Here’s a roundup of recent clinical trial news:
- Abiomed Receives Conditional FDA Approval for Study with Impella 2.5 in Reducing Heart Muscle Damage Following PCI in STEMI Patients
Abiomed, Inc. (NSDQ:ABMD), a provider of heart support technologies, announced it has received conditional approval from the Food & Drug Administration to begin MINI-AMI, a prospective, randomized, controlled multi-site trial to assess the potential role of the Impella® 2.5 in reducing infarct size in patients with ST-elevation myocardial infarction (STEMI). The primary objective of this study is to evaluate whether the adjunctive use of the Impella 2.5 for 24 hours following primary percutaneous intervention (PCI) for STEMI has the potential to limit the infarction of at-risk myocardium compared to primary PCI with routine post-PCI care.
- Midterm results from a multicenter registry on the treatment of infrainguinal critical limb ischemia using a heparin-bonded ePTFE graft
Over a 7-year period ending in 2008, 425 patients presenting with critical limb ischemia underwent infrainguinal revascularization using a heparin-bonded ePTFE graft in seven Italian vascular centers. The use of a heparin-bonded ePTFE graft provides good early and midterm results, with low rates of late amputations. Primary and secondary patency made this graft an excellent alternative to autologous saphenous vein when it is absent, unsuitable, or of poor quality.
- Inspire Medical Systems Announces FDA approval for Pivotal Clinical Trial
Inspire Medical Systems, a developer of neuro-stimulation therapies for the treatment of obstructive sleep apnea (OSA), announced that the company has received approval from the Food and Drug Administration (FDA) to begin its STAR pivotal clinical trial.
- KineMed reports clinical data on novel method for identifying and verifying biomarker candidates in cerebral spinal fluid for Parkinson’s Disease to the Michael J. Fox Foundation
KineMed Inc. presents data on the new use of cerebrospinal fluid biomarkers of microtubule-mediated neuronal transport for the monitoring of disease progression and the advancement of therapeutic interventions in Parkinson’s disease, a debilitating neurological condition with considerable unmet need for new treatments.
- New study shows DNA test highly accurate in predicting curve progression in scoliosis Patients
A new study shows the SCOLISCORE™ AIS Prognostic Test, a DNA test to determine the likelihood of curve progression in children with mild adolescent idiopathic scoliosis (AIS), an abnormal curvature of the spine, is 99 percent accurate in predicting which children are least likely to progress to a severe curve (Cobb Angle of 40 degrees or more).
- California Stem Cell Inc. files IND to commence phase I clinical trial in spinal muscular atrophy
California Stem Cell, Inc. and Families of Spinal Muscular Atrophy (FSMA) announced that CSC has filed an investigational new drug application with the US Food & Drug Administration for approval to commence a Phase I safety study on a jointly-developed stem cell-derived motor neuron transplantation therapy for Spinal Muscular Atrophy Type I.
- Micell Technologies enrolls first patient in DESSOLVE I first-in-human study of MiStent DES
Micell Technologies, TM Inc. announced it has enrolled at Mercy Hospital in Auckland, New Zealand, the first patient in DESSOLVE I (DES with Sirolimus and a bioabsorbable polymer for the treatment of patients with de novo lEsions in the native coronary arteries), a first-in-human clinical trial of the company’s investigational MiStentTM Drug Eluting Coronary Stent System.
- Advanced Cell Technology files IND with FDA for first clinical trial using embryonic stem cells to treat dry AMD
Advanced Cell Technology Inc. (OTC:ACTC) announced that it has filed an Investigational New Drug (IND) Application with the US Food & Drug Administration to initiate a Phase I/II multicenter study using human embryonic stem cell (hESC) derived retinal pigment epithelial (RPE) cells to treat patients with Dry Age-Related Macular Degeneration.
- Phase 2 clinical study demonstrates safety and efficacy of Vitala™ continence control device
Vitala™ a novel, non-invasive continence control device, demonstrated safety and efficacy in providing up to 8 hours of temporary continence to people with an end colostomy, according to results of a study published in the journal Diseases of the Colon & Rectum.
- Acupuncture changes brain’s perception and processing of pain
Using functional magnetic resonance imaging (fMRI), researchers have captured pictures of the brain while patients experienced a pain stimulus with and without acupuncture to determine acupuncture’s effect on how the brain processes pain. Results of the study, which the researchers say suggest the effectiveness of acupuncture, were presented at the annual meeting of the Radiological Society of North America (RSNA).
- AAOS fails to consider new research offering level 1 evidence in favor of vertebroplasty
Results of a large-scale study, “Vertebroplasty vs. Conservative Treatment in Osteoporotic Vertebral Compression Fractures” (VERTOS II), provides Level 1 evidence that vertebroplasty helps relieve the pain caused by vertebral compression fractures at an acceptable cost. The study also helps define the type of patient for whom the procedure is most suitable and effective.
- Abnormal blood vessel function found in women with broken heart syndrome
A team of Mayo Clinic researchers has found that patients with broken heart syndrome, also known as apical ballooning syndrome (ABS), have blood vessels that don’t react normally to stress. These results offer clues to the cause of this rare syndrome and may help with efforts to identify patients who are more vulnerable to mental stress so that appropriate therapies can be developed. The study is published online in the Journal of the American College of Cardiology.
- A less invasive method of determining the stage of non-small-cell lung cancer proves effective
A study published in The Journal of the American Medical Association showed that patients may not need a surgical procedure to for doctors to learn the stage of their lung dancer.
- OrbusNeich’s Genous™ stent shows favorable outcomes for treatment of coronary artery bifurcation lesions compared to bare metal stents
OrbusNeich’s Genous Stent shows favorable outcomes compared to bare metal stents (BMS) for the treatment of coronary artery bifurcation lesions, according to data published online in the journal Atherosclerosis.