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"Chancellor, Deborah"
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Intradetrusor injection of adult muscle-derived cells for the treatment of underactive bladder: pilot study
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. A reduction in maximum cystometric capacity from 844 to 663 mL was observed, and the patient was able to void small amounts but continues to require self-catheterization 1 year after AMDC injection. Intradetrusor injection of AMDC is safe, minimally invasive and a promising treatment option for the UAB.
Journal Article
Improved global response outcome after intradetrusor injection of adult muscle-derived cells for the treatment of underactive bladder
We report on the first regulatory approved clinical trial of a prospective open-label physician-initiated study assessing the safety and efficacy of intradetrusor injected Autologous Muscle Derived Cells (AMDC) treatment for underactive bladder (UAB). 20 non-neurogenic UAB patients were treated. Approximately 50–250 mg of quadriceps femoris muscle was collected using a spirotome 8-gauge needle. The muscle biopsy samples were sent to Cook MyoSite (Pittsburgh, PA) for processing, isolation, and propagation of cells. Research patients received approximately 30 intradetrusor injections of 0.5 mL delivered to the bladder, for a total of 15 mL and 125 million AMDC, performed utilizing a flexible cystoscope under direct vision using topical local anesthesia. Follow-up assessments included adverse events and efficacy via voiding diary and urodynamic testing at 1, 3, 6 and 12 months post-injection. An optional second injection was offered at the end of the 6 months visit. 20 patients received the first injection and all 20 patients requested and received a second injection. Median patient age was 65 years old (range 41–82 years). There were 16 male (80%) and 4 female (20%) patients. Etiology included 7 men (35%) with persistent urinary retention after transurethral resection of the prostate for benign prostatic hyperplasia and 13 patients (65%) with idiopathic chronic urinary retention. At the primary outcome time point of 12 months, 11/19 patients (58%) reported a global response assessment (GRA) ≥ 5, showing slight to marked improvement in their UAB symptoms, compared to 6/20 (30%) patients at 3 months post-injection. No serious procedure or treatment-related adverse events occurred. Noted improvements included: decreased post void residual urine volume, increased voiding efficiency, and decreased catheter use. Intradetrusor-injected AMDC as a treatment for UAB was successfully completed in a 20-patient trial without serious adverse event and with signal of efficacy. Cellular therapy may be a promising novel treatment for catheter-dependent chronic urinary retention. A multicenter controlled trial is needed to further assess the promise of regenerative medicine in the treatment of lower urinary tract dysfunction.
Journal Article
Liposomal bladder instillations for IC/BPS: an open-label clinical evaluation
Purpose
Intravesical instillation of liposomes is a potentially new therapeutic option for subjects with interstitial cystitis/bladder pain syndrome (IC/BPS). The aim of this study was to explore the safety and clinical outcomes of 4 weekly instillations of sphingomyelin liposomes in an open-label cohort of subjects with IC/BPS.
Methods
Fourteen symptomatic IC/BPS subjects were treated with intravesical liposomes once a week for 4 weeks. Safety measurements included laboratory specimen collection, vital signs, post-void residual, and assessment of adverse events (AEs). Efficacy measurements included pain visual analog scales (VAS), voiding diaries, global response assessments (GRAs), and O’Leary-Sant Interstitial Cystitis Symptom and Problem Indices (ICSI and ICPI).
Results
No treatment-related AEs were reported at any time over the course of the study. Urgency VAS scores significantly decreased at 4 weeks (
p
= 0.0029) and 8 weeks (
p
= 0.0112) post-treatment. Pain VAS scores significantly decreased at 4 weeks post-treatment (
p
= 0.0073). Combined ICSI and ICPI scores improved significantly at 4 and 8 weeks (
p
= 0.002 for both time points) post-treatment. Responses to GRA showed improvement at 4 weeks post-instillation. No significant decrease in urinary frequency was found.
Conclusions
Sphingomyelin liposome instillations were well tolerated in subjects with IC/BPS with no AEs attributed to the test article. Treatment was associated with improvements in pain, urinary urgency, and overall symptom scores. Placebo-controlled clinical trials are needed to assess this potential therapy for IC/BPS.
Journal Article
Food waste
Instructs readers on how to become conscientious food consumers and future environmentalists.
Book
Development of long term use of psychotropic drugs by general practice patients
From 1984 to 1986 a prospective study was conducted of 104 general practice patients who started treatment with a benzodiazepine or an antidepressant drug. The duration of reported use of the drugs was two months for 45% of patients, four months for 17% of patients, and six months for 15%. Type of drug, age, and level of education were found to be predictive of continuing use. General practitioners have a significant effect on their patients' use of drugs and, with careful selection and review when prescribing, may help to prevent dependence on psychotropic drugs.
Journal Article
Good manners
Find out why punctuality and being polite are so important in life! Good Manners encourages young readers to explore their behavior and the effect it can have on the people around them.
Book
Buyers ignoring home deal
ONLY 3724 investors have taken up the state government's 50 per cent discount on stamp duty paid on new homes.
Newspaper Article