Clinical Research Directory

Expanded Access Protocol: Umbilical Cord Blood Infusions for Children With Brain Injuries

This protocol is designed to enable access to intravenous infusions of banked umbilical cord blood (CB), that is thawed and not more than minimally manipulated, for children with various brain disorders. Children with cerebral palsy, congenital hydrocephalus, apraxia, stroke, hypoxic brain injury and related conditions will be eligible if they have normal immune function and do not qualify for, have previously participated in, or are unable to participate in an active cell therapy clinical trial at Duke Medicine. For the purpose of this protocol the term children refers to patients less than 26 years of age. Cord blood is administered as a cellular infusion without prior treatment with chemotherapy or immunosuppression. The mechanism of action is through paracrine signaling of cord blood monocytes inducing endogenous cells to repair existing damage.

Group-based Emotional Awareness and Expression Therapy to Support Recovery After Acquired Brain Injury: A Clinical Development and Evaluation Study

Difficulties in understanding and managing emotions may hinder recovery, rehabilitation, and participation in everyday life after acquired brain injury (ABI). Yet interventions targeting emotional adjustment after ABI remain limited. The aim of the study is to investigate whether emotion-focused group therapy, based on Emotional Awareness and Expression Therapy (EAET), can support recovery after ABI. The intervention helps participants identify, process, and express emotions and needs related to their illness and changed life circumstances. Effects on emotional functioning, quality of life, activity, and participation will be assessed over time, alongside interviews exploring participants' experiences.