We conducted the first-regenerative medicine cellular therapy for underactive bladder (UAB) in an FDA-approved, compassionate-use IND trial to evaluate treatment safety and potential clinical efficacy of autologous muscle-derived stem cells (AMDC) on a patient with UAB. No study-related adverse events or side effects were reported. In the 1-year follow-up period, the subject denied any gross hematuria, urgency, frequency or infection.
View Article and Find Full Text PDFObjectives: A Federal Drug Administration-approved, compassionate-use, investigational new drug single-subject trial was conducted to evaluate the safety and clinical outcomes of intravesical instillation of liposomes in a woman with ulcerative interstitial cystitis/painful bladder syndrome (IC/PBS).
Methods: After obtaining informed consent, the 48-year-old woman, diagnosed with ulcerative IC/PBS, received four weekly instillations of intravesical liposomes. Subsequently she was evaluated for 8 weeks post bladder instillation.
Objective: To examine the functional status of persons surviving a severe penetrating traumatic brain injury (TBI) resulting from a gunshot wound who require inpatient rehabilitation.
Design: Data were collected prospectively at 4 different time periods: rehabilitation admission and discharge and year 1 and year 2 postinjury.
Setting: Rehabilitation hospital within a Traumatic Brain Injury Model System.