the complications of cryoablation and radio frequency ablation of small renal tumors: a multi-institutional review.

Purpose: Ablative treatments (cryoablation or radio frequency ablation) for renal cell carcinoma aim to decrease morbidity by treating renal tumors in situ, eliminating the need for extirpation. These technologies have potential for complications previously unassociated with renal tumor treatment. We identified complications associated with percutaneous and laparoscopic ablative treatment of renal tumors.

Interventional magnetic resonance image-guided percutaneous cryoablation of renal tumors.

We describe the first two cases of percutaneous cryoablation under magnetic resonance imaging guidance. To date, this minimally invasive procedure has been used for the treatment of renal cell tumors in patients who cannot tolerate or refuse surgical nephrectomy. The two patients described showed no evidence of recurrence or complications 35 and 36 months after the procedure.

Cryoablation of renal tumours in patients with solitary kidneys.

Objective: To investigate the use of cryoablation for small renal tumours (
Patients And Methods: Patients with a radiographically documented solid renal mass in a solitary kidney were evaluated for treatment with percutaneous cryoablation. Under general anaesthesia the patients were placed in an interventional magnetic resonance imaging (MRI) unit.

Expression of HIF-1 and ubiquitin in conventional renal cell carcinoma: relationship to mutations of the von Hippel-Lindau tumor suppressor gene.

Conventional clear cell renal cell carcinomas (cRCC) have mutations of the von Hippel-Lindau (VHL) tumor suppressor gene at 3p25 in approximately 50% of cases. The VHL gene normally regulates ubiquitin-mediated proteolysis of hypoxia-inducible factor 1alpha (HIF-1alpha); in cell lines, VHL inactivation blocks HIF-1alpha proteolysis, resulting in increased HIF-1 expression. This study was undertaken to investigate the relationship between VHL mutations and the expression of ubiquitin and HIF-1alpha in cRCC.

Effects of cryoablation on short-term development of urinary fistulas in the porcine kidney.

Purpose: To determine the effect of cryoablation on the collecting system in the porcine kidney and the possible development of pelvic injury or fistula.

Materials And Methods: Six kidneys from three domestic swine were utilized. Under MRI guidance, a 3-mm cryoprobe was placed percutaneously and advanced to a point adjacent to the collecting system.

Prostate specific antigen measurements after minimally invasive surgery of the prostate in men with benign prostatic hypertrophy.

There is a trend of minimally invasive surgery in the treatment of benign prostatic hypertrophy (BPH). Studies have examined levels of prostate specific antigen (PSA) in patients after open prostatectomy or transurethral resection of prostate (TURP) and noted reset of PSA to lower values after surgery. We reviewed PSA levels in patients after minimally invasive procedures to determine if levels were reset.

Three-year follow-up of laser prostatectomy versus transurethral resection of the prostate in men with benign prostatic hyperplasia.

Objectives: To present our 3-year data comparing laser prostatectomy and transurethral resection of the prostate (TURP) for benign prostatic hyperplasia (BPH). Laser prostatectomy was one of the first new minimally invasive treatment modalities for BPH, and few reports of the long-term results of this treatment regimen have been published.

Methods: One hundred men with BPH in whom medical therapy had failed were randomized to undergo either laser prostatectomy or TURP.

Percutaneous renal cryoablation of renal tumors in patients with von Hippel-Lindau disease.

Purpose: We determine the feasibility and safety of performing percutaneous cryoablation of renal tumors in patients with von Hippel-Lindau disease.

Materials And Methods: We selected 2 men and 2 women with von Hippel-Lindau disease and radiographic determined solid renal tumors were selected to undergo percutaneous cryoablation. All patients underwent standard preoperative evaluation.