Clinical Trial – A Randomized Phase II Study of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplant
The UCB transplant is a type of stem cell transplant used to treat cancer of the blood or
lymph glands. The UCB transplant has advantages over other types of transplants such as ease
of obtaining the umbilical cord blood, absence of donor risks, reduced risks of contagious
infections, and the availability for immediate use. The UCB transplant is also associated
with a lower incidence of graft versus host disease, or GvHD (in GvHD, the transplanted graft
attacks the recipient organs).
Clinical Trial – Hyperbaric Oxygen Therapy for Cognition in Diabetic Elderly at High Dementia Risk
An urgent need exists to identify effective interventions to arrest or reverse dementia and
cognitive loss at its earliest stages. The proposed pilot randomized clinical trial will
investigate the short and long-term effects of hyperbaric oxygen therapy on cognitive
functioning, cerebral blood flow, and glucose uptake in diabetic elderly with mild cognitive
impairment. and provide the basis for a large-scale multi-center study of hyperbaric oxygen
therapy effects on cognition in diabetes. The potential to preserve, or even enhance,
cognition in elderly at high risk of cognitive decline and dementia has major implications
for the affected individuals and their support systems that bear the social and financial
burdens of long-term caregiving.
Clinical Trial – Efficacy Study of Riociguat and Its Effects on Exercise Performance and Pulmonary Artery Pressure at High Altitude
During ascent to high altitude there is a physiologic response to hypoxia that results in an
elevated pulmonary arterial pressure associated with decreased exercise performance,
altitude-induced pulmonary hypertension, and high altitude pulmonary edema (HAPE). Riociguat
is a novel agent from Bayer Pharmaceuticals that has already demonstrated effectiveness in
the treatment of pulmonary hypertension, and it may prove to be beneficial in cases of
altitude-induced pulmonary hypertension or HAPE. This research study, composed of 20 healthy
volunteers ages 18-40 years, will attempt to mimic the decreased oxygen supply and elevated
pulmonary artery pressures found in conditions of high altitude, allowing observation of the
effects of riociguat and exercise on pulmonary arterial pressure, arterial oxygenation, and
exercise performance. Prior to entering the hypobaric chamber, subjects will have radial
arterial lines and pulmonary artery catheters placed to obtain arterial and pulmonary artery
pressure measurements. Subjects will then enter the hypobaric chamber and perform exercise
tolerance tests at a simulated altitude of 15,000 feet on an electrically braked ergometer
(exercise bike) before and after administration of riociguat. If, after administration of
riociguat and exposure to a simulated altitude of 15,000 feet, the exercise performance is
improved and observed pulmonary artery pressures are lower than those measurements seen prior
to administration of riociguat, this could lead to development of a prophylactic and/or
treatment strategy for HAPE and high-altitude pulmonary hypertension. Statistical analysis
will compare the variables of pulmonary artery pressure, radial arterial pressure,
ventilation rate, cardiac output, PaO2, and work rate at exhaustion before and after
administration of the drug riociguat. The investigator’s hypothesis is that riociguat will
decrease pulmonary artery pressure and improve gas exchange and exercise performance at
altitude.