Randomized Trial to Evaluate Effects of Peer- and Clinician-Led Interventions for Caregivers of Individuals With Acquired Brain Injury.

Objective: To evaluate the effectiveness of 2 interventions for caregivers of patients with acquired brain injury (ABI) transitioning home after inpatient rehabilitation, to prepare them for the role of caregiving and reduce stress and depression.

Design: Controlled trial with participants randomly assigned to (1) usual care (UC), (2) clinician-delivered Problem-Solving Training (PST), or (3) peer-led Building Better Caregivers (BBC) training; both experimental interventions initiated during the inpatient rehabilitation stay, delivered virtually, of similar intensity (six 60-minute sessions), and focused on managing stress and building skills related to caregiving.

Setting: Nonprofit rehabilitation hospital specializing in care of persons with acquired brain and spinal cord injuries.

An In Vitro Assessment of Immunostimulatory Responses to Ten Model Innate Immune Response Modulating Impurities (IIRMIs) and Peptide Drug Product, Teriparatide.

Understanding, predicting, and minimizing the immunogenicity of peptide-based therapeutics are of paramount importance for ensuring the safety and efficacy of these products. The so-called anti-drug antibodies (ADA) may have various clinical consequences, including but not limited to the alteration in the product's distribution, biological activity, and clearance profiles. The immunogenicity of biotherapeutics can be influenced by immunostimulation triggered by the presence of innate immune response modulating impurities (IIRMIs) inadvertently introduced during the manufacturing process.

Innate Immunity Modulating Impurities and the Immunotoxicity of Nanobiotechnology-Based Drug Products.

Innate immunity can be triggered by the presence of microbial antigens and other contaminants inadvertently introduced during the manufacture and purification of bionanopharmaceutical products. Activation of these innate immune responses, including cytokine secretion, complement, and immune cell activation, can result in unexpected and undesirable host immune responses. These innate modulators can also potentially stimulate the activation of adaptive immune responses, including the formation of anti-drug antibodies which can impact drug effectiveness.

Effects of Peer Mentoring for Caregivers of Patients With Acquired Brain Injury: A Preliminary Investigation of Efficacy.

Objective: To evaluate effectiveness of a peer mentor intervention for caregivers of patients with acquired brain injury (ABI) in encouraging caregiver participation in support services to prepare them for the role of caregiving and in reducing caregiver stress and depression.

Design: Controlled trial with participants randomized to either usual care or 1-to-1 visits with a family caregiver peer mentor during the ABI inpatient rehabilitation stay.

Setting: Nonprofit rehabilitation hospital specializing in care of persons with brain and spinal cord injury.

Tumor Targeted Delivery of an Anti-Cancer Therapeutic: An In Vitro and In Vivo Evaluation.

The limited effectiveness of current therapeutics against malignant brain gliomas has led to an urgent need for development of new formulations against these tumors. Chelator Dp44mT (di-2-pyridylketone-4,4-dimethyl-3-thiosemicarbazone) presents a promising candidate to defeat gliomas due to its exceptional anti-tumor activity and its unique ability to overcome multidrug resistance. The goal of this study is to develop a targeted nano-carrier for Dp44mT delivery to glioma tumors and to assess its therapeutic efficacy in vitro and in vivo.

Optimization of the Single Emulsion Method for Encapsulation of a Cancer Drug in Nanoparticles.

The goal of this study is to apply and optimize the single emulsion technique for encapsulation of an anti-tumor drug, Di-2-pyridylketone-4,4-dimethyl-3-thiosemicarbazone (Dp44mT), in nanoparticles (NPs) of poly(lactic-co-glycolic acid) (PLGA), as a step towards targeted delivery of this drug. We previously showed that the nanoprecipitation technique can effectively produce PLGA NPs carrying this drug. Here, we aim to examine the single emulsion technique as an alternative for the preparation of these NPs and to compare the resultant NPs to those from nanoprecipitation.

Development and in vitro assessment of an anti-tumor nano-formulation.

This study aims to develop a new anti-cancer formulation based on the chelator Dp44mT (Di-2-pyridylketone-4,4-dimethyl-3-thiosemicarbazone). Dp44mT has outstanding anti-tumor activity and the unique ability to overcome multidrug-resistance in cancer cells. This highly toxic compound has thus far only been applied in free form, limiting its therapeutic effectiveness.